| CTRI Number |
CTRI/2025/10/096181 [Registered on: 17/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Shoulder and scapula Muscle training program on elbow tendinopathy |
|
Scientific Title of Study
|
Effect of shoulder and scapula Muscle Training Program(SSMT) on pain and functional status in patients with elbow tendinopathy-A Randomized control 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 |
Kirti Khonde |
| Designation |
UG Student |
| Affiliation |
Pravara Institute of Medical Sciences Loni |
| Address |
Sports Physiotherapy Department Dr APJ Abdul Kalam College of
Physiotherapy Pravara Institute of Medical Sciences
Loni Ahmadnagar 413736 Ahmadnagar MAHARASHTRA India
Ahmadnagar
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9970614249 |
| Fax |
|
| Email |
kirtikhonde10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Borkar |
| Designation |
Professor and HOD |
| Affiliation |
Dr APJ Abdul Kalam College of Physiotherapy |
| Address |
Sports Physiotherapy Department,Dr APJ Abdul Kalam College of Physiotherapy Pravara Institute of Medical Sciences Loni Tal Rahata Dist Ahmadnagar Maharashtra
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9168572881 |
| Fax |
|
| Email |
pnb2609@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Borkar |
| Designation |
Professor and HOD |
| Affiliation |
Dr APJ Abdul Kalam College of Physiotherapy |
| Address |
Dr APJ Abdul Kalam College of Physiotherapy Pravara Institute of Medical Sciences Loni Tal Rahata Dist Ahmadnagar Maharashtra
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9168572881 |
| Fax |
|
| Email |
pnb2609@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY, Pravara Institutye of Medical Scieneces, Loni, Ahmednagar, 413736,Maharashtra,India
|
|
|
Primary Sponsor
|
| Name |
DR. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY |
| Address |
Sports Physiotherapy Department, Dr. APJ Abdul Kalam College of
Physiotherapy, Pravara Institute of Medical Sciences,
Loni,Ahmadnagar,413736 Ahmadnagar MAHARASHTRA
India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Kirti Khonde |
Dr. APJ Abdul Kalam College of Physiotherapy |
Sports Physiotherapy Department Dr APJ Abdul Kalam College of
Physiotherapy Pravara Institute of Medical Sciences
Loni Ahmadnagar 413736 Ahmadnagar MAHARASHTRA India
Ahmadnagar
Ahmadnagar
MAHARASHTRA |
09970614249
kirtikhonde10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical comittee |
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 |
conventional group |
1 transcutaneous electrical nerve stimulation
Frequency of 100 Hz
Pulse duration of 150 µs
Placement with two electrode pads applied to the lateral aspect of the elbow and forearm
Time for 20 min
2 Ultrasound
Ultrasound with duty cycle of 20 percent at a
Frequency of 3 MHz
Intensity of 2 W per cm 2
Placement over the lateral epicondyle
Time for 5 min
3 Deep Friction Massage
2–3 min deep friction massage
The deep friction massage consisted of deep circular motions using the fingertips over the area of maximal tenderness at the lateral epicondyle |
| Intervention |
shoulder scapula muscle training program |
Week 1 to 2
1. Shoulder Exercises
Shoulder flexion stretch
5 repetitions 2 sets
Shoulder abduction stretch
5 repetitions 2 sets
Chest stretch
5 repetitions 2 sets
Arm raise exercise
5 repetitions 2 sets
Lateral raise exercise
5 repetitions 2 sets
Pendulum exercise
5 repetitions 2 sets
2. Scapular Exercises
Scapular wall slides
5 repetitions 2 sets
Scapular squeeze
5 repetitions 2 sets
Scapular shrug
5 repetitions 2 sets
Scapular retraction and protraction exercises
5 repetitions 2 sets
3. Elbow Exercises
Gentle flexion range of motion
5 repetitions 2 sets
Gentle extension range of motion
5 repetitions 2 sets
Gentle supination
5 repetitions 2 sets
Gentle pronation
5 repetitions 2 sets
4. Wrist Exercises
Wrist circles
5 repetitions 2 sets
Forearm stretch
5 repetitions 2 sets
Wrist flexion and extension stretch
5 repetitions 2 sets
Gentle ball squeeze
5 repetitions 2 sets
Week 3 to 4
1. Shoulder Exercises
Shoulder wheel exercise
10 repetitions 2 sets
