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
|
|
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.
|