A Cochrane Review of Superficial Heat or Cold for Low Back Pain

 
SPINE Volume 31, Number 9, pp 998 –1006
                                                                                                       ©2006, Lippincott Williams & Wilkins, Inc.

          A Cochrane Review of Superficial Heat or Cold
          for Low Back Pain

          Simon D. French, MPH, BAppSc(Chiro),* Melainie Cameron, PhD, BAppSc(Osteo), MHSc(Research),†
          Bruce F. Walker, DC, MPH, DrPH,‡ John W. Reggars, DC, MChiroSc,¶ and
          Adrian J. Esterman, PhD, AStat, DLSHTM§

       Study Design. Cochrane systematic review.                              apy provides a small short-term reduction in pain and
       Objective. To assess the effects of superficial heat and               disability in a population with a mix of acute and subacute
   cold therapy for low back pain in adults.                                  low back pain, and that the addition of exercise further
       Summary of Background Data. Heat and cold are com-                     reduces pain and improves function. There is insufficient
   monly used in the treatment of low back pain.                              evidence to evaluate the effects of cold for low back pain
       Methods. We searched electronic databases from in-                     and conflicting evidence for any differences between heat
   ception to October 2005. Two authors independently as-                     and cold for low back pain.
   sessed inclusion, methodologic quality, and extracted                         Key words: systematic review, Cochrane Collabora-
   data, using the criteria recommended by the Cochrane                       tion, heat, cold, low back pain. Spine 2006;31:998 –1006
   Back Review Group.
       Results. Nine trials involving 1,117 participants were
   included. In two trials of 258 participants with a mix of
   acute and subacute low back pain, heat wrap therapy                      Low back pain is a common complaint with the lifetime
   significantly reduced pain after 5 days (weighted mean                   prevalence reported as ranging from 11% to 84%.1 The
   difference [WMD], 1.06; 95% confidence interval [CI],                    cause of pain is nonspecific in about 95% of people pre-
   0.68 –1.45, scale range, 0 –5) compared with oral placebo.
                                                                            senting with acute low back pain, with serious condi-
   One trial of 90 participants with acute low back pain found
   that a heated blanket significantly decreased pain imme-                 tions being rare.2 Chronic low back pain is a well-
   diately after application (WMD, ⫺32.20; 95% CI, ⫺38.69 to                documented disabling condition, costly to both individuals
   ⫺25.71; scale range, 0 –100). One trial of 100 participants              and society.3–5
   with a mix of acute and subacute low back pain examined
                                                                               Different healthcare disciplines commonly use heat
   the additional effects of adding exercise to heat wrap and
   found that it reduced pain after 7 days.                                 and cold treatments for the treatment of low back
       Conclusions. The evidence base to support the com-                   pain.6 –13 Both therapies are simple to apply and are in-
   mon practice of superficial heat and cold for low back                   expensive. They may be used by people with low back
   pain is limited, and there is a need for future higher-                  pain at home or may be employed by practitioners as
   quality randomized controlled trials. There is moderate
   evidence in a small number of trials that heat wrap ther-
                                                                            part of a treatment regimen.
                                                                               Traditionally, ice has been recommended for acute
                                                                            injury and heat has been recommended for longer-term
                                                                            injuries.14,15 Superficial heat methods convey heat by
From the *Australasian Cochrane Centre, Monash Institute of Health
Services Research, Monash University, Clayton, Victoria, Australia;         conduction or convection. Superficial heat elevates the
†Centre for Ageing, Rehabilitation, Exercise, and Sport, School of Hu-      temperature of tissues and provides the greatest effect at
man Movement, Recreation and Performance, Victoria University;
‡School of Chiropractic, Murdoch University, Murdoch, Western Aus-
                                                                            0.5 cm or less from the surface of the skin. However,
tralia; §School of Nursing and Midwifery, University of South Austra-       deep heating is achieved by converting another form of
lia; and ¶private practice, Ringwood, Victoria, Australia.                  energy to heat, for example, shortwave diathermy, mi-
Supported by the Australasian Cochrane Centre, Monash Institute of
Health Services Research, Monash University, Australia.                     crowave diathermy, and ultrasound.16 Superficial heat
This systematic review was originally published in The Cochrane Li-         includes such methods as hot water bottles, heated
brary and we acknowledge John Wiley & Sons Ltd., on behalf of the           stones, soft heated packs filled with grain, poultices, hot
Cochrane Collaboration, for authorizing this re-publication (French
SD, Cameron M, Walker BF, Reggars JW, Esterman AJ. Superficial              towels, hot baths, saunas, steam, heat wraps, heat pads,
heat or cold for low back pain. The Cochrane Database of Systematic         electric heat pads, and infra-red heat lamps. Cold ther-
Reviews 2006, Issue 1, Copyright Cochrane Library, reproduced with          apy is used to reduce inflammation, pain, and edema.
permission).
The device(s)/drug(s) is/are FDA-approved or approved by correspond-        Superficial cold includes cryotherapy, ice, cold towels,
ing national agency for this indication.                                    cold gel packs, ice packs, and ice massage.
No funds were received in support of this work. No benefits in any
form have been or will be received from a commercial party related
                                                                               Various national guidelines for the management of low
directly or indirectly to the subject of this manuscript.                   back pain have conflicting recommendation for heat and
There is consensus among the Editorial Board of the Back Review             cold therapy. The U.S. Agency for Healthcare Research and
Group that strong evidence can only be provided by multiple higher
quality trials that replicate findings of other researchers in other set-
                                                                            Quality guidelines found no evidence of benefit from the
tings.                                                                      application of ice or heat for acute low back pain, however,
Address correspondence and reprint requests to Simon D. French,             recommended self-application of heat or cold for patients
MPH, Australasian Cochrane Centre, Monash Institute of Health Ser-
vices Research, Locked Bag 29, Monash Medical Centre, Clayton,              to provide temporary relief of symptoms.17 Other guide-
Victoria, Australia; E-mail: simon.french@med.monash.edu.au                 lines give different recommendations.18 –21

