| CTRI Number |
CTRI/2025/05/086602 [Registered on: 08/05/2025] Trial Registered Prospectively |
| Last Modified On: |
07/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of a Manual Therapy Technique for Shoulder Joint and Task-Specific Exercises Based on Daily activities for Improving Shoulder Movement, Reducing Pain, and Overcoming Fear of Movement in People with Frozen Shoulder |
|
Scientific Title of Study
|
Effectiveness Of Spencer’s Technique Versus Task Specific Exercise In Improving Range Of Motion, Pain And Fear Of Movement In Individuals With Frozen Shoulder: 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 |
Dr Harsha Wadhwani |
| Designation |
Post-graduate scholar |
| Affiliation |
MGM School of Physiotherapy |
| Address |
MGM School of Physiotherapy, MGM campus, N6 Cidco, Central Naka Road, Chi. Sambhajinagar Maharashtra India 431003
Aurangabad MAHARASHTRA 431003 India |
| Phone |
9404880712 |
| Fax |
|
| Email |
harsha14wadhwani@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rinkle Malani |
| Designation |
Director and Professor |
| Affiliation |
MGM School of Physiotherapy |
| Address |
MGM School of Physiotherapy, MGM campus, N6 Cidco, Central Naka Road, Chi. Sambhajinagar Maharashtra India 431003
Aurangabad MAHARASHTRA 431003 India |
| Phone |
9370312412 |
| Fax |
|
| Email |
rinkle.malani@mgmsop.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Rinkle Malani |
| Designation |
Director and Professor |
| Affiliation |
MGM School of Physiotherapy |
| Address |
MGM School of Physiotherapy, MGM campus, N6 Cidco, Central Naka Road, Chi. Sambhajinagar Maharashtra India 431003
Aurangabad MAHARASHTRA 431003 India |
| Phone |
9370312412 |
| Fax |
|
| Email |
rinkle.malani@mgmsop.edu.in |
|
|
Source of Monetary or Material Support
|
| MGM School of Physiotherapy, Chh. Sambhajinagar Maharashtra India 431003 |
|
|
Primary Sponsor
|
| Name |
MGM School of Physiotherpy |
| Address |
MGM School of Physiotherapy MGM campus, N6 CIDCO, Chh. Sambhajinagar Maharashtra India 431003 |
| 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 |
| Dr Harsha Wadhwani |
MGM School of Physiotherapy |
MGM Medical and Hospital N6 CIDCO, Central Naka Road, Chh. Sambhajinagar Maharashtra India 431003 Aurangabad MAHARASHTRA |
9404880712
harsha14wadhwani@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: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Spencers Technique |
This technique consists of 7 different motions of glenohumeral joint, where the therapist applies manual resistance towards the direction of constricted barrier. These 7 steps include:
Step 1: Shoulder extension with elbow flexion
Step 2: Shoulder flexion with elbow extension
Step 3: Circumduction with compression
Step 4: Circumduction with distraction
Step 5: Shoulder abduction and internal rotation with elbow flexion
Step 6: Shoulder adduction and external rotation with elbow flexion
Step 7: Stretching tissue and pumping fluids with the arm extended
This technique will help to improve ROM for shoulder joint using the Muscle Energy Technique |
| Comparator Agent |
Task Specific Exercise |
The participants are given verbal ques to perform the functional tasks. The participants are required to complete the given tasks in a given amount of time. These tasks are done for 5 sessions per week for 3 weeks. The list of tasks along with dosage are given below:
1. Lifting object from a lower height 10 reps x 3 sets
2. Transferring objects from one side to other 10 reps x 3 sets
3. Switching buttons on and off 10 reps x 3 sets
4. Placing objects on higher shelves 10 reps x 3 sets in flexion 10 reps x 3 sets in abduction
5. Clapping overhead 10 reps x 3 sets
6. Pulling out and pushing in a drawer 10 reps x 3 sets
7. Transferring objects from front to back 10 reps x 3 sets
8. Combing hair 10 reps x 3 sets
9. Reaching for back pocket 10 reps x 3 sets
These tasks will help in resuming the activities of daily living.
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age of the participants between 40-60 years.
2. Limited and painful passive ROM for shoulder.
3. Pain and stiffness which is gradual on onset and progressive in nature.
4. Patients with 1st and 2nd stages of frozen shoulder.
5. Male and female participants who are willing to participate.
6. Clinically diagnosed cases of frozen shoulder. |
|
| ExclusionCriteria |
| Details |
1. Participants with visual or auditory impairment.
2. Participants with involvement of bilateral shoulders.
3. Participants with prior neck or shoulder surgeries in past 6 months.
4. Participants with previous history of fractures near shoulder or dislocation of shoulder in past 6 months.
5. Participants with any neurological involvement. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Range of Motion (Goniometer) |
Baseline and three weeks post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numerical Pain Rating Scale (NPRS) |
Baseline and three weeks post treatment |
| Tampa Scale of Kinesiophobia (TSK) |
Baseline and three weeks post treatment |
|
|
Target Sample Size
|
Total Sample Size="32" Sample Size from India="32"
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 4 |
|
Date of First Enrollment (India)
|
30/05/2025 |
| 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
|
Frozen shoulder, or adhesive capsulitis, is a condition characterised by pain, stiffness, and limited range of motion in the shoulder joint, significantly affecting daily activities. This randomized clinical trial aims to compare the effectiveness of Spencer’s Technique—a structured manual therapy involving specific mobilization movements—and Task-Specific Exercises, which are functional movements based on daily tasks, in improving shoulder range of motion, reducing pain, and minimizing fear of movement (kinesiophobia) in individuals with frozen shoulder. Participants will be randomly assigned to either the Spencer’s Technique group or the Task-Specific Exercise group. Both groups will receive interventions over a defined period under professional supervision. Outcome measures will include joint range of motion, pain intensity (measured by a numerical pain rating scale (NPRS)), and fear of movement (assessed using the Tampa Scale for Kinesiophobia). The study seeks to identify which intervention is more effective in restoring function and enhancing the quality of life for individuals with frozen shoulder. |