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CTRI Number  CTRI/2025/08/092394 [Registered on: 05/08/2025] Trial Registered Prospectively
Last Modified On: 04/08/2025
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   Effect of Therapeutic Movement of Shoulder Complex on Pain and Motion in Individuals with Frozen Shoulder 
Scientific Title of Study   Effect of Scapular Mobilization with Movement (MWM) on shoulder dysfunction in adhesive capsulitis- A randomized controlled 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  Roopa Rao 
Designation  PhD Scholar 
Affiliation  Krishna College of Physiotherapy 
Address  Department of Neurophysiotherapy, Ground Floor, Krishna College of Physiotherapy, Malkapur, Karad

Satara
MAHARASHTRA
415539
India 
Phone  9987228799  
Fax    
Email  roopa.raodanait@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Roopa Rao 
Designation  PhD Scholar 
Affiliation  Krishna College of Physiotherapy 
Address  Department of Neurophysiotherapy, Ground Floor, Krishna College of Physiotherapy, Malkapur, Karad

Satara
MAHARASHTRA
415539
India 
Phone  9987228799  
Fax    
Email  roopa.raodanait@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suraj Kanase 
Designation  Professor 
Affiliation  Krishna College of Physiotherapy 
Address  Department of Neurophysiotherapy, Ground Floor, Krishna College of Physiotherapy, Malkapur, Karad

Satara
MAHARASHTRA
415539
India 
Phone  9881577676  
Fax    
Email  drsurajkanase7@gmail.com  
 
Source of Monetary or Material Support  
Krishna Vishwa Vidyapeeth, Deemed To Be University Research Department, Malkapur, Karad Dist Satara, Maharashtra, India, 415539 
 
Primary Sponsor  
Name  Krishna Vishwa Vidyapeeth Research Department 
Address  Krishna Vishwa Vidyapeeth, Deemed To Be University Malkapur, Karad, Maharashtra, India, 415539 
Type of Sponsor  Other [Deemed University] 
 
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 Roopa Rao  Krishna Hospital  Department of Neurophysiotherapy, Ground floor, Krishna College of Physiotherapy, Malkapur, Karad
Satara
MAHARASHTRA 		 09987228799

roopa.raodanait@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Krishna Institute of Medical Sciences Deemed to be University Karad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Scapular Mobilization with Movement (MWM) with Standard Treatment for Adhesive Capsulitis  Positioning of scapula with active or active assisted mobilization of the glenohumeral joint along with standard treatment. Scapular position is maintained using Kinesio tape after MWM is given. The total intervention will be of 4 weeks duration. 
Comparator Agent  Standard Treatment for Adhesive Capsultis  This consists of glenohumeral MWM (which is known to be effective) along with active and active assisted glenohumeral mobilization, stretching and active strengthening. Kinesio sham taping will be done without any correction. Standard Treatment duration will be of 4 weeks duration total.  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Adhesive Capsulitis at stage 1 or 2 with duration of symptoms less than 3 months, pain with active and passive shoulder ROM and limitation of flexion, abduction, internal rotation and external rotation at least 25 percent reduction in shoulder external rotation compared to unaffected side. Pain on a VAS scale of at least 4 but less than 8. Patient willing to give informed consent 
 
ExclusionCriteria 
Details  Pregnant or breastfeeding women.
Any restriction in shoulder range of motion due to trauma resulting in humerus fracture and dislocation or surgery
Shoulder restriction due to cerebrovascular accident or any other neurological condition
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Scapular Kinematics which includes assessing Scapulohumeral rhythm using inclinometer, clavicular elevation using inclinometer and scapular balance test assessed using vernier calliper

Shoulder Pain and Disability Index or SPADI  		 Scapular Kinematics will be assessed at baseline and at the end of 4th week

Shoulder Pain and Disability Index will be assessed at baseline and at the end of 4th week  
 
Secondary Outcome  
Outcome  TimePoints 
pain using Visual Analogue Scale (VAS)
Range of motion (ROM) using standard universal goniometer
Force Couple ratios - assessed using hand held dynamometer
 		 Pain using VAS will be assessed at baseline & at end of 4th week

ROM will be assessed at baseline & at the end of 4th week
Force couple ratios will be assessed at baseline & end of 4th week  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   01/11/2025 
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="2"
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 - 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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [roopa.raodanait@gmail.com].

  6. For how long will this data be available start date provided 02-05-2028 and end date provided 02-05-2031?
    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   MWM is associated with improvement in pain, range of motion, and function in patients with a range of shoulder musculoskeletal disorders and the effects are clinically significant. Scapular involvement in shoulder function is essential. Most arm functions involve scapular movement. Abnormal scapular movement has been associated with shoulder instability and shoulder impingement syndrome. There is substantial evidence indicating scapular kinematic abnormalities in individuals with shoulder pain. Research has shown that mobility deficits of FS affected not only the glenohumeral but also the scapulothoracic articulation. However, manual therapy techniques have primarily focused on mobilizing the glenohumeral joint in patients with frozen shoulder. Mobilization with movement is a specific form of manual therapy that is gaining increasing popularity, with several studies showing its benefit for a range of shoulder conditions. MWM involves applying a sustained gliding force (the passive mobilization component) while the patient concurrently performs an active movement , the active movement component. When MWM is precisely indicated, it has been shown to improve painful movement and immediately enhance function. As such, MWM differs from passive manual therapy, which is based on a test treat retest approach. There are very few studies examining the effectiveness of scapular mobilization in relation to shoulder joint pain, disability, and range of motion, and these studies have primarily involved passive mobilization.  We hypothesize that scapular MWM given over a period of 4 weeks along with glenohumeral MWM would result in improvement in range of motion , reduce pain and improve scapular kinematics by improving motor control strategy employed by the central nervous system when the glide is successfully applied.

 
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