A Research Protocol to Evaluate the Efficacy of Powerball versus Mulligan Mobilization with Movement on Pain and Function in Patients with Lateral ...
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Journal of Pharmaceutical Research International
33(45B): 491-500, 2021; Article no.JPRI.74474
ISSN: 2456-9119
(Past name: British Journal of Pharmaceutical Research, Past ISSN: 2231-2919,
NLM ID: 101631759)
A Research Protocol to Evaluate the Efficacy of
Powerball versus Mulligan Mobilization with
Movement on Pain and Function in Patients
with Lateral Epicondylitis
Shivani Uttamchandani1 and Pratik Phansopkar1*
1Department of Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy College, Datta
Meghe Institute of Medical Sciences, Sawangi Meghe, Wardha, India.
Authors’ contributions
This work was carried out in collaboration between both authors. The study's design was
recommended by author SU. The study was created and designed by authors SU and PP. This
article's draft was written by author SU. The final text was examined and authorized for publication by
authors SU and PP. Both authors read and approved the final manuscript.
Article Information
DOI: 10.9734/JPRI/2021/v33i45B32831
Editor(s):
(1) Dr. Francisco Cruz-Sosa, Metropolitan Autonomous University, México.
Reviewers:
(1) Yenew Alemu Mihret, Injibara University, Ethiopia.
(2) Sabah Abdellatif Hussein Ali Beza, Cairo University, Egypt.
Complete Peer review History: https://www.sdiarticle4.com/review-history/74474
Received 28 July 2021
Study Protocol Accepted 04 October 2021
Published 09 October 2021
ABSTRACT
Background: Amongst the most frequently repeated stress conditions within the elbow joint
includes lateral epicondylitis (LE). The extensor carpi radialis brevis muscle attachment is affected
mostly. The management of an individual with LE that manifests itself in repetitive upper extremity
motions is the purpose of this research. There seems to be no study on the effects of PowerBall
device training on the pain and function in individuals with Lateral Epicondylitis. “PowerBall device”
practice is a type of strength training.
Methods / Design: After conducting initial evaluations and allocation, the subjects (n=50) with LE
will be involved in a randomized controlled study and classified either in an intervention group or a
conventional group. The interventional group will do “PowerBall device” exercises, while others in
the control group, doing MMWM. These groups will receive basic movements and ultrasound in
accordance with the procedures.
_____________________________________________________________________________________________________
*Corresponding author: E-mail: drpratik77@gmail.com;Uttamchandani and Phansopkar; JPRI, 33(45B): 491-500, 2021; Article no.JPRI.74474
Discussion: The PRTEE scale measured the intervention's impact on pain and function in patients
with LE, and a Hand-held Dynamometer was utilized to quantify grip strength. The findings will give
considerable support for the use of the "PowerBall device" exercise and MMWM on LE patients.
Conclusion: Conclusion will be drawn post study so as to see whether PowerBall device is more
helpful or Mulligan Mobilization with Movement on pain and function in patients with LE. This study
will give better approach to the therapist in managing the condition.
Keywords: “PowerBall device”; MMWM; LE; extensor carpi radialis brevis muscle; pain & function;
grip strength.
ABBREVIATIONS Frequent upper - limb activities, such as
computer use, dominant forearm pronation and
MMWM : Mulligan mobilization with movement supination, lifting heavy, and repeated vibration,
LE : Lateral Epicondylitis are perhaps the most common causes in men
PRTEE: Patient Rated Tennis Elbow Evaluation and women [7]. Since this upper limb relies on
RCT : Randomised Control Trial peripheral muscles, ligaments, and capsules to
QOL : Quality Of Life direct action, it is frequently seen [8]. Despite its
AVBRH: Acharya Vinobha Bhave Rural Hospital name, commonly found in sports such as
OPD : Out-patient Department badminton, swimming, squash, baseball, and
IPD : In-patient Department throwing activities.
1. INTRODUCTION Although the typical presentation of LE are
obvious and simple to identify, no optimum
Amongst the most common arm lesions is treatment has yet been discovered. According to
Lateral Epicondylitis (LE), also known as Lateral evidence, corticosteroid injections are associated
Elbow Tendinopathy (LET) or Tennis Elbow [1]. with lower results in the intermediate and long-
Morris was the only one to coin the term "lawn term compared to controls [9]. Several more
tennis arm" in 1882 [2]. The word tendinopathy practitioners recommend for a conservative
refers to a collection of pathologies, comprising approach as the possible treatment for LE.