998
Superficial Heat or Cold for LBP • French et al 999

Objectives. The objective of this review was to determine the        databases were adapted accordingly. We also screened references
efficacy of superficial hot or cold therapies in reducing pain and   of identified articles.
disability in low back pain in adults, aged 18 and older.
                                                                     Methods of the Review
Criteria for Considering Studies for This Review                         Selection of Studies. One author (S.D.F.) conducted the
   Types of Studies. We included randomized controlled trials        searches and compiled all of the abstracts retrieved by the
(RCTs) and nonrandomized controlled clinical trials (CCTs)           above search strategy. Two authors (S.D.F., B.F.W.) then inde-
comparing superficial hot or cold therapy to placebo, no ther-       pendently applied the inclusion criteria to all of these abstracts.
apy, or to other therapies.                                          If the eligibility of the study was not clear from the abstract,
                                                                     then the full text of the article was obtained and assessed inde-
   Types of Participants. Studies were selected that included        pendently by the two authors. Any disagreement between the
participants 18 years of age or older, with the complaint of         authors was resolved by discussion and consensus.
nonspecific low back pain. Trials that included participants
with pathologic causes of low back pain and low back pain               Data Extraction and Management. Two authors (S.D.F. and
with radiculopathy were excluded. For the purpose of this re-        M.C.) independently extracted the data onto a standard form.
view, the duration of back pain was defined as acute (⬍6             The data extraction form was pilot tested on one trial to min-
weeks), subacute (6 –12 weeks), or chronic (⬎12 weeks), as           imize misinterpretation. Any disagreement between the au-
defined by the Cochrane Back Review Group.22                         thors was resolved by discussion and consensus. We requested
                                                                     additional study details and data from trial authors when the
    Types of Interventions. Trials were included in which super-     data reported were incomplete. Some data from the Nadler
ficial heat or cold therapy was administered to at least one         studies23–25 and from the Mayer study26 were received from
group within the trial. Trials in which cointerventions (e.g.,       the authors and were incorporated into the table of included
exercise) were given were only included if the cointerventions       studies (Table 2) and the results.
were similar across comparison groups. If cointerventions were
given, trials were excluded if we could not isolate the effects of
                                                                     Assessment of Methodologic Quality of Included Studies.
heat or cold from the effects of the other therapies delivered.
                                                                     The methodologic quality of the included trials was independently
Trials of spa therapy (balneotherapy) were excluded because
                                                                     assessed by two authors (S.D.F., M.C.) and checked by a third
that intervention is being assessed by another Cochrane review.
                                                                     author (J.W.R.). The assessment of methodologic quality was per-
At the time of publication of our review, the protocol for the
                                                                     formed according to the methodologic criteria list recommended
balneotherapy review had only proceeded to the editorial re-
                                                                     by the Cochrane Back Review Group22 and scored as a “yes (Y)”,
view stage.
                                                                     “no (N),” or “don’t know (DK).” There were 11 criteria relevant
    Types of Outcome Measures. Trials were included that used        to the internal validity of the study, against which each trial was
at least one of the five outcomes considered to be important in      assessed, including selection bias, performance bias, attrition bias,
low back pain research: pain (e.g., measured by visual analogue      and detection bias. The methodologic quality assessment of the
scale), disability/function (e.g., measured by Oswestry, Roland      trials was used to grade the strength of the evidence. Higher-
Disability Scale), overall improvement, patient satisfaction,        quality trials were defined as fulfilling 6 or more of the 11 meth-
and adverse effects. The primary outcomes for this review were       odologic quality criteria. Lower-quality trials were defined as ful-
pain and physical functional status. Some included trials mea-       filling fewer than 6 criteria.
sured other outcomes, e.g., trunk flexibility or skin tempera-
ture; however, these results are not included in the analysis        Data Analysis. Only a small proportion of the data in the
because they are out of the scope of this review.                    included trials were available for pooling. For the majority of
                                                                     comparisons and outcomes, it was not possible to pool results.
                                                                     A qualitative method recommended by the Cochrane Back Re-
Search Strategy for Identification of Studies
                                                                     view Group22 using Levels of Evidence for data synthesis was
   Data Sources. The following sources were accessed and             performed:
searched:
                                                                        ●   Strong evidence1: consistent findings among multiple
   1. The Cochrane Controlled Trials Register (CENTRAL)                     high-quality RCTs
      (Cochrane Library Issue 3, 2005)                                  ●   Moderate evidence: consistent findings among multiple
   2. MEDLINE (1966 to October 2005)                                        low-quality RCTs or CCTs and/or one high-quality RCT
   3. EMBASE (1980 to October 2005)                                     ●   Limited evidence: one low-quality RCT and/or CCT
   4. CINAHL (1982 to October 2005)                                     ●   Conflicting evidence: inconsistent findings among multi-
   5. PEDro (Physiotherapy Evidence Database: www.                          ple trials (RCTs and/or CCTs)
      pedro.fhs.usyd.edu.au, accessed October 2005)                     ●   No evidence from trials: no RCTs or CCTs
   6. Cochrane Back Review Group Specialized register (May
      2005)                                                          Clinical Relevance. Two authors (S.D.F., J.W.R.) indepen-
   7. SPORTDiscus (1830 to October 2005)                             dently judged the clinical relevance of each trial, using the five
   8. OLDMEDLINE (1950 to 1965, searched October 2005)               questions recommended by the Cochrane Back Review
                                                                     Group,22 and scored each one as a yes, no, or don’t know:
  Search Strategy. The search strategy was based on that rec-
ommended by the Cochrane Back Review Group.22                           1. Are the patients described in detail so that you can decide
  The search strategies for CENTRAL, MEDLINE, and EM-                      whether they are comparable to those that you see in
BASE are seen in Table 1. Search strategies for the remaining              your practice?
1000 Spine • Volume 31 • Number 9 • 2006

