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CTRI Number  CTRI/2025/07/091498 [Registered on: 23/07/2025] Trial Registered Prospectively
Last Modified On: 18/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to find out whether the spencer muscle energy technique is effective to improve shoulder function in patient with frozen shoulder. 
Scientific Title of Study   Effectiveness of Spencer Muscle energy technique on Pain, Range of Motion, and Functional Disability in Patients with Frozen Shoulder: An experimental 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 Bhavini koshiya  
Designation  PG Physiotherapy student  
Affiliation  Government physiotherapy collage jamnagarr  
Address  exercise therapy opd, Government physiotherapy collage, near dental collage rameswarnagar , jamnagar Jamnagar GUJRAT 361008 INDIA

Jamnagar
GUJARAT
361008
India 
Phone  9725486915  
Fax    
Email  koshiyagudi123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dineshkumar Sorani  
Designation  masters of physiotherapy in musculoskeletal conditions  
Affiliation  Government physiotherapy collage jamnagarr  
Address  Exercise therapy OPD, Government physiotherapy collage, near dental collage rameswarnagar , jamnagar Jamnagar GUJRAT 361008 INDIA

Jamnagar
GUJARAT
361008
India 
Phone  9725486915  
Fax    
Email  soranidinesh@gmail.com   
 
Details of Contact Person
Public Query  
Name  Dr Bhavini koshiya  
Designation  PG Physiotherapy student  
Affiliation  Government physiotherapy collage jamnagarr  
Address  exercise therapy opd Government physiotherapy collage, near dental collage rameswarnagar , jamnagar Jamnagar GUJRAT 361008 INDIA

Jamnagar
GUJARAT
361008
India 
Phone  9725486915  
Fax    
Email  koshiyagudi123@gmail.com  
 
Source of Monetary or Material Support  
Government physiotherapy collage  
 
Primary Sponsor  
Name  Government physiotherapy collage  
Address  Government physiotherapy collage jamnagar , near dental collage rameswarnagar ,jamnagar . 
Type of Sponsor  Government medical 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 Bhavini koshiya  Government physiotherapy college Jamnagar   exercise therapy department at government physiotherapy college jamnagar neral dental college , rameshwar nagar 361008
Jamnagar
GUJARAT 		 09725486915

koshiyagudi123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee shree M.P.Shah Govt.Medical collage and G.G Govt Hospitaln, jamnagar  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 physiotherapy for adhesive capsulitis   in this there are active assisted range of motion of shoulder, capsular stretching, shoulder girdle exercise, static scapular exercise , Maitland mobilization , progressive resisted exercise, pendular exercise and short wave diathermy  
Intervention  Spencer muscle energy technique for adhesive capsulitis  patient will receive spencer muscle energy technique and conventional physiotherapy for adhesive capsulitis  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Subjects willing to participate in the study Stiff shoulder at least 3 months duration. Idiopathic frozen shoulder. Limited range if motion (Abduction , external rotation ) 40to 65year age group, Bilateral /unilateral frozen. shoulder Both male and female are included. Frozen shoulder( unilateral )( stage 2 and stage 3)With or without DM.

 
 
ExclusionCriteria 
Details  peripheral nerve injury, rheumatoid arthritis, osteoarthritis, malignancies and rotator cuff pathologies were excluded .Thoracic outlet syndrome Unstable shoulder fractureShoulder dislocationComplex regional pain syndrome
Taking pain medication excluded
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Shoulder pain and disability Index(SPADI) Range of motion Of SHOULDER ABDUCTION AND EXTERNAL ROTATION (ROM)
Numericalpain rating scale
 		 All outcome measures will be taken before starting the trial and after 4 weeks (after completion of trial)
 
 
Secondary Outcome  
Outcome  TimePoints 
shoulder pain and disability scale (SPADI)  Baseline(on 1st day)after 4weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/08/2025 
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="0"
Months="8"
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

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

  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 (Others) - 

  6. For how long will this data be available start date provided 01-08-2027 and end date provided 01-08-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Data will be collecting from the patients coming to Government physiotherapy collage -OPD,jamnagar.from this data i will extract the number of patients which are coming to the treatment of Adhesive capsulities(frozen shoulder )
.patient who fit selection criteria will be selected, consent will be taken from patient and patient with frozen shoulder treated with Spencer muscle energy technique along with conventional physical therapy for 4weeks .before and after intervention SPADI , ROM, NPRS will be measured.
Data will be collected over a period of 8 months .
 
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