recurrent overuse tendon conditions. This Physiotherapy is a conservative treatment option
condition can affect the extensor tendons mostly for those who have LE. The exercise regimen for
on lateral side of the forearm which is most LE is the most common physical therapy
common in middle-aged people, with a highest rehabilitation. In general, an exercise program
incidence of 40 to 60 years [3]. consists of exercises conducted in a therapy
room as well as activities completed at home
It's usually a job or sports-related ailment [10].
characterized by extended, consistent, repetitive
eccentric contractions and wrist grasping. In the There is a higher frequency among individuals
normal community, a reported incidence of 1-3 engaged in high-risk sectors involving loading,
percent is found, with the dominant arm being frequent gripping, and/or wrist extension
the most commonly afflicted [4]. Whereas the activities, as well as racquet sports participants
name "tennis elbow" is misleading as tennis [11]. Extreme loading hastens the transition from
players account for just 5 to 10% of cases, racket healthy tendons to degenerative tendinosis,
sports involvement raises the risk of this issue irrespective of individual risk factors including
and therefore can trigger it in 40 to 50% of age, occupation, hobbies, or previous injury [12].
athletes [5].
In addition, the impact of resistance training on
Both men and women have similar rates of increasing shoulder and elbow muscular strength
incidence. Approximately 75% of the people is is being investigated, although eccentric
afflicted in their dominant arms, according to exercises have previously demonstrated some
studies. Diagnostically and therapeutically, the relief in the symptoms of tennis elbow [13].
extensor carpi radialis brevis muscle with Recent research has discovered that vibrating
episodic participation of the extensor digitorum instruments (PowerBall device) had a greater
communis, extensor carpi radialis longus, and influence on muscular strength, pain, ROM, and
extensor carpi ulnaris muscles is perhaps the health quality in patients with tennis elbow
most commonly pulled in muscle [6]. injuries than dumbbell exercise [14]. Throughout
492Uttamchandani and Phansopkar; JPRI, 33(45B): 491-500, 2021; Article no.JPRI.74474
the chronic stage, using a "PowerBall device" to 2. Between the ages of 20 and 50
impart extrinsic and intrinsic strain to the wrist, 3. Pain present on elbow’s lateral side
elbow, and shoulder muscles is believed 4. Tenderness persists on palpation over
beneficial resistance training [6]. the forearm extensor carpi radialis
tendon.
According to research, using the "PowerBall 5. Diagnosis confirmed on the basis of
gadget" resulted in enhanced power. Despite the physical test (Cozens Test, Mill’s Test,
fact that using a dynamic PowerBall has been Maudsley’s Test)
demonstrated to enhance strength, function,
range of motion, tennis elbow discomfort, and 2.3.2 Exclusion criteria are as follows:
quality of life in overhead sportsmen, the majority
of frequent concerns have yet to be validated 1. Fractures present around elbow
[15]. 2. Any old surgical history around elbow
Mulligan Mobilisation with movement (MMWM) is 3. Any previous pathology of bone around
a kind of manual treatment that integrates elbow.
continuous lateral glide with physiological elbow 4. Absence of clinical signs of tennis elbow.
mobility [16]. MMWM concentrates on mobilizing 5. Any underlying deformities (Increased
the joint during physiological movements, as carrying angle/ hyperextended elbow)
compared to conventional mobilisation 6. Steroid injection taken recently for LE
approaches that concentrate on mobilisation in a within 3 months.
static posture. According to studies, MMWM is 7. Any history of acute trauma
effective in reducing pain and improving the 8. Having neurological involvement.
functional capacity of elbow joints in LE patients 9. Any other systemic illness like metabolic,
[17]. metastatic, infective disorders.
1.1 Aim 2.4 Recruitment
The purpose of this research is to see how the
PowerBall Device, when compared to Mulligan The orthopaedician working under AVBRH
Mobilisation with Movement, affects pain and (DMIMSU) are invited to refer the prospective
function in patients with Lateral Epicondylitis. patients to our in-patient department (IPD).
Patients having Lateral Epicondylitis that are
2. METHODOLOGY currently undergoing physiotherapy in the IPD
will be carefully screened for research criteria.
2.1 Study Setting Once the study's eligibility requirements are
fulfilled, the participants are randomly assigned
Trial will be carried out in Ravi Nair to one of two groups. Approval from patients will
Physiotherapy College, Musculoskeletal OPD, indeed be accumulated before the allocation and
AVBRH Sawangi, Meghe, Wardha. after elaborating the purpose, nature, procedure,
2.2 Study Design and Sample Size prospective benefits and aftereffects of the
intervention.