Table 1. Search Strategies for OVID
MEDLINE                                                                    EMBASE                                          CENTRAL

 1.   randomized controlled trial.pt.                 1.   clinical article/                               1. BACK PAIN explode all trees (MeSH)
 2.   controlled clinical trial.pt                    2.   clinical study/                                 2. back pain or backache or lumbago
 3.   Randomized Controlled Trials/                   3.   clinical trial/                                 3. #1 or #2
 4.   Random Allocation/                              4.   controlled study/                               4. CRYOTHERAPY explode all trees (MeSH)
 5.   Double-Blind Method/                            5.   randomized controlled trial/                    5. cryotherapy or ice or cool or cold
 6.   Single-Blind Method/                            6.   major clinical study/                           6. heat* or hot or warm* or infrared or
                                                                                                              infra-red or poultice or spa* or sauna*
                                                                                                              or shower* or steam*
 7. or/1–6                                            7.   double blind procedure/                         7. #4 or #5 or #6
 8. Animal/not Human/                                 8.   multicenter study/                              8. #3 and #7
 9. 7 not 8                                           9.   single blind procedure/
10. clinical trial.pt.                               10.   crossover procedure/
11. exp Clinical Trials/                             11.   placebo/
12. (clin$ adj25 trial$).tw.                         12.   Or/1–11
13. ((singl$ or doubl$ or trebl$ or tripl$) adj25    13.   allocat$.ti,ab
   (blind$ or mask$)).tw.
14. Placebos/                                        14.   assign$.ti,ab
15. placebo$.tw.                                     15.   blind$.ti,ab
16. random$.tw.                                      16.   (clinic$ adj25 (study or trial)).ti,ab
17. Research Design/                                 17.   compare$.ti,ab
18. (latin adj square).tw.                           18.   control$.ti,ab
19. or/10–18 1                                       19.   cross?over.ti,ab
20. 9 not 8                                          20.   factorial$.ti,ab
21. 20 not 9                                         21.   follow?up.ti,ab
22. Comparative Study/                               22.   placebo$.ti,ab
23. exp Evaluation Studies/                          23.   prospectiv$.ti,ab
24. Follow-Up Studies/                               24.   random$.ti,ab
25. Prospective Studies/                             25.   ((singl$ or doubl$ or trebl$ or tripl$) adj25
                                                           (blind$ or mask$)).ti,ab
26.   (control$ or prospective$ or Volunteer$).tw.   26.   trial.ti,ab
27.   Cross-Over Studies/                            27.   (vs. or vs).ti,ab
28.   or/22–27                                       28.   Or/13–27
29.   28 not 8                                       29.   12 or 28
30.   29 not (9 or 21)                               30.   human/
31.   9 or 21 or 30                                  31.   nonhuman/
32.   low back pain/                                 32.   animal/
33.   low back pain.tw.                              33.   animal experiment/
34.   backache.tw.                                   34.   31 or 32 or 33
35.   lumbago.tw.                                    35.   30 and 34
36.   or/32–35                                       36.   29 not 34
37.   31 and 36                                      37.   29 and 35
38.   (heat$ or hot or warm$).tw.                    38.   36 or 37
39.   (infrared or infra-red).tw.                    39.   low back pain/
40.   poultice.tw.                                   40.   back pain.tw
41.   (spa$ or sauna$ or shower$ orsteam$).tw.       41.   backache.tw
42.   Cryotherapy/                                   42.   lumbago.tw
43.   (cryotherapy or ice or cool or cold).tw.       43.   Or/39–42
44.   or/38–43                                       44.   (heat$ or hot or warm$).tw
45.   37 and 44                                      45.   (infrared or infra-red).tw
                                                     46.   poultice.tw
                                                     47.   (spa$ or sauna$ or shower$ or steam$).tw
                                                     48.   Cryotherapy/
                                                     49.   (cryotherapy or ice or cool or cold).tw
                                                     50.   Or/44–49
                                                     51.   38 and 43 and 50

      2. Are the interventions and treatment settings described                 able for inclusion. All nine trials were published in En-
         well enough so that you can provide the same for your                  glish. Only 4 of these trials had pain data in a form that
         patients?                                                              could be extracted and combined in a meta-analysis,23–26
      3. Were all clinically relevant outcomes measured and re-
                                                                                and this was only possible after obtaining further data
         ported?
      4. Is the size of the effect clinically important?                        from the authors of the studies. All of these trials exam-
      5. Are the likely treatment benefits worth the potential harms?           ined a heat wrap as the main intervention. One trial had
                                                                                pain data that could be extracted27; however, it was ab-
      Results
                                                                                solute pain data as compared with change in pain data
The search strategy identified 1,178 potentially eligible                       used in the other heat wrap trials. The remaining four
studies. Of these, 123 were retrieved in full text. We                          trials did not present data in a form that could be ex-
identified nine trials involving 1,117 participants suit-                       tracted for meta-analysis.28 –31 Despite attempts to con-
Superficial Heat or Cold for LBP • French et al 1001

Table 2. Characteristics of Included Studies
Study                     Participants and settings                          Interventions                             Outcomes                   Authors’ Conclusions

