| CTRI Number |
CTRI/2026/03/105482 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Instrument Assisted Soft Tissue Mobilization Combined With Eccentric Exercise Versus Eccentric Exercise Alone in Individuals With Lateral Epicondylalgia |
|
Scientific Title of Study
|
Effectiveness of Instrument Assisted Soft Tissue Mobilization Combined With Eccentric Exercise Versus Eccentric Exercise Alone in Lateral Epicondylalgia A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikita Sehrawat |
| Designation |
MPT Student |
| Affiliation |
Prakash Institute of Physiotherapy, Rehabilitation and Allied Medical |
| Address |
Department of Physiotherapy
Prakash Institute of Physiotherapy and Allied Sciences
Greater Noida Uttar Pradesh India
Gautam Buddha Nagar
UTTAR PRADESH
201315
India |
| Phone |
918766274830 |
| Fax |
|
| Email |
nikitasehrawat15012000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PUJA SHARMA |
| Designation |
ASSOCITA PROFESSOR |
| Affiliation |
Prakash Institute of Physiotherapy, Rehabilitation and Allied Medical |
| Address |
Department of Physiotherapy
Prakash Institute of Physiotherapy and Allied Sciences
Greater Noida Uttar Pradesh India
Gautam Buddha Nagar
UTTAR PRADESH
201315
India |
| Phone |
9873252361 |
| Fax |
|
| Email |
S.PUJA47@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
PUJA SHARMA |
| Designation |
ASSOCITA PROFESSOR |
| Affiliation |
Prakash Institute of Physiotherapy, Rehabilitation and Allied Medical |
| Address |
Department of Physiotherapy
Prakash Institute of Physiotherapy and Allied Sciences
Greater Noida Uttar Pradesh India
Gautam Buddha Nagar
UTTAR PRADESH
201315
India |
| Phone |
9873252361 |
| Fax |
|
| Email |
S.PUJA47@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Advanced Physiotherapy and Sports Medicine Clinic |
| Address |
C-176,Greater Kailash-1,New Delhi -110048 |
| Type of Sponsor |
Other [Physiotherapy Centre] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashish Sharma |
Advanced Physiotherapy and Sports Medicine Clinic |
ROom no 101 FIRST FLOOR DEPARTMENT OF PHYSIOTHERAPY C-176,Greater Kailash-1,New Delhi -110048
Central
DELHI |
7903707284
drashishsharma.ptnz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Prakash Institute of Physiotherapy Rehabilitation and allied Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Eccentric Exercise Alone |
Participants in the control group will receive the same supervised eccentric exercise program without IASTM. The exercise protocol will include eccentric wrist extensor exercise (3 sets × 10 repetitions), Tyler Twist (3 sets × 15 repetitions), eccentric wrist extension with dumbbell (0.5–1 kg) (3 sets × 10 repetitions), eccentric grip strengthening (3 sets × 10 repetitions), eccentric supination–pronation exercise (3 sets × 10 repetitions), eccentric extensor stretching (3 sets with 20–30 second hold), isometric wrist extension hold (3 sets with 10–15 second hold), and Theraband eccentric wrist extension (3 sets × 10 repetitions). All exercises will be administered under the supervision of a qualified physiotherapist. The intervention will be delivered 3 sessions per week for a total duration |
| Intervention |
Instrument Assisted Soft Tissue Mobilization Combined With Eccentric Exercise |
Participants allocated to the experimental group will receive Instrument-Assisted Soft Tissue Mobilization (IASTM) along with a structured eccentric exercise program. For IASTM application, the patient will be positioned comfortably with the forearm supported. The treatment area over the forearm extensor muscles at the lateral epicondyle will be exposed, cleaned, and an emollient applied. A standard stainless steel IASTM tool will be used. The technique will include scanning strokes followed by sweeping and fanning strokes along the muscle fibers, applied in both longitudinal and cross-fiber directions. Mild to moderate pressure, as tolerated by the patient, will be applied for 5–8 minutes per session. IASTM will be administered 3 sessions per week.
In addition, participants will perform a supervised eccentric exercise program consisting of: eccentric wrist extensor exercise (3 sets × 10 repetitions), Tyler Twist (eccentric forearm extensor twist) (3 sets × 15 repetitions), eccentric wrist extension with dumbbell (0.5–1 kg) (3 sets × 10 repetitions), eccentric grip strengthening (3 sets × 10 repetitions), eccentric supination–pronation exercise (3 sets × 10 repetitions), eccentric extensor stretching (3 sets with 20–30 second hold), isometric wrist extension hold (3 sets with 10–15 second hold), and Theraband eccentric wrist extension (3 sets × 10 repetitions). All exercises will be performed under the supervision of a qualified physiotherapist. The total frequency of sessions will be 3 sessions per week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Individuals aged between thirty and forty five years
Both male and female participants
Clinically diagnosed unilateral lateral epicondylalgia
Pain over the lateral epicondyle aggravated by resisted wrist extension
Duration of symptoms more than six weeks
Willingness to participate and provide informed consent |
|
| ExclusionCriteria |
| Details |
History of fracture surgery or trauma to the elbow or forearm
Presence of cervical radiculopathy or neurological disorders affecting upper limb
Systemic inflammatory conditions such as rheumatoid arthritis
Recent corticosteroid injection to the affected elbow within last three months
Participation in any other physiotherapy treatment during the study period |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain Intensity measured using Visual Analog Scale |
WEEK 0,WEEK 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Grip Strength measured using Hand Held Dynamometer
Functional Disability measured using Patient Rated Tennis Elbow Evaluation Questionnaire |
WEEK 0,WEEK 4 |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized controlled trial aims to evaluate the effectiveness of Instrument Assisted Soft Tissue Mobilization combined with eccentric exercise compared to eccentric exercise alone in individuals with lateral epicondylalgia. A total of sixty eight participants will be randomly allocated into experimental and control groups. Outcome measures will include pain intensity grip strength and functional disability. The findings of this study are expected to provide evidence regarding the clinical benefits of combining Instrument Assisted Soft Tissue Mobilization with eccentric exercise in the management of lateral epicondylalgia. |