The study design for patients who have been
diagnosed with Lateral Epicondylitis is a single- 2.5 Procedure
blinded RCT method. The total number of
subjects in this experimental study is 50 (n=50). 2.5.1 Participant Timeline
For three weeks, the participants would be
randomly assigned to one of the two groups: an Study duration is of 1 year and intervention
experimental group (Group A) and a duration is of 3 weeks so participants will be
conventional group (Group B). Goals and enrolled and three weeks of intervention will be
methods of the study will be informed to the completed successfully. Assessment will be done
Participants before being accepted, and written on 1st day of the visit and on the 21st day i.e.
patient consent form will be signed by them. completion or at the end of the intervention.
2.3 Participants 2.5.2 Implementation
2.3.1 Inclusion criteria are as follows:
Randomization will be supervised by the
1. All subjects having symptoms for more research coordinator and principal investigators.
than 2 weeks Participants will be asked to hand-pick a sealed
493Uttamchandani and Phansopkar; JPRI, 33(45B): 491-500, 2021; Article no.JPRI.74474
group allocation for the recruitment into either or her shoulder and the forearm of the sufferer,
group from the envelope. near to the elbow joint. While doing prolonged
lateral glides with the belt, the participants are
2.5.3 Blinding told to create a fist and release it without
Tester(s) will be blinded to assign the subjects to discomfort. In a single session, the therapist did
the group. To ensure binding, subjects will be the technique 30 times. After ten repeats, there
mandated not to reveal any details of their will be a one-minute rest time. Each session is
treatment to the tester. 30-60 minutes long. Mobilizations with movement
were conducted in three sets every session, five
sessions planned every week for the following
3. STUDY PROCEDURE
three weeks. The Exercise protocol of MMWM
The individuals, divided in two groups where which will be performed is present below in the
Group A would be the experimental group, and Table 2.
Group B will become the conventional group.
4. OUTCOME MEASURES
Prior to conducting Powerball exercises and
MMWM, both Groups will always get ultrasound 4.1 Primary Outcome Measure
[18] and the exercises [19]. Pulsed mode will be
used for Ultrasound at 1 w/cm 2 for 10 minutes 1. Patient-Rated Tennis Elbow Evaluation
using gel Binder on lateral epicondyle or at the (PRTEE)
site of tenderness [20,21].
Before and after therapy, the PRTEE score is
Exercises used in LE patients for pain and functional
impairment assessment. The PRTEE
i. Clenching the fist powerfully measure is segregated into two: pain and
ii. Resisted exercises to wrist flexor and functional impairment [22].
extensor muscles.
iii. Wrist pronation and supination. 2. Hand Dynamometer
iv. Stretching wrist flexors and extensors for 30
Grip strength is measured using Hand held
seconds at the end range
dynamometer, a special clinical tool to
determine and calculate the most intense
Each exercise written above will be performed in
isometric properties of the hand and forearm
3 series for 10 times.
muscles. Dynamometers are used to measure
hand strength in sports like baseball and
3.1 Group A (Experimental) tennis, where the hand is used for flipping or
“PowerBall device”, utilized for this group for a lifting.
strength training program that will be delivered 3. VAS
for 5 sessions per week, following 3 weeks, each
session lasts fora 20-64 minutes. Then frequency Visual Analogue Scale (VAS), tool used for
of the "PowerBall device" will be set by total evaluating a trait or behaviour that is
rounds per minute, which will range from 2000 to thought to vary across a number of values
10000, depending on the subject's capacity. and cannot be calculated directly. It is often
used in observational and clinical studies to
The exercise protocol of Powerball which will be assess the severity or duration of pain
performed is presented below in the Table 1. while at rest or while moving.
3.2 Group B (Control Group) 4.2 Secondary Outcome Measure
1. Range of Motion
In this group, Mulligan Mobilisation with
movement (MMWM) will be performed in the It will be measured using the goniometer
patients with LE. This is a kind of manual instrument. It will help in measuring wrist
treatment wherein the participants lie in a supine and elbow movements. Subjects will be
manner with their elbow extending and their assessed in sitting position as well as
forearm pronated, while performing continuous supine position with full support to the
lateral glides with concomitant physiological elbow. During assessment subjects should
movement to the elbow joint. The clinician stays uncover the forearm and arm and should
by the patient's side, wrapping the belt over his not have accessories.
