FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/064788 [Registered on: 27/03/2024] Trial Registered Prospectively
Last Modified On: 04/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Mobilization with movement for shoulder pain and movement dysfunction 
Scientific Title of Study   Short term effectiveness of mobilization with movement with or without exercise over sham on function, pain and mobility for patients with shoulder pain and movement dysfunction: Randomized control 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  Pallavi Mali 
Designation  post graduate student 
Affiliation  Smt. Kashibai Navale College of Physiotherapy Narhe Pune 
Address  Smt. Kashibai Navale College of Physiotherapy Narhe Pune Second floor Room No 202
Smt. Kashibai Navale College of Physiotherapy Narhe Pune Second floor Room No 202
Pune
MAHARASHTRA
411041
India 
Phone  8689842608  
Fax    
Email  pallavimali0299@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kiran Satpute 
Designation  Professor 
Affiliation  Smt. Kashibai Navale College of Physiotherapy Narhe Pune 
Address  Smt. Kashibai Navale College of Physiotherapy Narhe Pune Second floor Room No 202
Smt. Kashibai Navale College of Physiotherapy Narhe Pune Second floor Room No 202
Pune
MAHARASHTRA
411041
India 
Phone  9604515538  
Fax    
Email  kiran_ptist@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Pallavi Mali 
Designation  post graduate student 
Affiliation  Smt. Kashibai Navale College of Physiotherapy Narhe Pune 
Address  Smt. Kashibai Navale College of Physiotherapy Narhe Pune. Second floor Room No 202
Smt. Kashibai Navale College of Physiotherapy Narhe Pune. Second floor Room No 202
Pune
MAHARASHTRA
411041
India 
Phone  8689842608  
Fax    
Email  pallavimali0299@gmail.com  
 
Source of Monetary or Material Support  
Smt. Kashibai Navale College of Physiotherapy Sr. no 48/55/1, 48/56/1 Off westerly by pass Narhe Pune Maharashatra 
 
Primary Sponsor  
Name  Smt. Kashibai Navale College of Physiotherapy 
Address  Off westerly By pass Narhe Pune 
Type of Sponsor  Other [Private physiotherapy College] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kiran Satpute PT  Smt, Kashibai Navale Medical College and General Hospital   Physiotherapy OPD ground floor, OPD No. 10 Off Westerly by pass, Near Narhe Police station, Narhe, Pune 411041,
Pune
MAHARASHTRA 		 9604515338

kiran_ptist@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee of Smt. Kashibai Navale College of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M759||Shoulder lesion, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Moist heat mobilization with movement  Moist heat will be applied as a hydrocollator pack for 10-15 minutes. Mobilization with the movement applied pragmatically for shoulder flexion, rotations, and hand behind-the-back movement. 6-8 repetitions, 2-3 sets per session, per movement. 3 sessions per week for 2 weeks. Self-mobilization with movement continued at home with 6-8 repetitions, 2-3 sets once a day.  
Comparator Agent  Moist heat. Exercise. Sham mobilization with movement. Home exercise.   Moist heat will be applied as a hydrocollator pack for 10-15 minutes. Scapular and Shoulder exercises against elastic band resistance. Assisted Shoulder mobility exercises. 8 to 12 reps, 2-3 sets, and resistance will progress depending on patient compliance. Hand position similar to that of mobilization with movement applied on patient skin for the same duration but without application on any forces. The patient will perform the active movements in pain-free range. 3 sessions per week for 2 weeks. Home exercise will be the same exercises continued at home once a day  
Comparator Agent  Moist heat. Exercises. Mobilization with movement. Home exercise.   Moist heat will be applied as a hydrocollator pack for 10-15 minutes. Scapular and Shoulder exercises against elastic band resistance. Assisted Shoulder mobility exercises. 8 to 12 reps, 2-3 sets, and resistance will progress depending on patient compliance. Mobilization with the movement for shoulder flexion, rotations, and hand behind-the-back movement. 6-8 repetitions, 2-3 sets per session. 3 sessions per week for 2 weeks. Home exercise will be the same exercises continued at home once a day  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Restriction of shoulder flexion range of motion between 60 - 100 degrees.
Symptoms for more than 3 months.
Pain intensity more than 5 on the Numeric rating scale.
 
 
ExclusionCriteria 
Details  History of injury to shoulder, fractures around shoulder and thoracic area, thoracic surgeries, Cervical radiculopathy in last 3 months, diabetes more than 5 years.
Contraindications to manual therapy. Thoracic surgery. Unable to understand commands. old or recent Upper motor neuron or peripheral nerve lesions.
 
 
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 
Shoulder disability measured with Shoulder Pain and Disability Index  Baseline, 2 weeks, 13 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Range of motion of shoulder flexion, external rotation, Hand behind back, Shoulder pain intensity  Baseline, 2 weeks, 13 weeks 
 
Target Sample Size   Total Sample Size="63"
Sample Size from India="63" 
Final Enrollment numbers achieved (Total)= "63"
Final Enrollment numbers achieved (India)="63" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/04/2024 
Date of Study Completion (India) 04/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 04/07/2025 
Estimated Duration of Trial   Years="1"
Months="6"
Days="20" 
Recruitment Status of Trial (Global)
Modification(s)  		 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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kiran_ptist@yahoo.co.in].

  6. For how long will this data be available start date provided 24-12-2025 and end date provided 24-12-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This 3 armed randomized control trial will evaluate the short-term effectiveness of mobilization with movement on people with shoulder pain and movement dysfunction. intervention will be delivered for 2 weeks and blinded assessment will be performed at baseline, 3 weeks, and 13 weeks 
Close