| CTRI Number |
CTRI/2026/02/104118 [Registered on: 17/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two Physiotherapy techniques for reducing pain, improving grip strength and hand function in Tennis elbow subjects. |
|
Scientific Title of Study
|
Pain release phenomenon versus gross myofascial release in combination with eccentric exercise on pain threshold, grip strength and function in subjects with lateral epicondylitis: A randomized clinical 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 |
Saniya Sanjay Dessai |
| Designation |
Postgraduate student (Orthopaedic Physiotherapy) |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Orthopaedic Physiotherapy Department Room
Nagar, Belagavi, Karnataka-590010 Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
9657696896 |
| Fax |
|
| Email |
saniyadessai02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Peeyoosha Gurudut |
| Designation |
Professor and Head of Department |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Orthopaedic Physiotherapy Department Room
Nagar, Belagavi, Karnataka-590010 Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
|
| Email |
peeoo123@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Peeyoosha Gurudut |
| Designation |
Professor and Head of Department |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Centre Orthopaedic Physiotherapy Department Room
Nagar, Belagavi, Karnataka-590010 Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
|
| Email |
peeoo123@yahoo.com |
|
|
Source of Monetary or Material Support
|
| KAHER Institute of Physiotherapy, Nehru Nagar, Belagavi, Karnataka-590010 |
|
|
Primary Sponsor
|
| Name |
Saniya Sanjay Dessai |
| Address |
KAHER Institute of Physiotherapy, Nehru Nagar, Belagavi, Karnataka-590010 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Peeyoosha Gurudut |
KAHER Institute of Physiotherapy, Nehru Nagar, Belagavi, Karnataka-590010 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saniya Sanjay Dessai |
KLES Dr. Prabhakar Kore Hospital and MRC |
Advanced Physiotherapy Centre Orthopaedic Physiotherapy Department Room No. 18, Nehru Nagar, Belagavi, Karnataka 590010 Belgaum KARNATAKA
Belgaum
KARNATAKA |
9657696896
saniyadessai02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research & Ethical Committee KLEU Institute of Physiotherapy Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M771||Lateral epicondylitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gross myofascial release |
Gross Myofascial Release is a manual therapy technique involving the application of sustained, low-load, long duration stretching to the fascia and associated soft tissues. The technique aims to reduce fascial restrictions, improve tissue extensibility, decrease pain and restore functional mobility. It is believed to act through mechanical deformation of fascial adhesions, improved local circulation and neuromodulation of nociceptive pathways.
It will be given five times a week for two weeks. |
| Intervention |
Pain release phenomenon |
The Pain Release Phenomenon technique is a manual therapy method used in lateral epicondylitis that produces immediate pain relief by applying sustained pressure at the tender point. It works through neuromodulation, gate control mechanisms and reduction of muscle spasm.
It will be given five times a week for two weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults aged 18-60 years diagnosed clinically with Sub-acute / chronic lateral epicondylitis confirmed with positive Cozen’s test.
2.Duration of symptoms more than 6 weeks.
3.Pain on NPRS 4-7.
|
|
| ExclusionCriteria |
| Details |
1.Neurological deficits affecting the upper limb.
2.Previous corticosteroid injection in affected elbow within 3 months.
3.Pregnancy.
4.Epileptic patients.
5.Any skin condition such psoriasis, eczema, etc.
6.History of elbow fracture or surgery.
7.Systemic inflammatory conditions.
8.Any open wound around the upper limb such as a cut, laceration.
9.Acute lateral epicondylitis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain pressure threshold using algometer.
2. Grip strength using hand dynamometer. |
1. Pain pressure threshold will be assessed at baseline and at two weeks.
2. Grip strength will be assessed at baseline and at 2 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pain threshold using NPRS.
2. Function using Patient rated tennis elbow evaluation questionnaire. |
1.Pain threshold will be assessed at baseline and at 2 weeks.
2. Function will be assessed at baseline and at 2 weeks.
|
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
28/02/2026 |
| 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
|
Lateral
epicondylitis (tennis elbow) is a chronic degenerative tendinopathy affecting
the extensor carpi radialis brevis tendon, leading to pain, reduced grip
strength and functional limitations in daily activities. Although eccentric exercise remains a
cornerstone of rehabilitation, adjunctive manual therapy techniques such as
Pain Release Phenomenon and Gross Myofascial Release may provide additional
benefits in pain reduction and functional recovery. This randomized clinical
trial aims to evaluate and compare the effectiveness of Pain release phenomenon
versus Gross myofascial release, each combined with eccentric exercises, on
pain threshold, grip strength and functional status in subjects with lateral
epicondylitis. Pain will be assessed using the Numeric Pain Rating Scale and
Pain Pressure Algometer, grip strength using a hand dynamometer and functional
status using the Patient-Rated Tennis Elbow Evaluation questionnaire. Outcomes
will be measured at baseline and post-intervention. The findings of this study
may help determine the more effective adjunct manual therapy approach in the
physiotherapeutic management of lateral epicondylitis.
|