Landen28 (1967)    143 participants with mix of acute and    1. Hot packs: twice daily for 20 min, across     1. Pain: participant reported    Ice massage and hot packs
                     chronic LBP; gender and age, not           lumbosacral area (n ⫽ 59)                        change in symptoms:             seem equally effective in
                     described; 117 participants             2. Ice massage: twice daily with cubes of           minimal, moderate, or           the symptomatic relief of
                     completed follow-up; definite              ice across lumbosacral area until numb,          marked increase or              low back pain
                     diagnosis of disc herniation               usually 10–12 min (n ⫽ 58)                       decrease in pain, or no
                     excluded; setting: U.S. Army            Cointerventions: all participants also              change
                     General Hospital, Germany                  performed flexion exercises                   2. Length of hospitalization
                                                                                                              3. Muscular spasm: not
                                                                                                                 described how measured
                                                                                                              Timing of outcome
                                                                                                                 measures: time of
                                                                                                                 discharge
Mayer et al 26     100 participants (29 male, 71 female)     1. Heat wrap alone (ThermaCare Heat Wrap;        1. Functional improvement:       Combining continuous
  (2005)             with acute (⬎2 days, ⬍3 mo)                Procter and Gamble, Cincinnati, OH),             MTAP                            low-level heat wrap
                     nonspecific LBP without radiation          applied to lumbar area, 40 C for 8 hr per     2. Disability: Roland Morris       therapy with directional
                     below the knee and normal                  day for 5 consecutive days (n ⫽ 25)           3. Pain relief: 6-point verbal     preference-based
                     neurologic examination, no              2. McKenzie exercise alone (n ⫽ 25)                 rating scale                    exercise therapy offers
                     comorbidities; duration of pain not     3. Heat wrap plus McKenzie exercise              Timing of outcome                  distinct advantages over
                     reported; mean age, 31.2 yr; setting:      (n ⫽ 24)                                         measures: 2 days, 4 days        either therapy alone for
                     outpatient medical facilities in        4. Educational booklet. Participants were           and 7 days after                the treatment of acute
                     California                                 advised to closely follow the                    randomization                   low back pain
                                                                recommendations, except that they were
                                                                asked to refrain from performing specific
                                                                exercises for the low back, using heat or
                                                                cold modalities, and receiving spinal
                                                                manipulation (n ⫽ 26)
                                                             Cointerventions not allowed, except for
                                                                medication as required
Melzack et al 29   44 participants (23 male, 21 female)      1. Ice massage: ice cube gently massaged         1. Pain: McGill pain             Ice massage is an effective
  (1980)             with chronic LBP, unresponsive to          on skin for a max 7 min at 3 sites (midline      questionnaire; measured         therapeutic tool and is
                     conventional care; mean duration of        low back, lateral malleolus, and popliteal       immediately after               more effective than TES
                     pain 7.4 yr; age, 18–73 yr                 space) with 3 min between applications,          treatment sessions              for some patients
                   Majority of participants had                 total treatment time of 30 min; ice           2. Preferred treatment
                     undergone previous surgery                 massage was administered by a                 Timing of outcome
                   Exclusion criteria: severe emotional         “technician”                                     measures: pain measured
                     problems as determined by               2. TES: 2 treatments of TES at the same 3           before and after each
                     Minnesota Multiphasic Personality          sites and time interval for 30 min;              treatment session, then
                     Inventory; setting: Pain centre,           interventions were administered on 2             1–12 mo after completing
                     Canada                                     occasions at 1- to 2-wk intervals                treatment
                                                             Treatment for each group was reversed
                                                                after the initial 2 treatment sessions with
                                                                a further 2 treatments of the alternate
                                                                intervention
                                                             Cointerventions not reported
Nadler et al 23    371 participants (155 male, 216 female)   1. Heat wrap (ThermaCare Heat Wrap;              1. Pain: 6-point verbal scale    Continuous low-level
  (2002)             with acute (⬍3 mo) nonspecific             Procter and Gamble, Cincinnati, OH) for          of pain relief                  topical heat wrap
                     LBP without radiation below the            approximately 8 hr per day (n ⫽ 113)          2. Muscle stiffness:               therapy is superior to
                     knee and normal neurologic              2. Oral ibuprofen: 2 tablets 3 times daily for      101-point scale                 both acetaminophen and
                     examination, no comorbidities;             a total dose of 1,200 mg, plus oral           3. Disability: Roland-Morris       ibuprofen
                     duration of pain not reported; mean        placebo 1 time daily (n ⫽ 106)                   (0–24 scale)
                     age, 36.0 yr; setting: clinical         3. Oral acetaminophen: 2 tablets 4 times         4. Lateral trunk flexibility
                     research sites                             daily for a total of 4,000-mg dose            5. Adverse effects
                                                                (n ⫽ 113)                                     Timing of outcome
                                                             4. Oral placebo: 2 tablets 4 times daily            measures: pain relief and
                                                                (n ⫽ 20)                                         disability measured daily
                                                             5. Unheated back wrap: (n ⫽ 19)                     for 4 days
                                                             Cointerventions not allowed                         post-randomization
Nadler et al 24    219 participants (100 male, 119 female)   1. Heat wrap (ThermaCare Heat Wrap;              1. Pain: 6-point verbal scale    Continuous low-level heat
  (2003)             with acute (⬍3 mo) nonspecific             Procter and Gamble, Cincinnati, OH) for 3        of pain relief                  wrap therapy was shown
                     LBP without radiation below the            consecutive days, approximately 8 hr per      2. Muscle stiffness:               to provide significant
                     knee and normal neurologic                 day (n ⫽ 95)                                     101-point scale                 therapeutic benefits in
                     examination, no comorbidities;          2. Oral placebo: 2 tablets, 3 times daily,       3. Disability: Roland-Morris       patients with acute
                     duration of pain not reported; mean        spaced 6 hr apart (n ⫽ 96)                       (0–24)                          nonspecific LBP
                     age, 36.1 yr; setting: clinical         3. Oral ibuprofen: 200 mg, 2 tablets, 3 times    4. Lateral trunk flexibility     No serious or significant
                     research sites                             daily, spaced 6 hr apart (n ⫽ 12)             5. Skin quality: 4-point scale     adverse effects were
                                                             4. Unheated wrap: (n ⫽ 16)                       Timing of outcome                  observed during the use
                                                             Cointerventions not allowed                         measures: pain relief and       of the heat wrap
                                                                                                                 disability measured daily
                                                                                                                 for 4 days post-
                                                                                                                 randomization
                                                                                                                                                               (Continued)
1002 Spine • Volume 31 • Number 9 • 2006

Table 2. (Continued)
Study                      Participants and settings                          Interventions                            Outcomes                   Authors’ Conclusions

