| CTRI Number |
CTRI/2026/02/103610 [Registered on: 11/02/2026] Trial Registered Prospectively |
| Last Modified On: |
10/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate the effectiveness of pulsed electromagnetic stimulation on pain and shoulder movement in individuals with frozen shoulder |
|
Scientific Title of Study
|
Effect of Pulse Electromagnetic Stimulation on Pain and Functional Mobility in Patients with 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 |
Misbah Anjum |
| Designation |
PG Scholar |
| Affiliation |
Amity University Noida |
| Address |
Department of Physiotherapy,AIHAS,F1 Block Amity University Uttar Pradesh, Noida Sector 125
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9717706196 |
| Fax |
|
| Email |
anjummisbah55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rabab Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Amity University Noida |
| Address |
Department of Physiotherapy,AIHAS,F1 Block Amity University Uttar Pradesh, Noida Sector 125
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9654478155 |
| Fax |
|
| Email |
rkaur4@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Rabab Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Amity University Noida |
| Address |
Department of Physiotherapy,AIHAS,F1 Block Amity University Uttar Pradesh, Noida Sector 125
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9654478155 |
| Fax |
|
| Email |
rkaur4@amity.edu |
|
|
Source of Monetary or Material Support
|
| Amity Institute of Health Allied Science
Noida,Uttarpradesh |
|
|
Primary Sponsor
|
| Name |
Misbah Anjum |
| Address |
AIHAS,F1 Block Amity University Uttar Pradesh, Noida Sector 125 |
| 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 Rabab Kuar |
Amity Physiotherapy clinic |
Amity University Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9654478155
rkaur4@amity.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee Department of Physiotherapy, AIHAS, Amity University Uttar Pradesh, Noida, Uttar Pradesh, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
Identical ROM exercises, stretching, strengthening, and manual therapy, but without PEMS. |
| Intervention |
PEMS + Conventional Physiotherapy |
20-30 mins of PEMS (300 Hz) plus ROM, stretching, strengthening, and manual therapy. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants aged between 40 and 60 years.
Both males and females will be included.
Individuals experiencing shoulder pain with
limited range of motion.
Participants must be able to comprehend
instructions and provide informed consent. |
|
| ExclusionCriteria |
| Details |
• Patients with secondary frozen shoulder resulting from trauma or surgical procedures.
• Individuals having metallic implants or any
contraindications to PEMS therapy
Those with neurological impairments affecting the
upper limb
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain intensity will be
measured using the Numerical Pain Rating Scale
(NPRS) |
12 sessions across a four-week
period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Shoulder range of motion will be assessed with a
goniometer, and functional status will be
evaluated using the Shoulder Pain and Disability
Index (SPADI).
|
12 sessions across a four-week
period |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/02/2026 |
| 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="6"
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
|
The objective of this randomized controlled trial is to evaluate the therapeutic efficacy of Pulsed Electromagnetic Stimulation (PEMS) as an adjunct to conventional physiotherapy for managing frozen shoulder (adhesive capsulitis). A total of 30 participants will be recruited via convenient sampling and randomly assigned to one of two arms. Group A (Experimental) will receive PEMS in addition to a conventional physiotherapy regimen consisting of range of motion exercises, stretching, and manual therapy. Group B (Control) will receive the conventional physiotherapy regimen alone. The intervention will be administered 3 times per week for a duration of 4 weeks (total 12 sessions). Primary outcomes include pain intensity measured by the Numerical Pain Rating Scale (NPRS), while secondary outcomes include shoulder range of motion via goniometry and functional disability measured by the Shoulder Pain and Disability Index (SPADI). Assessments will be conducted at baseline, weekly, and post-intervention to determine significant differences between the two treatment protocols. |