Arm raise exercise with resistance band
10 repetitions 2 sets
Lateral raise exercise with resistance band
Hold for 20 seconds relax for 10 seconds
10 repetitions 2 sets
Shoulder press exercise with resistance band
Hold for 20 seconds relax for 10 seconds
10 repetitions 2 sets
2. Scapular Exercises
Scapular retraction with resistance band
Hold for 20 seconds relax for 10 seconds
10 repetitions 2 sets
Protraction exercise with resistance band
Hold for 20 seconds relax for 10 seconds
10 repetitions 2 sets
Prone Y T I exercise
Hold for 10 seconds relax for 5 seconds
10 repetitions 2 sets
Wall angles exercise
Hold for 20 seconds relax for 10 seconds
10 repetitions 2 sets
3. Elbow Exercises
Isometric elbow flexion exercise
10 repetitions 2 sets
Isometric elbow extension exercise
10 repetitions 2 sets
Biceps curl with resistance band
Hold for 20 seconds relax for 10 seconds
10 repetitions 2 sets
Triceps push down exercise
Hold for 20 seconds relax for 10 seconds
10 repetitions 2 sets
4. Wrist Exercises
Wrist flexion exercise with resistance band
Hold for 20 seconds relax for 10 seconds
10 repetitions 2 sets
Wrist extension exercise with resistance band
Hold for 20 seconds relax for 10 seconds
10 repetitions 2 sets
Eccentric wrist extension exercise with resistance band
Hold for 20 seconds relax for 10 seconds
10 repetitions 2 sets
Wrist curls with resistance band
Hold for 20 seconds relax for 10 seconds
10 repetitions 2 sets
Theraputty exercises
Finger squeeze
Pinch strengthening
Palm press exercises
10 to 15 repetitions 3 sets each
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
pain over the humeral epicondyle with pain severity of at least four on a visual analogue scale for a minimum of 6 weeks score 4 moderate
At a first evaluation session the diagnosis will be verified by increasing pain in at least two of the following:
(1) Tomson test (restricted wrist extension)
(2) Maudsley s test
(3) Mill’s test (full passive flexion of the wrist]
|
|
| ExclusionCriteria |
| Details |
(1) reception of injection or physiotherapy in previous 6 months
(2) concomitant neck or other arm pain necessitating treatment
(3) bilateral elbow pain
(4) Symptoms suggesting radicular neurological or systemic arthritis condition
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
pain: visual analogues scale
functional:
. Patient-Rated Tennis Elbow Evaluation (PRTEE).
. Quick-DASH questioner
|
pain: visual analogues scale
functional:
. Patient-Rated Tennis Elbow Evaluation (PRTEE).
. Quick-DASH questioner
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
28/10/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
To find the effectiveness of
shoulder and scapular muscle training program on pain and functional status in
patient with elbow tendinopathy
|
1.To
find the efficacy of shoulder and scapula muscle training program on pain
using visual analogue scale on the patients with elbow tendinopathy
2. To find the efficacy of shoulder and scapular
muscle training program on functional status using patient rated tennis elbow
evaluation and quick dash upper extremity.
PROCEDURE-
Protocol will be prepared, and ethical clearance
will be obtained from the IEC.
The participants will
be selected based on the inclusion and exclusion criteria for eligibility.
Informed consent will be obtained from the
participants and demographic data is recorded.
Participants will be randomly allocated 2
groups that is the experimental group and control group. Prior assessment of
the participants will be done.
Experimental group A (n=15) will be given Effect of Shoulder and Scapula
Muscle Training Program (SSMT) on pain and functional status in patients with
elbow tendinopathy.
and the control group B (n=15) will be given
conventional exercises.
The participants will be given exercise
regimen and administered to perform.
All the instructions will be given verbally,
provided demonstrate on to the participants statistical analysis will be done
and the results with the conclusion will be mentioned
|
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