| CTRI Number |
CTRI/2025/09/094826 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of a combined exercise therapy including PNF, rotator cuff strengthening for recovery from adhesive capsulitis |
|
Scientific Title of Study
|
Effects of Proprioceptive Neuromuscular Facilitation and Capsular Stretching with Rotator Cuff Strengthening Exercise for Patients with Adhesive Capsulitis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Md Naim Asrafi |
| Designation |
Undergraduate Student |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room no: 304, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408
Other |
| Phone |
8801737753678 |
| Fax |
|
| Email |
naimasrafi2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ehsanur Rahman |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room: 401, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408
Other |
| Phone |
8801716062263 |
| Fax |
|
| Email |
e.rahman@just.edu.bd |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ehsanur Rahman |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room: 401, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408
Other |
| Phone |
8801716062263 |
| Fax |
|
| Email |
e.rahman@just.edu.bd |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore- 7408, Bangladesh |
|
|
Primary Sponsor
|
| Name |
Dr Ehsanur Rahman |
| Address |
Room no: 401, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore- 7408, Bangladesh |
| Type of Sponsor |
Other [Public University] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Md Kabir Hossain |
Dr M R Khan Medical Center |
Level-3, Room: 303, Musculoskeletal Lab, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore- 7408
|
880 1778315139
kabir2002pt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB of Department of Physiotherapy & Rehabilitation, JUST |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, (2) ICD-10 Condition: M258||Other specified joint disorders, (3) ICD-10 Condition: M243||Pathological dislocation of joint,not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
The Proprioceptive Neuromuscular Facilitation technique, Capsular stretching, Rotator Cuff Strengthening
|
1. Proprioceptive Neuromuscular Facilitation (PNF): D2F Pattern (Flexion, Abduction, External Rotation) using the Hold Relax Technique: 10 sets × 5 reps/set, 5 second hold, 2 second rest, Total duration 15 minutes/session.
Scapular PNF Patterns: Anterior Elevation & Posterior Depression: 5 sets × 5 reps/set, 5 second hold, 2 second rest (7 minutes), Posterior Elevation & Anterior Depression: 5 sets × 5 reps/set, 5 second hold, 2 second rest (8 minutes).
2. Capsular Stretching Techniques: Glenohumeral Caudal Glide (for abduction),
Posterior Anterior Glide (for flexion and internal rotation)
Anterior Posterior Glide (for extension and external rotation), Scapulothoracic Mobilization (for elevation, depression, protraction, retraction, and rotation)
Dosage: 10 repetitions per technique per session.
3. Rotator Cuff Strengthening Exercises:
Pendulum Swings: 2 × 30 seconds, Isometric External and Internal Rotation at the side: 3 × 10-second holds, Shoulder Sling Exercises: 3 × 10 reps, Thera band Strengthening: 3 × 10 reps, Side Lying Dumbbell External Rotation: 3 × 10 reps, Session Duration: 45 minutes/session, Frequency: 4 sessions per week, Total Duration of Intervention: 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed with unilateral adhesive capsulitis based on Cyriax capsular pattern concept by a qualified physiotherapist.
Duration of shoulder pain between 1 to 3 months. |
|
| ExclusionCriteria |
| Details |
A history of using drugs due to adhesive capsulitis and surgery on the shoulder or manipulation under anesthesia.
Neurologic deficits affecting shoulder function during ADL or diagnosed as brachial plexopathy by nerve conduction study (NCS)
Pain or disorders of the cervical spine, elbow, wrist or hand.
Other conditions involving the shoulder as rotator cuff tear or tendinitis, etc.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary Outcome: Numeric Pain Rating Scale(NPRS)for pain |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcome: Goniometer for AROM/PROM measure, Shoulder Pain and Disability Index (SPDI) for functional activities, Manual Muscle Testing (MMT) for rotator cuff strength.
|
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="0"
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)
|
01/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/10/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [e.rahman@just.edu.bd].
- For how long will this data be available start date provided 01-02-2026 and end date provided 01-02-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study aims to evaluate the effects of Proprioceptive Neuromuscular Facilitation (PNF), capsular stretching, and rotator cuff strengthening exercises on reduce pain, improve muscle strength,and shoulder range of motion in adults aged 25-70 years diagnosed with unilateral adhesive capsulitis. Participants will undergo a 6-week intervention program with four sessions per week, each lasting 45-60 minutes. Primary Outcome include pain (NPRS), Secondary outcome include strength (MMT), ROMby Goniometer assessments, and Shoulder Disability (SPDI). The study is designed as a non-randomized clinical trial conducted at the Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST) and the Centre for the Rehabilitation of the Paralysed (CRP), Savar. This research aims to provide evidence-based physiotherapy protocols to improve shoulder function and reduce pain in patients with adhesive capsulitis. |