| CTRI Number |
CTRI/2024/07/069829 [Registered on: 02/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| 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 our study, we will look at patients who had surgery to repair rotator cuff (shoulder) muscles. We will give them exercises that reduce the strain (unload) on these muscles to see its effect on pain, function, kinesiophobia (fear of movement), and the thickness of the muscles themselves. |
|
Scientific Title of Study
|
Effect of Rotator Cuff Unloading in Patients with Arthroscopic Rotator
Cuff Repair on Pain, Function, Kinesiophobia and Cuff Diameter- 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 |
Dr Manasi Mandar Waman |
| Designation |
Postgraduate Student |
| Affiliation |
MGM Institute of Physiotherapy, Aurangabad |
| Address |
Department of Musculoskeletal Physiotherapy, OPD-4, MGM
Institute of Physiotherapy, Aurangabad.
Aurangabad
MAHARASHTRA
431003
India
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8452955339 |
| Fax |
|
| Email |
manasi.waman@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanket Mungikar |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, OPD-4, MGM
Institute of Physiotherapy, Aurangabad.
Aurangabad
MAHARASHTRA
431003
India
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9730770107 |
| Fax |
|
| Email |
sanketmungikar@mgmiop.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanket Mungikar |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, OPD-4, MGM
Institute of Physiotherapy, Aurangabad.
Aurangabad
MAHARASHTRA
431003
India
MAHARASHTRA
431003
India |
| Phone |
9730770107 |
| Fax |
|
| Email |
sanketmungikar@mgmiop.edu.in |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Physiotherapy N-6 Cidco, Aurangabad,431003 Maharashtra,India. |
|
|
Primary Sponsor
|
| Name |
MGM Institute of Physiotherapy |
| Address |
N-6 Cidco, Aurangabad,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 |
| Dr Manasi Mandar Waman |
MGM Medical College and Hospital |
Musculoskeletal
Physiotherapy
Department,
OPD-1,MGM Institute of
Physiotherapy, N-6
Cidco, Aurangabad
Aurangabad
MAHARASHTRA
Aurangabad
MAHARASHTRA |
8452955339
manasi.waman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Reseach 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 |
Conventional Physiotherapy |
Conventional physiotherapy:
1. TENS
2. PROM and AROM exercises
3. Scapular control exercises- protraction, retraction, elevation, depression
4. Pendulum exercises
5. Joint mobilization- grade 1 and 2 ( GH distraction, anterior and posterior translational glides).
All exercises will be given to arthroscopic rotator cuff repair patients, 3 sessions/week for 4 weeks |
| Intervention |
Rotator Cuff Unloading Exercises and Conventional Physiotherapy |
Patients in this group will perform 1 exercise from each group of exercises:
1) Semi-closed kinetic chain elevation
2)Deltoid reeducation
3)Assisted arm elevation
4)Exercise for scapular control.
Exercises are grouped and described according to the level of difficulty and muscle activation.
All exercises will be performed in 3 sets of 10 repetitions with a 1 minute interval between repetitions. The exercises are progressed
based on the experienced pain during the program. Only in the presence of symptoms 3 points on the 11-point numeric pain rating scale, a progression towards the next exercise or load is allowed.
All exercises will be given along with given along with conventional physiotherapy to arthroscopic rotator cuff repair patients, 3 sessions/week for 4 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Both male and females
2. Age group between 25-55 years.
3. Arthroscopic repair of any rotator cuff muscle
4. Analgesics |
|
| ExclusionCriteria |
| Details |
1. Central nervous system disorder
2. Peripheral nerve disorder
3. Adhesive capsulitis
4. Systemic inflammatory diseases
5. Shoulder joint osteoarthritis |
|
|
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 |
Pre and Post Intervention Period (4 week) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Function |
Pre and Post Intervention Period (4 week) |
| Kinesiophobia |
Pre and Post Intervention Period (4 week) |
| Cuff Diameter |
Pre and Post Intervention Period (4 week) |
|
|
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 3 |
|
Date of First Enrollment (India)
|
10/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/07/2024 |
| 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 Arthroscopic Rotator Cuff Repair will be included in the study trial if they met the inclusion criteria. The written and oral consent of all patients will be taken, and procedure will be
explained. Demographic data will be noted. Baseline data which includes Pain, Function, Kinesiophobia and Cuff Diameter will be assessed. The patients will be randomly divided into two study groups intervention group and control
group. The patients will receive intervention as per the group allocation for 4 weeks. The
intervention group will receive Unloading exercises for the rotator cuff in addition
to the conventional physiotherapy whereas the control group will receive conventional
physiotherapy only. Rotator Cuff Unloading Exercise Program will include exercises divided into 4 groups namely (Semi-closed kinetic chain elevation, Deltoid reeducation, Assisted arm elevation and Exercise for scapular control). Patients will perform 1 exercise from each group and progression will be made based on pain experienced during the program. Only in the presence
of symptoms < 3 points on the 11-point numeric pain rating scale, a
progression towards the next exercise or load is allowed. All exercises will be given 3 sessions/week for 4 weeks. Conventional Physiotherapy includes TENS, AROM and PROM exercises, gentle joint oscillations, scapular control exercises, pendulum exercise, joint mobilization ( grade 1 and 2- pain relief, glenohumeral traction, anterior and posterior translational glides) which will be given 3 sessions/week for 4 weeks. Outcome measures will be assessed pre and post intervention period of 4 weeks and will include (NPRS, Kinesiophobia using TAMPA scale, function of upper extremity
using DASH and USG). Statistical analysis of the collected data will be done. Conclusion will be established based on the obtained results of the study. |