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CTRI Number  CTRI/2025/12/098384 [Registered on: 03/12/2025] Trial Registered Prospectively
Last Modified On: 02/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA)
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Occupational therapy treatment for Frozen shoulder 
Scientific Title of Study   Effectiveness of occupation-based intervention on occupational performance and quality of life in frozen shoulder : 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  Sridhar D 
Designation  Assistant Professor Senior Scale  
Affiliation  Manipal College of Health Professions MAHE Manipal  
Address  Department of Occupational Therapy Manipal college of Health Professions Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone  9886216433  
Fax    
Email  sridhar.d@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivek Pandey 
Designation  Professor 
Affiliation  Kasturba Medical College MAHE Manipal  
Address  Department of Orthopaedics Kasturba Medical College Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone  9871564313  
Fax    
Email  vivek.pandey@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Vivek Pandey 
Designation  Professor 
Affiliation  Kasturba Medical College MAHE Manipal  
Address  Department of Orthopaedics Kasturba Medical College Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone  9871564313  
Fax    
Email  vivek.pandey@manipal.edu  
 
Source of Monetary or Material Support  
Self-sponser, study will be conducted in the Department of Occupational Therapy, Kasturba hospital, MAHE, space will provided in therapy area as per procedures  
 
Primary Sponsor  
Name  Sridhar D  
Address  Department of occupational therapy Manipal College of Health Professions Manipal Academy of Higher education Manipal 576 104  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sridhar D  Kasturba Hospital Department of occupational therapy Manipal   Department of Occupational Therapy Manipal College of Health Professions MAHE Manipal
Udupi
KARNATAKA 		 9886216433

sridhar.d@manipal.edu 
Dr Vivek Pandey  Kasturba Hospital Department of Orthopedics Manipal   Department of orthopaedics Kasturba Medical college Kasturba hospital Manipal Academy of Higher Education Manipal 576 104
Udupi
KARNATAKA 		 9871564313

vivek.pandey@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KASTURBA MEDICAL COLLEGE and KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTE  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 
Comparator Agent  Conventional therapeutic exercises   conventional therapeutic exercises as a home program for eight weeks, generally prescribed therapeutic exercises for frozen shoulder. Conventional therapeutic exercises will be based on the participant’s occupational issues (e.g. bathing, combing, etc.). Eight weeks program will be provided to participants as an e-copy or a printout copy, which should be followed during home program sessions. Gradation of exercises from waist level to overhead level, duration, and no. of sessions per week will be mentioned in the handout and logbook to monitor the regularity of the sessions performed and all exercises will be performed within tolerable pain limit. 
Intervention  Experimental Group Interventions   Participants will receive occupation-based interventions (OBI) that include (Preparatory task + Activities and Occupation) as a home program for eight weeks, NEWLY developed occupation-based interventions based on literature evidence will be prescribed for frozen shoulder. OBI will be based on the participant’s occupational issues (e.g. bathing, combing, etc.). Eight weeks program will be provided to participants as an e-copy, which should be followed during home program sessions. Gradation from waist level to overhead level, duration, and no. of sessions per week will be mentioned in the handout and logbook to monitor the regularity of the sessions performed and OBI will be performed within tolerable pain limit to a tolerable pain limit. Participants will record eight weeks of home program therapy sessions in a logbook to monitor their regularity and phone communication for any clarification and suggestions if required as requested as per study trial participant and consent. Three contact sessions with the investigator after enrolled in the study; Initial (first evaluation), post-treatment evaluation (after 4 weeks), and final post-treatment evaluation (after 8 weeks); the participant may use the external ointment for shoulder pain as prescribed by the consulting doctor, if in case the participant is unable to report to follow-up evaluation during the second(4-6 weeks) and third (8-10 weeks) contact session, a telephone interview will be considered to adhere to the time frame of evaluation procedures.  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  The participants diagnosed with a frozen shoulder or primary adhesive capsulitis with or without diabetes in the freezing stage or frozen stage

Aged between 35 to 65 years of both gender

Participants can read and write the local (Kannada) or English language to follow the study procedures and provide consent to participate in this study, to provide consent to participate in this study or through patient party/informants that includes consent to follow up communication through telephone or get/give clarification related to the research study.
 
 
ExclusionCriteria 
Details  Secondary conditions associated with shoulder injuries, rotator cuff injury, fractures, shoulder surgeries, and intervention cardiac conditions (CABG, Pacemaker, and other conditions).

The participants with other neurological, congenital anomalies, deformities, and psychosocial disorders with frozen shoulder
 
 
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 
Canadian Occupational Performance Measures (COPM)

Shoulder Pain and Disability Index (SPADI)

SF-36 Health-related Quality of Life Questionnaire (SF-36)  		 Time points of evaluation to compare the effectiveness from baseline to 4-6 weeks, and 8-10 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Shoulder Forward Flexion Reach in the scapular plane (Clinical test)

Jamar Dynamometer 		 after four weeks and after eight weeks 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   20/12/2025 
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="6"
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  
Conservative treatment for frozen shoulder (FS) was studied using various intervention methods including therapeutic exercises and modalities, however, the occupation-based intervention (OBI) was not included in those studies. OBI utilizes activities and occupation as interventions to enhance the occupational performance of an individual’s daily occupation and quality of life in clients with FS is not much explored. The proposed research study can help in choosing OBI for the client with FS and other shoulder conditions. The outcome of this will be added research evidence and facilitate the use of OBI in occupational therapy clinical practice through the home program. Considering current situations OBI home program interventions will be cost-effective and feasible to keep the treatment follow-up. Thus, there is a need to conduct quality research on OBI in clients with FS.
The study will be conducted only after the approval of the IEC-KH and Clinical Trial Registry of India (CTRI). 
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