| CTRI Number |
CTRI/2026/01/101974 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/07/2026 |
| 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
|
The effect of RPMS on frozen shoulder comparing with conservative management |
|
Scientific Title of Study
|
Efficacy of Repetitive Peripheral Magnetic Stimulation and Supervised Exercise on Disability in Frozen Shoulder: A Randomized Double Blinded Sham-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 |
ANANYA |
| Designation |
Post Graduate Student |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Musculoskeletal Sciences and Sports Physiotherapy Department, Institute of
Physiotherapy, Srinivas University, City campus- Ground Floor Room 2, Pandeshwar.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8296402363 |
| Fax |
|
| Email |
ananyaalva13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AJAY KUMAR |
| Designation |
Professor |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Musculoskeletal Sciences and Sports Physiotherapy Department, Institute of
Physiotherapy, Srinivas University, City campus- Ground Floor Room 2, Pandeshwar.
Dakshina Kannada
KARNATAKA
57001
India |
| Phone |
917019238290 |
| Fax |
|
| Email |
drajay@srinivasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
ANANYA |
| Designation |
PG Student |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Musculoskeletal Sciences and Sports Physiotherapy Department, Institute of
Physiotherapy, Srinivas University, City campus- Ground Floor Room 2, Pandeshwar.
Dakshina Kannada
KARNATAKA
5750001
India |
| Phone |
8296402363 |
| Fax |
|
| Email |
ananyaalva13@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTE OF PHYSIOTHERAPY, SRINIVAS UNIVERSITY, PANDESHWAR, MANGALURU, DAKSHINA KANNADA, KARNATAKA, 575001 |
|
|
Primary Sponsor
|
| Name |
ANANYA |
| Address |
Musculoskeletal Sciences and Sports Physiotherapy Department, Institute of
Physiotherapy, Srinivas University, City campus- ground floor Room 2, Pandeshwar, Mangaluru, Dakshina Kannada, Karnataka, 575001 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr ANANYA |
Institute of Physiotherapy, Srinivas University |
Musculoskeletal Sciences and Sports Physiotherapy Department, Institute of
Physiotherapy, Srinivas University, City campus- ground floor, Room 2 Pandeshwar.
Dakshina Kannada
KARNATAKA |
829 6402363
ananyaalva13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board and Ethical Committee(IRBEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Repetitive peripheral magnetic stimulation and supervised exercise |
rPMS of 5-second stimulus at a frequency of 20 Hz with a 15-second interval made up the stimulation settings for 5days per week for 4 weeks Supervised Exercise protocol: Duration: 5days per week Shoulder stretching: Shoulder stretching exercises will be performed in a standing position using a wand for flexion, extension, abduction, internal rotation and external rotation. Ten repetition/set, 2 sets for each direction. Active Range of Motion exercises: It will be performed in standing position for flexion, extension and abduction and in a lying position for internal rotation and external rotation. Ten repetitions/set, 3 sets for each direction. Five seconds rest between two sets. Strengthening exercises: Strengthening exercises include isometric. Theraband isometric exercises will be performed for flexion, abduction, internal rotation and external rotation in standing and lying position. All patients performed the above exercises for 30 min with 2–3 series of 10–15 reps of every exercise. All patients will start strengthening exercises with the yellow color, progress to the red, and then to the green. When the patient can easily complete three sets of 10–15 reps, progression to the next color will be considered.30 Close kinematic chain exercise includes wall push-ups, weight shift in weight-bearing positions and press-ups. The progression should be from partial weight bearing against wall to increasing weight bearing on a table, to quadruped position to modified and full push-up position. Exercises can be progressed from two arm to single arm support. |
| Comparator Agent |
Sham rPMS and supervised exercises |
Sham rPMS 5days per week for 4 weeks
Supervised Exercise protocol:
Duration: 5days per week
Shoulder stretching: Shoulder stretching exercises will be performed in a standing position using a wand for flexion, extension, abduction, internal rotation and external rotation. Ten repetition/set, 2 sets for each direction.
Active Range of Motion exercises: It will be performed in standing position for flexion, extension and abduction and in a lying position for internal rotation and external rotation. Ten repetitions/set, 3 sets for each direction. Five seconds rest between two sets.
Strengthening exercises: Strengthening exercises include isometric. Theraband isometric exercises will be performed for flexion, abduction, internal rotation and external rotation in standing and lying position. All patients performed the above exercises for 30 min with 2–3 series of 10–15 reps of every exercise. All patients will start strengthening exercises with the yellow color, progress to the red, and then to the green. When the patient can easily complete three sets of 10–15 reps, progression to the next color will be considered.30
Close kinematic chain exercise includes wall push-ups, weight shift in weight-bearing positions and press-ups. The progression should be from partial weight bearing against wall to increasing weight bearing on a table, to quadruped position to modified and full push-up position. Exercises can be progressed from two arm to single arm support.
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria are age between 40 and 65 years for both genders; diagnosed with FS (equal limitation of AROM and PROM); and external rotation range restricted by 30degree, or less than or equal to 50 of the opposite side |
|
| ExclusionCriteria |
| Details |
Exclusion criteria are Pacemaker, any metal implants, corticosteroid injection for pain, systemic inflammatory joint disease of the shoulder joint (RA, OA, polymyalgia rheumatica), calcifying tendinitis, glenohumeral synovitis, rotator cuff tendinopathy, shoulder impingement, subacromial bursitis, bicipital tendonitis, cerebral vascular accident, fibromyalgia, neurological deficits of the upper limb (nerve root entrapment, cervical radiculopathy, thoracic outlet syndrome), non-healed fractures of the shoulder complex, acute bursitis, avascular necrosis of the humeral head, and visceral referred pain to the shoulder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Disability of Arm, Shoulder, and Hand (DASH) |
At baseline, 2 weeks, 4 weeks and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
NPRS.
Range of Motion
Hand held Dynamometer
Hand behind the back |
At baseline, 2 weeks, 4 weeks and 3 months |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "14"
Final Enrollment numbers achieved (India)="14" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
23/02/2026 |
| Date of Study Completion (India) |
04/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Primary Purpose: The primary purpose of the study is to find the efficacy of Repetitive Peripheral Magnetic Stimulation and Supervised exercises on Disabilty in Frozen shoulder by comparing it with the sham group. Hypothesis: Alternate hypothesis: rPMS with supervised exercises will improve disability in FS when compared with sham. Null hypothesis: rPMS with supervised exercises will not improve disability in FS when compared with sham. |