Nadler et al 25     76 participants (27 male, 49 female)      1. Heat wrap (ThermaCare Heat Wrap;             1. Pain relief: 6-point verbal   Continuous low-level heat
  (2003)              with acute (⬍3 mo) nonspecific             Procter and Gamble, Cincinnati, OH) worn        rating scale                    wrap therapy was shown
                      LBP without radiation below the            during sleep for approximately 8 hr each     2. Muscle stiffness:               to provide effective
                      knee and normal neurologic                 night for 3 consecutive nights (n ⫽ 33)         101-point numeric rating        daytime pain relief after
                      examination, no comorbidities;          2. Oral placebo: 2 tablets before bed each         scale                           overnight use in subjects
                      duration of pain not reported; mean        night for 3 consecutive nights (n ⫽ 34)      3. Pain effect: 101-point          with acute nonspecific
                      age, 41.4 yr; setting: clinical         3. Oral ibuprofen: 2 tablets; total dose, 400      numeric rating scale            LBP
                      research sites                             mg, before bed each night for 3              4. Disability: Roland-Morris     The heat wrap showed a
                                                                 consecutive nights (n ⫽ 4)                      (0–24)                          good safety profile when
                                                              4. Unheated wrap worn during sleep for          5. Lateral trunk flexibility       worn during sleep
                                                                 approximately 8 hr each night for 3          6. Subjective measures of
                                                                 consecutive nights (n ⫽ 5)                      sleep quality and
                                                              Cointerventions not allowed                        difficulty in sleep onset:
                                                                                                                 6-point scale
                                                                                                              Timing of outcome
                                                                                                                 measures: days 1–4 after
                                                                                                                 commencement of
                                                                                                                 treatment
Nuhr et al 27       90 participants (57 male, 33 female)      1. Resistive heating of 42 C via a carbon-      1. Pain: 100 point VAS           Local active warming is an
  (2004)              with first episode acute (⬍ 6 hr)          fiber electric heating blanket (ThermaMed    2. Tympanic thermocouple           effective and easy-to-
                      LBP without radiation below the            GmbH, Bad Oeynhausen, Germany)                  (core temperature)              learn emergency care
                      knee and normal neurologic                 covered by a single woolen blanket; the      3. Skin thermosensors and          treatment for acute low
                      examination, no comorbidities;             active heating component covered an             intracutaneous                  back pain that could be
                      mean age, 36.8 yr (⫾8.2 yr); setting:      area of 148 ⫻ 40 cm; mean duration of           thermosensors                   used by emergency
                      emergency site in Austria                  treatment, 24.8 ⫾ 8.1 min                    4. Adverse effects: all            physicians as well as by
                                                                 (n ⫽ 47)                                        measurements were               paramedical personnel
                                                              2. Passive warming: single woolen blanket;         recorded by the same
                                                                 mean duration of treatment, 26.2 ⫾ 9.3          independent investigator
                                                                 min (n ⫽ 43)                                    blinded to the treatment
                                                              Cointerventions not allowed                        with the electrical
                                                                                                                 blanket, which he/she
                                                                                                                 was forbidden to touch
                                                                                                              Timing of outcome
                                                                                                                 measures: all measured
                                                                                                                 at arrival to hospital
Roberts et al 30    36 participants (17 male, 19 female),     1. Hot pack (160 F) with 6–8 layers of towels   1. Pain: VAS (0–20)              Ice massage was found to
  (1992)              with chronic low back pain; mean           for 20 min                                      immediately after and 1         be significantly more
                      duration of pain, 4.6 yr; age, 24–72    2. Cold packs (0 F) with 2 layers damp             hr after intervention           effective than either hot
                      yr (mean, 40.4 yr); all participants       towels for 20 min                                                               packs or cold packs for
                      had failed to respond to traditional    3. Ice massage: lightly rubbing low-back                                           relief of chronic low
                      medical management; setting: Pain          with cake of ice 4.2 ⫻ 2 ⫻ 4.5 inches;                                          back pain
                      centre, United States                      over 2-wk period, each participant was
                                                                 given two applications with each of the
                                                                 three interventions; cointerventions:
                                                                 during study all participants were
                                                                 participating in a comprehensive pain
                                                                 rehabilitation program, including
                                                                 medication
St. John            38 participants (12 male, 24 female)      1. Medima angora wool body belt (“giving        1. Preference for type of        The findings of this study
   Dixon et al 31     with chronic nonspecific low back          insulation and warmth without support”)         support                         call into question the
   (1972)             pain; mean duration of pain, 17 yr      2. Reemploy “instant” lumbosacral corset        2. Pain (but no data               common practice of
                      (range, 0.5–40 yr); age, 30–80 yr          (“giving support but little insulation”)        reported)                       prescribing a
                      (mean, 61 yr) setting: orthopedic       3. Participants instructed to wear each         3. Adverse effects: timing of      lumbosacral support for
                      outpatient department in United            intervention for 1 wk; cointerventions not      outcome measures: all           chronic, nonspecific, low
                      Kingdom                                    described                                       measured after 1 and            back pain; many patients
                                                                                                                 2 wk                            fare equally well with a
                                                                                                                                                 simple warm body belt

RCT ⫽ randomized controlled trial; CCT ⫽ controlled clinical trial; LBP ⫽ low back pain; NSAIDs ⫽ nonsteroidal anti-inflammatory drugs; VAS ⫽ visual analogue
scale; MTAP ⫽ Multidimensional Task Ability Profile; TES ⫽ transcutaneous electrical stimulation.

tact all authors, only additional data for the three Nadler                             participants,23–26 three included chronic low back pain
trials and the Mayer trial were obtained.                                               participants,29 –31 and one had a mix of acute, subacute,
   Included Studies                                                                     and chronic participants.28
Table 1 shows characteristics of included studies. The                                     The nature of the interventions differed between the tri-
median number of participants in each trial was 90                                      als. Two trials compared hot packs to ice massage,28,30 one
(range, 36 –371). According to our definition, one of the                               trial compared ice massage to transcutaneous electrical
trials included acute low back pain participants,27 four                                stimulation,29 one trial compared a full body active warm-
included a mix of acute and subacute low back pain                                      ing electric blanket to passive warming by way of a wool
Superficial Heat or Cold for LBP • French et al 1003

