| CTRI Number |
CTRI/2024/08/072552 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of integrated exercise program on pain, range of motion, strength and function in subjects with adhesive capsulitis : A prospective study |
|
Scientific Title of Study
|
Effect of Novel Integrated Exercise Program on pain, range of motion, strength and function in subjects with adhesive capsulitis: A prospective study
|
| 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. Swaral Kiran Deshmukh |
| Designation |
post graduate student |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy |
| Address |
1st floor, Department of Musculoskeletal Physiotherapy,Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy, 11/12 Thube Park, Shivajinagar,
Pune – 411 005
Pune
MAHARASHTRA
411005
India |
| Phone |
9373239625 |
| Fax |
|
| Email |
swaralk05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venu Mohan Dharmapuri |
| Designation |
Associate Professor of Musculoskeletal Department |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy,Department of Musculoskeletal physiotherapy, 11/12 Thube Park, Shivajinagar,
Pune – 411 005
Pune
MAHARASHTRA
411Â 005
India |
| Phone |
9440690707 |
| Fax |
|
| Email |
venumohan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venu Mohan Dharmapuri |
| Designation |
Associate Professor of Musculoskeletal Department |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy,Department of Musculoskeletal Physiotherapy , 11/12 Thube Park, Shivajinagar,
Pune – 411 005
Pune
MAHARASHTRA
411Â 005
India |
| Phone |
9440690707 |
| Fax |
|
| Email |
venumohan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy, Department of Musculoskeletal Physiotherapy
11/12 Thube Park, Shivajinagar,
Pune – 411 005
|
| 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 |
| Swaral Kiran Deshmukh |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
Sancheti Institute for
Orthopaedics and
Rehabilitation College
of Physiotherapy, Department of Musculoskeletal Physiotherapy,11/12
Thube Park Shivaji
Nagar Pune 411005
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9373239625
swaralk05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sancheti Institute for Orthopaedics and Rehabilitation Institutional Ethics Committee |
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 |
| Intervention |
Novel Integrated Exercise Program |
Mulligan mobilization posterolateral and inferior glide
Myofascial release for subscapularis, pectoralis major, latissimus dorsi
Strengthening for scapular muscles
Stretching for upper trapezius, pectoarlis minor, levator scapulae
Kinetic control
3 days a week for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with stage 2 adhesive capsulitis between the age group of 45-60
years.
Subjects with shoulder pain for more than 3 months.
Subjects with a range of motion loss of greater than 25% in at least 2 planes.
Subjects with a capsular pattern of external rotation, more restricted than
abduction followed by internal rotation or flexion |
|
| ExclusionCriteria |
| Details |
Presence of any other co-existing pathologies such as glenohumeral arthritis,
rotator cuff pathology, etc.
Subjects with a recent history of trauma
Post-surgical stiffness
Presence of referred pain such as cervical spondylosis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale
Universal goniometer
MicroFET 3 Dynamometer |
2weeks, 4 weeks, 6 weeks, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Shoulder pain and disability index |
0 weeks, 2 weeks, 4 weeks, 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/08/2024 |
| Date of Study Completion (India) |
15/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Adhesive capsulitis is an inflammatory condition characterized by shoulder stiffness, pain, significant loss of active and passive range of motion, and restriction in activities of daily living.It has been claimed that 10–20% of patients experience long-term disability, while 30–60% of individuals continue to have symptoms. Morbidity from adhesive capsulitis has a significant individual and societal cost, and disability is always long-lasting, if not permanent. Adhesive capsulitis is a pathological process which involves excessive scar tissue or adhesions across the glenohumeral joint that leads to joint and fascial restrictions causing stiffness, pain and scapula dysfunction. So, the treatment methods that involve joint mobilization, soft tissue mobilization, scapula strengthening and stretching program and kinetic control helps restore the position, direction, muscle movement control, to improve shoulder joint function and stabilize the scapula in subjects with adhesive capsulitis.There’s a strong need to develop effective treatment strategies tailored to the individual’s condition that can lead to shorter treatment durations and improved functional recovery.The current study therefore proposes to analyze the effect of the Novel Integrated Exercise Program on pain, range of motion, strength, and function in subjects with adhesive capsulitis. |