| CTRI Number |
CTRI/2024/11/077340 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| 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
|
Comparison between joint movement exercises and joint mobilisation exercises to improve shoulder range of movement in persons with stiff shoulder joint. |
|
Scientific Title of Study
|
Spencer’s Muscle Energy Technique (SMET) versus Mulligan’s Mobilization With Movement (MWM) for persons with Adhesive Capsulitis of Shoulder joint. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saheba Safique |
| Designation |
MPT STUDENT |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Physiotherapy Unit
PMR Department
CMC, Vellore,
Tamil Nadu
632004, India
Vellore
TAMIL NADU
632004
India |
| Phone |
8917577457 |
| Fax |
|
| Email |
sahebasafique071@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Andrew Babu |
| Designation |
Professor and Head |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Physiotherapy Unit,
PMR Department,
Christian Medical College, Vellore- 632004
Vellore
TAMIL NADU
632004
India |
| Phone |
9489590360 |
| Fax |
|
| Email |
andrewb@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Merlyn R |
| Designation |
Associate Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Physiotherapy Unit,
PMR Department,
Christian Medical College, Vellore- 632004
Vellore
TAMIL NADU
632004
India |
| Phone |
6380603255 |
| Fax |
|
| Email |
merlyntilak@gmail.com |
|
|
Source of Monetary or Material Support
|
| Internal - fluid research grant
Office of Research,
Christian Medical College Vellore, Tamil Nadu – 632 002.
College Campus
Tel: 0416 – 228 4294/4289, Hospital Campus 0416-307 5645 Fax: 0416 – 2262788
E-mail: research@cmcvellore.ac.in |
| Physiotherapy Unit,
Christian Medical College, Vellore,
Tamilnadu, South India, Pin code: 632004.
Fax: 04162282158
Phone number: 04162282663
|
|
|
Primary Sponsor
|
| Name |
Internal - fluid research grant |
| Address |
Office of Research,
Christian Medical College Vellore, Tamil Nadu – 632 002.
College Campus
Tel: 0416 – 228 4294/4289, Hospital Campus 0416-307 5645 Fax: 0416 – 2262788
E-mail: research@cmcvellore.ac.in |
| 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 |
| Merlyn R |
Christian Medical College Vellore |
Physiotherapy Unit
PMR Department
Christian Medical College
632004
Vellore
TAMILNADU
Vellore
TAMIL NADU |
0416-2282663
-
merlyntilak@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD (IRB) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M258||Other specified joint disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mulligans mobilisation and Conventional therapy |
Mulligans mobilisation will be given ffor 30 minutes per session and it includes manual mobilisation with movement of the shoulder joint using a mulligan belt. Three sets of 10 repetitions, with 1 minute rest between sets will be given. The same procedure will be performed one session per day for five days.
In addition conventional therapy will be given for 30 minutes per session which includes Isometric shoulder exercises, capsular stretches, finger ladder exercise, pulley rope exercises and wand exercises. Total treatment session will last for 1 hour per day for 5 days. |
| Intervention |
Spencer’s muscle energy technique (MET) and Conventional therapy |
Spencers muscle energy technique will be given for 30 minutes per session and includes 7 steps in movement pattern for shoulder joint which includes:
1.10 reps of extension.
2.10 reps of flexion
3.10 reps of circumduction with compression.
4.10 reps of circumduction with traction.
5.10 reps of abduction and
adduction with external rotation.
6. 10 reps of internal rotation
7.10 reps of distraction with abduction
Conventional therapy will be given for 30 minutes per session and it includes Isometric shoulder exercises, capsular stretches, finger ladder exercise, pulley rope exercises and wand exercises.
Total treatment session will last for 1 hour per day for 5 days. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Persons diagnosed as primary or secondary AC
2. Pain -NPRS (more than 4 out of 10), Intermittent night or resting pain
3. Pain occurring at end range of active and passive movements
4. Active and passive range restriction.
|
|
| ExclusionCriteria |
| Details |
1. Ligament or rotator cuff injuries or tears in shoulder joint
2. Fusion, Ankylosis, Osteoarthritis of shoulder joint
3. Metabolic Bone Disease
4. Neoplastic Disease
5. Malignancies affecting the shoulder region.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Shoulder Active and Passive ROM by Goniometer and Inertial Measurement Unit |
baseline
5th day
3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain, Numerical Pain Rating Scale (NPRS) |
baseline
5th day
3rd month |
| Function, Shoulder Pain & Disability Index (SPADI) |
baseline
5th day
3rd month |
| Muscle power, Modified medical research council grade (mMRC) |
baseline
5th day
3rd month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
09/12/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Once this study is completed ,the study will be published indexed physiotherapy journal. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Persons with shoulder adhesive capsulitis will be assessed for eligibility and will be included after a written consent. Following this baseline assessment will be done by the physical therapist (outcome assessor), who will be blinded to the group allocation. Baseline assessment will include health history and outcomes; measurement of shoulder range using universal goniometer and inertial measurement unit (IMU), pain using Numerical pain rating scale (NPRS), muscle power using modified Medical Research Council (mMRC), shoulder function by using Shoulder Pain and Disability Index (SPADI). After this the patients will be randomized using sequentially numbered, opaque, sealed envelopes (SNOSE) into two groups. The intervention for the two groups will be given by principal investigator (PI). One group will receive Spencer’s muscle energy technique (MET) and the control group will receive Mulligan’s mobilization with movement (MWM) for 5 days. Both the groups will receive conventional therapy in addition. Conventional therapy includes isometric shoulder exercises, capsular stretches, finger-ladder exercise, pulley-rope and wand exercise. At the end of 5 days the outcomes will be reassessed by the physical therapist (Outcome assessor). The data will be analyzed to compare the outcomes following Spencer’s MET and Mulligan’s MWM in persons with shoulder adhesive capsulitis. In addition, we are providing a home exercise program to the patients and the outcomes will be assessed at 3-month follow-up, to evaluate the effect of therapy at 3 months. |