Table 3. Methodologic Quality Assessment of Included Trials
                                                                                                                                      Summary Scores and
Study                               A        B         C       D       E        F        G         H         I        J       K           Comments

Landen28 (1967)                    N         N        DK       N       N       N         DK       Y        Y         DK       N          Score ⫽ 2 (low)
Mayer et al 26 (2005)              Y         DK       Y        N       N       DK        Y        Y        Y         Y        N          Score ⫽ 6 (high)
Melzack et al 29 (1980)            N         N        DK       N       N       DK        Y        N        DK        Y        N          Score ⫽ 2 (low)
Nadler et al 23 (2002)             DK        DK       Y        N       N       Y         Y        DK       Y         Y        Y          Score ⫽ 6 (high)
Nadler et al 24 (2003)             DK        DK       Y        N       N       Y         Y        DK       Y         Y        Y          Score ⫽ 6 (high)
Nadler et al 25 (2003)             DK        DK       Y        N       N       Y         Y        DK       Y         Y        Y          Score ⫽ 6 (high)
Nuhr et al 27 (2004)               Y         Y        Y        N       N       Y         Y        Y        Y         Y        N          Score ⫽ 8 (high)
Roberts et al 30 (1992)            N         N        DK       N       N       N         DK       DK       DK        Y        N          Score ⫽ 1 (low)
St. John Dixon et al 31 (1972)     DK        N        DK       N       N       N         DK       DK       Y         Y        N          Score ⫽ 2 (low)
Y ⫽ yes; N ⫽ no; DK ⫽ don’t know.
A ⫽ Was the method of randomization adequate? B ⫽ Was the treatment allocation concealed? C ⫽ Were the groups similar at baseline regarding the most
important prognostic indicators? D ⫽ Was the patient blinded to the intervention? E ⫽ Was the care provider blinded to the intervention? F ⫽ Was the outcome
assessor blinded to the intervention? G ⫽ Were co-interventions avoided or similar? H ⫽ Was the compliance acceptable in all groups? I ⫽ Was the dropout rate
described and acceptable? J ⫽ Was the timing of the outcome assessment in all groups similar? K ⫽ Did the analysis include an intention-to-treat analysis?

blanket,27 and one trial compared a wool body belt that                             Methodologic Quality of Included Studies
provided warmth to a lumbar corset.31                                            The included trials were of varying methodologic quality
   Four trials assessed the effect of a disposable heated                        (Table 3). Applying the criteria of six or more equalling a
lumbar wrap (ThermaCare Heat Wrap; Procter and                                   high-quality study, five of the trials were of high quality
Gamble, Cincinnati, OH) compared with various inter-                             (range, 6 – 8) and four low quality (range, 1–5). Five of
ventions. Three of these trials compared the heated wrap                         the trials were reported as randomized.23–27 In the Nadler
with pain relief medication and with a nonheated                                 series of trials, the method of randomization was not
wrap,23–25 and one trial compared the heated wrap alone                          described. One trial was a nonrandomized CCT28 and
with exercise alone, with heat plus exercise, and with an                        three were nonrandomized crossover trials.29 –31 Wash-
educational booklet.26 The heat wrap is a disposable                             out of the interventions was not considered in any of the
                                                                                 crossover trials. Trial population sizes were generally
product made of layers of cloth-like material that con-
                                                                                 small (median sample size, 90; range, 36 –371). Five of
tain heat-generating ingredients (iron, charcoal, table
                                                                                 the trials reported clear inclusion and exclusion crite-
salt, and water). These ingredients heat up when exposed
                                                                                 ria,23–27 two trials reported brief inclusion and exclusion
to oxygen and provide heat (40 C) for at least 8 hours.
                                                                                 criteria,28,29 and two trials did not state exclusion crite-
The heat wrap is applied to the lumbar region of the                             ria.30,31 Allocation concealment was adequate in only
torso and is secured with a Velcro-like closure, thus al-                        one of the trials,27 and in the remaining trials was either
lowing it to be worn while remaining mobile. It can be                           not reported or was inadequate. Blinded outcome assess-
worn during the day or night. The single use heat wrap                           ment was carried out in four trials23–25,27 and was either
costs approximately U.S. $6.00 to $8.00 for a packet                             not done or was unclear in the remaining five trials.
of two.                                                                          Blinding of participants to the interventions of heat or
   The outcomes assessed and the timing of outcomes                              cold was not possible in most cases. Most trials had an
varied. Pain was assessed in all trials, however, for only                       acceptable loss to follow-up; however, only three of the
five trials were pain data available for meta-analysis.                          trials reported if an intention-to-treat analysis was un-
Three trials only measured pain immediately after the                            dertaken.23–25
treatment,27,29,30 four trials measured pain over 4 to 7
                                                                                    Comparison 1: Heated Wrap Versus Oral Placebo
days,23–26 one trial measured pain at the time of hospital
                                                                                    or Nonheated Wrap
discharge,28 and one after 2 weeks.31 A validated disabil-
                                                                                 Four higher-quality trials assessed a heated wrap or
ity measure was used in four trials.23–26 None of the
                                                                                 heated blanket versus either an oral placebo tablet, or a
trials assessed overall improvement or participant satis-                        nonheated wrap23–25,27 in participants with a mix of
faction.                                                                         acute and subacute (⬍3 months) low back pain. It was
   Four of the trials declared industry funding.23–26 The                        only possible to combine the data from a maximum of
three Nadler trials were all conducted by the same re-                           two trials.
search team and were funded by the manufacturer of the                              Pain relief data were extracted from two of the trials
heat wrap device. The authors of each of these trials were                       with 258 participants that compared a heated wrap to
either employees or paid consultants of the company that                         oral placebo.24,25 The short-term pain relief was signifi-
manufactures the heat wrap device. Correspondence                                cantly greater for the heated back wrap than for the oral
from the authors indicated that these three trials are                           placebo (weighted mean difference [WMD], 1.06; 95%
completely separate studies with each of them including                          confidence interval [CI], 0.68 to 1.45 scale; range, 0 –5).
different participants.                                                          Pain relief was only measured for up to 5 days after
1004 Spine • Volume 31 • Number 9 • 2006

