| CTRI Number |
CTRI/2025/06/088354 [Registered on: 06/06/2025] Trial Registered Prospectively |
| Last Modified On: |
04/06/2025 |
| 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
|
In this study we will be including rotator cufff repair patients; And will be giving routine physiotherapy along with TECAR Machine,and see the effectiveness of TECAR machine on pain, muscle strength, and self-reported function in rotator cuff repair patients. |
|
Scientific Title of Study
|
Exploring the effects of TECAR with routine physiotherapy on pain, Muscle Strength, and self-reported function in patients with rotator cuff repair: A Pilot 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 |
Mrudula Dinesh Dohe |
| Designation |
Post-graduate Student |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, MGM Institute of Physiotherapy, MGM Campus, N-6 Cidco, Chh Sambhajinagar.
Department of Musculoskeletal Physiotherapy, MGM Institute of Physiotherapy, MGM Campus, N-6 Cidco, Chh Sambhajinagar.
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8669391202 |
| Fax |
|
| Email |
mrudula3039@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanket Mungikar |
| Designation |
Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, MGM Institute of Physiotherapy, MGM Campus, N-6 Cidco, Chh Sambhajinagar.
Department of Musculoskeletal Physiotherapy, MGM Institute of Physiotherapy, MGM Campus, N-6 Cidco, Chh Sambhajinagar.
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9730770107 |
| Fax |
|
| Email |
sanketmungikar@mgmiop.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanket Mungikar |
| Designation |
Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, MGM Institute of Physiotherapy, MGM Campus, N-6 Cidco, Chh Sambhajinagar.
Department of Musculoskeletal Physiotherapy, MGM Institute of Physiotherapy, MGM Campus, N-6 Cidco, Chh Sambhajinagar.
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9730770107 |
| Fax |
|
| Email |
sanketmungikar@mgmiop.edu.in |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Physiotherapy N-6 Cidco Chh Sambhajinagar, 431003 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
MGM Institute of Physiotherapy |
| Address |
N-6 Cidco Chh Sambhajinagar,gar, 431003, Maharashtra, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrMrudula Dinesh Dohe |
MGM Medical college and Hospital, Aurangabad |
C building, OPD No. 01, ground floor, Department of Musculoskeletal Physiotherapy, MGM Institute of Physiotherapy, N-6 Cidco, Chh Sambhajinagar Maharashtra India
Aurangabad
MAHARASHTRA |
8669391202
mrudula3039@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAHATMA GANDHI MISSIONS ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M751||Rotator cuff tear or rupture, notspecified as traumatic, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine Physiotherapy
|
1-2 weeks
Reduce pain and inflammation
1. Ice Therapy (15 mins) 3 x a day.
2. Pendulum exercises. (10 repetitions, 2 sets)
3. PROM (internal/external rotation, flexion, abduction 90,) (10 repetitions, 2 sets).
4. AROM: elbow, hand, wrist (10 repetitions, 2 sets).
5. Scapular retraction, chin tucks (10 repetitions, 5-second hold,2 sets).
6. Shoulder Isometrics (Internal and external rotation.) (10 repetitions, 5-second hold,2 sets).
3-4 week
Improve ROM, Enhance scapular stability.
1. PROM: Seated GH flexion table slide, horizontal table slide Forward elevation 120.
2. AAROM and AROM exercises, (Wand exercises) (10 repetitions, 2 sets).
3. Resisted elbow and wrist exercises. (10 repetitions, 2 sets).
4. Pectoral stretches/Cross arm and sleeper posterior capsule stretches, wall slides. (10 repetitions, 2 sets).
5. Pectoral stretches/Cross arm and sleeper posterior capsule stretches, Wall slides. (10 repetitions, 2 sets).
5-6 week
Restore strength, Improve function, Improve endurance, Gradual return to activity and Gradually introduce overhead activities.
1. Progressive resistive training (TheraBand/ Light dumbbells. (flexion, extension, abduction, internal, external rotation) (10 repetitions, 2 sets).