494Uttamchandani and Phansopkar; JPRI, 33(45B): 491-500, 2021; Article no.JPRI.74474
Fig. 1. Show’s the flow chart of the study
495Uttamchandani and Phansopkar; JPRI, 33(45B): 491-500, 2021; Article no.JPRI.74474
Table 1. The Exercise protocol of PowerBall (Levels of exercise, where A - Mild, B - Moderate, C – Severe)
Weeks Type of Exercise (set*time) Name of training Rest between Rest between Situation Implementation Total
group sets each of Exercise duration of
exercise the exercise
A Exercise 1: Wrist Flexion 1 min 2 min Sitting on the table
(3*30s)
A Exercise 2: 2 min Sitting on the table
(3*30s) Wrist Extension 1 min
1st week A Exercise 3: Elbow Flexion 1 min 2 min Standing
(3*30s) 20 mins
A Exercise 4: Elbow Extension Standing
(3*30s) 1 min 2 min (Trunk flexion)
B Exercise 1: Wrist Flexion 1min
(4*45s) 30 sec 3 min Sitting on the table
B Exercise 2: Wrist Extension 1min 3 min Sitting on the table
(4*45s) 30 sec
2nd week B Exercise 3: Elbow Flexion 1min 3 min Standing 39 mins
(4*45s) 30 sec
B Exercise 4: Elbow Extension 1min 3 min Standing
(4*45s) 30 sec (Trunk flexion)
C Exercise 1: Wrist Flexion 2 min 4 min Sitting on the table
(5*60s)
C Exercise 2: Wrist Extension 2 min 4 min Sitting on the table
(5*60s)
3rd week C Exercise 3: Elbow Flexion 2 min 4 min Standing 64 mins
(5*60s)
C Exercise 4: Elbow Extension 2 min 4 min Standing
(5*60s) (Trunk flexion)
496Uttamchandani and Phansopkar; JPRI, 33(45B): 491-500, 2021; Article no.JPRI.74474
Table 2. The Exercise protocol of MMWM
Week Exercise Rest between sets Situation Implementation of Exercise Total duration
(set*reps)
1st week (3*10) 1 min Sitting on the table 32 mins
(5 sessions)
2nd week (3*15) 1 min Sitting on the table 47 mins
(5 sessions)
3rd week (3*20) 1 min Sitting on the table 62 mins
(5 sessions)
497Uttamchandani and Phansopkar; JPRI, 33(45B): 491-500, 2021; Article no.JPRI.74474
5. DATA COLLECTION AND device and Mulligan Mobilization with movement
MANAGEMENT on patients who are having tennis elbow or LE.
5.1 Data Collection 3. Student’s unpaired t-test
The initial parameters variable will be used to This test is applied on the unpaired data of the
obtain assessment information from a pre- independent observation made on individuals to
created database. Testing data will be put into a see the difference between means of the control
secure REDCap database. Paper records of and the experimental groups.
evaluation forms, signed permission forms, and
other data will be securely maintained in the 6. DISCUSSION
research setting. Electronic information -
collected from the Hand-held dynamometer in Our study aims to estimate the efficacy of
DMIMSU’s electronic repository as per PowerBall device exercises compared to the
participant ID. To enhance participant retention, MMWM, conventional physiotherapy on LE
financial incentives will be given for attending patients' pain and function. According to Babaei-
testing sessions. Additionally, the employment of Mobarakeh et al. [6] resistance training with the
regular feedback concerning adherence and "PowerBall" increased grip strength, shoulders
reminder phone-calls (for attending the in-person and wrists strength, performance of upper
therapy) will be done. The administrator access extremity also proprioception in patients with
rights will lie with the principal investigators (PI). Tennis Elbow aged 22-28 years. According to
researchers, using the "PowerBall device"
5.2 Data Management resulted in enhanced power. Although it has
been proven that utilizing a dynamic PowerBall
The primary researchers will be in charge of improves strength, function, range of motion,
collecting data and documentation. The integrity pain due to Tennis Elbow, and QOL among
of the research information will be extensively overhead athletes, the bulk of common concerns
examined. The Excel spreadsheet will be have yet to be verified. The primary (i.e. PRTEE
released at the end of the study to an allocation index, Hand held dynamometer and VAS) and
blinded statistician for conducting the necessary secondary (i.e. Range of motion) outcome
analysis, following which unblinding of the groups measures will assess the efficacy PowerBall
will be done. Checklists are used to prevent device exercises compared to the MMWM,
missing data due to the improper staff procedure. conventional physiotherapy in Lateral
epicondylitis patients pain and function. The
5.3 Statistical Analysis survey's benefits provide a customized approach
to the rehabilitation protocol and the ability to
The SPSS 24.0 V software will be used and adapt to the individuals' improved competencies
Graph Pad Prism 7.0 V with level of significance, during the treatment. The results of the study will
pUttamchandani and Phansopkar; JPRI, 33(45B): 491-500, 2021; Article no.JPRI.74474
There is no conflict of interest between the COMPETING INTERESTS
writers and manufacturers of the goods because
we do not aim to use them as a means of Authors have declared that no competing
pursuing legal action, but rather to promote interests exist.
knowledge. Furthermore, the study was not
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© 2021 Uttamchandani and Phansopkar; This is an Open Access article distributed under the terms of the Creative Commons
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in any medium, provided the original work is properly cited.
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