randomization. This result indicates an approximate             One high-quality trial of 100 participants compared a
17% reduction in pain after 5 days with a heated back        heated back wrap alone with exercise alone and with an
wrap compared with oral placebo. Pain data measuring         education booklet.26 Measured at 1 and 4 days after
the degree of “unpleasantness” were only available for       randomization, the heat wrap provided significantly
one trial25 and indicated a significant decrease in the      more pain relief than an educational booklet (day 2:
short-term (WMD, ⫺13.50; 95% CI, ⫺21.27 to ⫺5.73;            WMD, 0.60; 95% CI, 0.05 to 1.15; scale range, 0 –5; day
scale range, 0 –100).                                        4: WMD, 1.10; 95% CI, 0.55 to 1.65) but not more than
   Absolute pain data were only available in one trial of    McKenzie exercise (day 2: WMD, 0.40; 95% CI, ⫺1.15
90 participants.27 This trial demonstrated a statistically   to 0.95; day 4: WMD, 0.30; 95% CI, ⫺0.41 to 1.01). At
significant benefit of a heated blanket compared with a      7 days after randomization, there were no significant
nonheated blanket immediately after treatment in acute       differences in pain relief between the groups. The heat
(⬍6 hours) low back pain (WMD, ⫺32.20; 95% CI,               wrap provided significantly improved function com-
⫺38.69 to ⫺25.71; scale range, 0 –100). Pain was only        pared with an educational booklet at day 2 (WMD,
measured immediately after the heat was applied for ap-      ⫺1.40; 95% CI, ⫺2.79 to ⫺0.01; scale range, 0 –24) and
proximately 25 minutes, and no further follow-up oc-         day 4 (WMD, ⫺2.30; 95% CI, ⫺4.24 to ⫺0.36) but not
curred.                                                      at day 7 (WMD, ⫺1.70; 95% CI, ⫺3.92 to 0.52). There
   Only two trials provided data on disability,24,25 mea-    was no significant difference in function between heat
sured with the Roland-Morris Disability Questionnaire.       wrap and McKenzie exercise at day 2, day 4, or day 7.
The short-term (4 days) reduction in disability was sig-        One lower-quality nonrandomized crossover trial
nificantly greater for the heated back wrap than for oral    compared a wool body belt providing warmth to a lum-
placebo (WMD, ⫺2.10; 95% CI, ⫺3.19 to ⫺1.01; scale           bar corset in chronic low back pain participants.31 No
range, 0 –24).                                               pain results were provided.
   Adverse effects were minor for the heated back wrap.
Two trials provided data on the adverse effect of “skin         Comparison 5: Cold Versus Other Interventions
pinkness” after use of the heated wrap.24,25 A total of 6    Only one low-quality nonrandomized crossover trial ex-
of 128 participants experienced this outcome in the          amined this comparison.29 This trial compared ice mas-
heated back wrap group, compared with 1 participant          sage with transcutaneous electrical stimulation (TES) in
out of 130 in the placebo group.                             chronic low back pain participants. The trial concluded
   No trials were located that examined this comparison      that ice massage and TES were equally effective in reduc-
for chronic low back pain or for the medium- or long-        ing pain.
term effects of this intervention.                               Comparison 6: Heat Plus Exercise Versus
                                                                 Other Interventions
  Comparison 2: Cold Versus Placebo or No Cold               One higher-quality trial of 100 participants combined a
No studies were located that examined this comparison.       heated back wrap with exercise and compared this to
                                                             heat alone, exercise alone, and to an educational book-
   Comparison 3: Heat Versus Cold                            let, in participants with a mix of subacute and acute low
Two lower-quality trials evaluated heat versus cold in       back pain.26 Heat wrap plus exercise provided signifi-
the form of hot packs versus ice massage.28,30 Unfortu-      cantly more pain relief than an educational booklet at
nately, there were very little data available in either of   day 4 (WMD, 1.60; 95% CI, 0.89 to 2.31; scale range,
these trials to extract. Both of these trials were nonran-   0 –5) and day 7 (WMD, 2.00; 95% CI, 1.29 to 2.71), and
domized: one a controlled trial28 and the other a cross-     also for function (Roland Morris) (day 4: WMD, ⫺2.60;
over trial.30 One trial concluded that hot packs and ice     95% CI, ⫺4.54 to ⫺0.66; day 7: WMD, ⫺4.40; 95% CI,
massage were not significantly different for participants    ⫺6.62 to ⫺2.18). Heat wrap plus exercise also provided
with a mix of acute, subacute, and chronic low back          significantly more pain relief and improvement in func-
pain. The other concluded that ice massage was superior      tion than either heat or exercise alone at day 7. This
to hot packs in participants with chronic low back pain.     improvement in pain and function was not evident at the
                                                             earlier time periods measured (day 2 or day 4).
   Comparison 4: Heat Versus Other Interventions
Three higher-quality trials compared a heated back wrap         Clinical Relevance
with oral ibuprofen,23–25 and one of these trials also       The median score for the trials was 3 of 5. The higher-
included a comparison group that took oral acetamino-        quality trials generally had a higher clinical relevance
phen.23 Unfortunately, none of these trials presented        score.
data in a way that could be combined in a meta-analysis.
                                                               Discussion
One trial23 found that a heated back wrap provided sig-
nificantly greater pain relief and improved function than    Only a few studies have been published evaluating the
oral ibuprofen and oral acetaminophen after both 1 day       effects of superficial heat or cold for low back pain. We
and 4 days of treatment. The other two Nadler trials did     found nine trials involving 1,117 participants that were
not provide results for this comparison.                     suitable for inclusion in this review. Of these, six trials
Superficial Heat or Cold for LBP • French et al 1005