2. Scapular stabilization (Prone T, Y, W exercises), (10 repetitions, 2 sets).
3. Closed-chain Proprioception exercises- wall ball rolls, Weight shifts, wall push-ups. (10 repetitions, 2 sets) |
| Intervention |
TECAR therapy with routine Physiotherapy. |
TECAR will be applied for 20 mins (both resistive and capacitive mode) |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 45-70 years.
2. Both males and females.
3. The rotator cuff Repair patients whose stitches have been taken out following surgery.
4. Patient willing to participate in the study and ready to give consent. |
|
| ExclusionCriteria |
| Details |
1. Patients who had undergone previous upper limb surgery in the last 6 months.
2. Preoperative evidence of fractures, glenohumeral arthritis, or primary adhesive capsulitis.
3. Inflammatory Condition, e.g.: Rheumatoid Arthritis
4. Cognitive or psychiatric disorders.
5. Pregnant and lactating women |
|
|
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 |
| Pain on NPRS (Numerical pain rating scale) |
Pre- and post Intervention (6 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Strength |
Pre- and post Intervention (6 weeks) |
| Self-reported function |
Pre- and post Intervention (6 weeks) |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="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
|
Patients with rotator cuff repair will be included in this study, and those aged 45 to 70 will be taken according to inclusion and exclusion criteria. Before collection of the data informed written consent will be taken from all the participants. The subjects will be interviewed, and the information about the demographic data of patients will be gathered and documented. Baseline values will be established, and patients will be allotted into 2 groups randomly—group A- The control group, and group B, the intervention group—via opaque sealed envelopes. Patients will be asked to rate their pain intensity on the Numerical Pain Rating Scale (NPRS) and fill out the Shoulder Pain and Disability Index (SPADI) Questionnaire, and rotator cuff muscle strength will be evaluated by Microfet 2.0 Dynamometer before the commencement of physiotherapy treatment. The treatment protocol will be conducted for 6 weeks after the stitches of the subject are removed. The treatment protocol will be week-wise. 1-2 weeks Reduce pain and inflammation 1. Ice Therapy (15 mins) 3 x a day. 2. Pendulum exercises. (10 repetitions, 2 sets) 3. PROM (internal/external rotation, flexion, abduction <90,) (10 repetitions, 2 sets). 4. AROM: elbow, hand, wrist (10 repetitions, 2 sets). 5. Scapular retraction, chin tucks (10 repetitions, 5-second hold,2 sets). 6. Shoulder Isometrics (Internal and external rotation.) (10 repetitions, 5-second hold,2 sets).
3-4 week Improve ROM, Enhance scapular stability. 1. PROM: Seated GH flexion table slide, horizontal table slide Forward elevation < 120. 2. AAROM and AROM exercises, (Wand exercises) (10 repetitions, 2 sets). 3. Resisted elbow and wrist exercises. (10 repetitions, 2 sets). 4. Pectoral stretches/Cross arm and sleeper posterior capsule stretches, wall slides. (10 repetitions, 2 sets). 5. Pectoral stretches/Cross arm and sleeper posterior capsule stretches, Wall slides. (10 repetitions, 2 sets).
5-6 week Restore strength, Improve function, Improve endurance, Gradual return to activity and Gradually introduce overhead activities. 1. Progressive resistive training (TheraBand/ Light dumbbells. (flexion, extension, abduction, internal, external rotation) (10 repetitions, 2 sets). 2. Scapular stabilization (Prone T, Y, W exercises), (10 repetitions, 2 sets). 3. Closed-chain Proprioception exercises- wall ball rolls, Weight shifts, wall push-ups. (10 repetitions, 2 sets)
For group B, TECAR will be applied for 20 mins (both resistive and capacitive mode). Patients will be asked to fill same scales, questionnaires and will be evaluated for strength 6 weeks after providing the respective treatments to both the control and intervention groups. |