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CTRI Number  CTRI/2025/04/085300 [Registered on: 22/04/2025] Trial Registered Prospectively
Last Modified On: 15/04/2025
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   Impact of Magneto therapy on Pain, Range of motions, shoulder Function in patients with Frozen Shoulder 
Scientific Title of Study   Effect of Magneto therapy on Pain, Range of motion, and Function in individuals with Shoulder 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  Sahil Kumar 
Designation  MPT student 
Affiliation  Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation 
Address  Department of Physiotherapy, Maharishi Markandeshwar (Deemed to br University), Mullana

Ambala
HARYANA
133207
India 
Phone  9519567913  
Fax    
Email  sak19980001234@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sandeep Pattnaik 
Designation  Assistant Professor 
Affiliation  Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation 
Address  Department of Physiotherapy, Maharishi Markandeshwar (Deemed to br University), Mullana

Ambala
HARYANA
133207
India 
Phone  9348096886  
Fax    
Email  physiosandeep94@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sandeep Pattnaik 
Designation  Assistant Professor 
Affiliation  Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation 
Address  Department of Physiotherapy, Maharishi Markandeshwar (Deemed to br University), Mullana

Ambala
HARYANA
133207
India 
Phone  9348096886  
Fax    
Email  physiosandeep94@gmail.com  
 
Source of Monetary or Material Support  
Orthopedic Physiotherapy Research Laboratory, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana, 133207 
 
Primary Sponsor  
Name  Sahil Kumar 
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, India, 133207 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Sandeep Pattnaik  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, 133207 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sahil Kumar  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation  Room No.2, Ground Floor, Maharishi Markandeshwar (Deemed to be University), Mullana, 133207
Ambala
HARYANA 
9519567913

sak19980001234@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee, Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana-Ambala   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  1. Conventional therapy  Participants will receive only Conventional for 45 minutes per session, 5 sessions per week, for another 2 weeks. 
Intervention  1. Magneto Therapy 2. Conventional Therapy  1. Participants will receive Magnetotherapy for 15 minutes per session, 5 sessions per week, for 2 weeks. 2. They will receive Conventional Therapy, including cane exercises, wall slides, shoulder stretch of the anterior capsule, posterior capsule and inferior capsule, towel stretch, and shoulder rotator cuff isometrics (hold for 10- 15sec and 10 reps, 2 sets) for 45 minutes per session, 5 sessions per week, for another 2 weeks. 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Age between 35 and 50 years.
2. Both male and female participants.
3. Diagnosis of Stage 1 or Stage 2 shoulder adhesive capsulitis, confirmed by clinical presentation and symptoms. 
 
ExclusionCriteria 
Details  1. Recent shoulder surgery.
2. Rheumatoid arthritis.
3. History of shoulder trauma or fracture.
4. Osteoporosis or malignancy in the shoulder region.
5. Neurological deficits affecting shoulder function.
6. Rotator cuff lesion or tendon calcification.
7. Pain or disorders of the cervical spine, elbow, wrist, or hand on the affected side.
8. Prior physiotherapy intervention within the past 3 months. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Pain intensity assessed by the Numerical Pain Rating Scale (NPRS).
2. Shoulder Active and Passive Range of Motion (ROM);
3. Shoulder function evaluated by the Shoulder Pain and Disability Index (SPADI). 
At:
1. Pre-intervention (immediatly after recruitment)
2. Post-intervention (after 10 sessions of intervention) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 2 
Date of First Enrollment (India)   01/05/2025 
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="1"
Months="0"
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 - NO
Brief Summary  
Shoulder Adhesive Capsulitis, often referred to as "Frozen Shoulder," is a painful condition characterized by a significant loss of shoulder joint motion. Inflammation and thickening of the joint capsule lead to the formation of adhesions, restricting movement and causing discomfort. This condition typically progresses through three stages: freezing, frozen, and thawing. During the freezing and frozen stages, inflammation of the shoulder capsule is the primary cause of symptoms, resulting in pain, decreased range of motion, and impaired upper extremity function. Physiotherapeutic interventions are commonly employed to counter
these inflammatory changes and alleviate symptoms. Magnetotherapy is one such treatment,though its efficacy for shoulder adhesive capsulitis has been less extensively studied compared to its use for other shoulder conditions.This study aims to investigate the effect of Magneto therapy on pain, range of motion, and function in individuals with shoulder adhesive capsulitis. Participants will be recruited based on defined inclusion and exclusion criteria. Following recruitment, participants will be randomly assigned to either Group 1 or Group 2 using a computer-generated randomization sequence. Group 1 participants will receive both magnetotherapy and conventional physiotherapy, while Group 2 participants will receive conventional physiotherapy only. Pre- and post-intervention assessments will be conducted to evaluate pain intensity using the Numerical Pain Rating Scale, shoulder range of motion using a universal goniometer, and shoulder function using the Shoulder Pain and Disability Index.Each physiotherapy session will last 45 minutes and will be conducted five times per week for two weeks. The Shapiro-Wilk test will be used to assess the normality of the data. If the data are normally distributed, paired t-tests will be used for within-group comparisons and independent t-tests will be used for between-group comparisons. If the data are not normally distributed, Wilcoxon signed-rank tests will be used for within-group comparisons, and the Kruskal-Wallis test will be used for between-group comparisons. This research aligns with a patient-centered approach, fostering a deeper understanding of the effect of Magneto therapy as a physiotherapeutic intervention for individuals with shoulder adhesive capsulitis.

 
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