examined heat compared with no heat or other interven-         to these interventions. The Nadler series of studies23–25
tions, one compared cold to another intervention, and          and the Nuhr study27 attempted to blind participants by
two trials compared heat to cold. The included trials          including a nonheated wrap or blanket and an oral pla-
were very heterogeneous in terms of interventions used,        cebo group; however, the investigators did not measure
control treatments, outcome measures, timing of follow-        whether participants could determine if they were receiv-
up, and presentation of data. Therefore, it was not pos-       ing an active therapy or not. Also, outcome assessors
sible to perform any meaningful meta-analyses, and it          should be blinded to the allocation of the participants to
was difficult to reach firm conclusions for most types of      at least improve the quality of this aspect of the trials. It
treatments.                                                    is recommended that these methodologic issues are con-
   According to the qualitative criteria for levels of evi-    sidered in future trials.
dence, for a mixed population with acute and subacute              Heat and cold are methods that are commonly used in
low back pain, there is moderate evidence that a heated        practice in conjunction with other interventions, espe-
wrap applied for 8 hours, or an electric blanket applied       cially in the physical therapy professions. We only found
for 25 minutes, are both better than no heat for pain in       one small study that evaluated the use of heat combined
the short-term (4 days). There is moderate evidence (one       with exercise, and we found no study that examined cold
small high-quality RCT) that heat wrap is better for pain      in this context. Thus, no conclusions can be drawn re-
and function than an educational booklet during the            garding the use of heat or cold in combination with other
early stages of treatment (days 2– 4), but not after 7 days.   therapies, other than in combination with exercise.
There is moderate evidence that combining heat wrap
with McKenzie exercises is better for pain relief and
                                                                  Conclusion
function after 7 days than an educational booklet and
either heat wrap or exercise alone. The effect of these           Implications for Practice
treatments was small. If the short-term beneficial effects     Heat and cold are commonly recommended by clinicians
of this therapy can be verified in further high-quality        for low back pain. The evidence base to support this
trials, then its use would be valuable.                        common practice is not strong. There is moderate evi-
   There is empirical data that indicate that industry-        dence that continuous heat wrap therapy reduces pain
funded studies are more likely to be positive than non-        and disability in the short-term, in a mixed population
funded studies.32–34 The results of the Nadler series of       with acute and subacute low back pain (up to 3 months)
studies and the Mayer study of heat wrap therapy should        and that the addition of exercise to heat wrap therapy
be considered with this in mind, and independent studies       further reduces pain and improves function. This evi-
would be useful to verify their results. Also, considering     dence is limited to a small number of trials using a rela-
the cost of the disposable heat wraps, it would be useful      tively small number of participants, and the size of the
to include a cost-effectiveness analysis in future trials.     effect is small. The application of cold treatment to low
   No RCTs were located that examined the effects of           back pain is even more limited, with only three poor-
cold for low back pain. Given that it is a commonly held       quality studies located. No conclusions can be drawn
belief that cold is beneficial for recent onset musculoskel-   about the use of cold for low back pain. There is conflict-
etal injuries,35 it was surprising that no studies were lo-    ing evidence to determine the differences between heat
cated that applied cold treatment to acute low back pain.      and cold for low back pain.
Indeed, in the trials conducted with participants with
acute and subacute low back pain, heat was applied. The           Implications for Research
trials that were located for cold treatment used cold for      Many of the studies were of poor methodologic quality,
chronic low back pain and were of poor methodologic            and there certainly is a need for future higher-quality
quality. No conclusions can be drawn for the use of cold       RCTs. Also, many trials were poorly reported, and we
treatment in low back pain.                                    recommend that authors use the CONSORT statement
   There is conflicting evidence when comparing heat           as a model for reporting RCTs (www.consort-
treatment to cold treatment. Two low-quality nonran-           statement.org). The results of the majority of the studies
domized trials of chronic low back pain participants           could not be pooled with other studies because of the
were located. One concluded that hot packs and cold            way the authors reported the results. Therefore, we sug-
packs were equally effective, and the other concluded          gest that the publications of future trials report, for con-
that ice massage was better than either hot packs or cold      tinuous measures, means with standard deviations or
packs.                                                         means with standard error of means, and for dichoto-
   There were no major adverse events reported in any of       mous measures, number of events and total participants
the trials. Some minor events were reported with the heat      analyzed.
wrap therapy, in the form of “skin pinkness” that re-             Future research should focus on areas where there are
solved quickly.                                                few or no trials, for example, simple heat applications
   There are methodologic challenges when conducting           like hot water bottles, ice massage versus no cold and
high-quality trials into these therapies. For example, it is   heat versus cold treatment, and trials in chronic low back
questionable whether or not participants can be blinded        pain participants. The classification of duration of low
1006 Spine • Volume 31 • Number 9 • 2006

back pain was not consistent in the different studies, and                        10. Jette DU, Jette AM. Physical therapy and health outcomes in patients with
                                                                                      spinal impairments. Phys Ther 1996;76:930 – 45.
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should be adequately powered and have both a short-
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                                                                                  18. New Zealand Guideline Group. Acute Low Back Pain Guide. Wellington,
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                                                                                      Management of Acute Nonspecific Low Back Pain in Primary Care. Avail-
   ● Nine trials involving 1,117 participants were in-                                able at: http://www.backpaineurope.org (accessed 22nd March 2005).
   cluded in this systematic review.                                              22. van Tulder M, Furlan A, Bombardier C, et al. Updated method guidelines for
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   ● There is moderate evidence that heat wrap ther-
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                                                                                      low back pain. Spine 2002;27:1012–7.
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                                                                                  24. Nadler SF, Steiner DJ, Erasala GN, et al. Continuous low-level heatwrap
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