| CTRI Number |
CTRI/2025/05/086918 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
13/05/2025 |
| 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
|
A Comparative Analysis of Mobilization with Movement and Class IV LASER Therapy on Disability and Quality of Life among Non- Diabetic Adults with Adhesive Capsulitis. |
|
Scientific Title of Study
|
A Comparative Analysis of Mobilization with Movement and Class IV LASER Therapy on Pressure Pain Threshold, Disability and Quality of Life among Non-Diabetic Adults with Adhesive Capsulitis: A Prospective Experimental Design |
| 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 Mansi Jain |
| Designation |
Ph.D. Scholar |
| Affiliation |
Galgotias University |
| Address |
Galgotias University, Plot No.2, Yamuna Expy, opposite Buddha International Circuit, Sector 17 A, Greater Noida, Uttar Pradesh, 203201.
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9729133235 |
| Fax |
|
| Email |
12345jainmansi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Aksh Chahal |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Galgotias University, Plot No.2, Yamuna Expy, opposite Buddha International Circuit, Sector 17 A, Greater Noida, Uttar Pradesh, 203201.
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9711774174 |
| Fax |
|
| Email |
drakshchahal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Aksh Chahal |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Galgotias University, Plot No.2, Yamuna Expy, opposite Buddha International Circuit, Sector 17 A, Greater Noida, Uttar Pradesh, 203201.
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9711774174 |
| Fax |
|
| Email |
drakshchahal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Mansi Jain |
| Address |
Galgotias University, Plot No.2, Yamuna Expy, opposite Buddha International Circuit, Sector 17 A, Greater Noida, Uttar Pradesh, 203201. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prof Aksh Chahal |
Galgotias University, Plot No.2, Yamuna Expy, opposite Buddha International Circuit, Sector 17 A, Greater Noida, Uttar Pradesh, 203201. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pankaj Sharma |
Jyoti Hospital, Jharsa Road Gurugram. |
Room number-5, Basement, Physiotherapy OPD, Jyoti Hospital 28, HBC Jharsa Road, Gurugram, Haryana
Gurgaon
HARYANA |
7827767758
physiogenix1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School Ethics Committee |
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 |
| Comparator Agent |
Class IV LASER Therapy |
Class IV LASER Therapy will be given 5 times a week for 4 weeks. |
| Comparator Agent |
Conventional Physiotherapy |
Conventional Physiotherapy will be given 5 times a week for 4 weeks. |
| Intervention |
Movement with Mobilization |
Movement with Mobilization will be given for 5 days a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects between 45-75 years
2)Male and Female Subjects
3)Non-Diabetic Adults
4)Patient with unilateral grade I and Grade II Adhesive Capsulitis
5)Diagnosed by physicians with Magnetic Resonance Imaging (MRI).
6)Severe shoulder pain since at least 3 months
7)Severity of pain higher than three out of ten on Numeric Pain Rating Scale
8)Patients with restricted range of passive shoulder flexion, abduction, external rotation, extension of shoulder to less than 50% of contralateral shoulder
|
|
| ExclusionCriteria |
| Details |
1)History of shoulder trauma
2)Glenohumeral osteoarthritis
3)Use of opioid medication
4)History of any recent lungs, breast or bypass surgery
5)Psychiatric or physical illness which make it difficult to complete the treatment.
6)History of neuromuscular disease
7)Skin allergy
8)Surgical history of shoulder and patients with tendon calcification
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numeric Pain Rating Scale(NPRS) |
It will be measured pre & post treatment i.e. at baseline and at 4th week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Shoulder pain and Disability Index (SPADI)
Range of Motion (ROM)
Pain Pressure Threshold |
These will be measure pre and post treatment i.e. before 1st week and after 4th week of the treatment. |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
24/05/2025 |
| 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="4"
Days="5" |
|
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
|
Adhesive Capsulitis is a common idiopathic and self-limiting condition, characterized by painful shoulder stiffness and progressive limitations of both, active and passive shoulder motion following rigidity and fibrosis of joint capsule. It occurs in 2-5 % of the overall population and surprisingly, 20% cases are of diabetes. Exercise therapy intervention with electrotherapy are performed as part of the conventional and ongoing rehabilitation. Purpose: The purposed study aims to evaluate the comparative effect of Mobilization with Movement and Class IV LASER among patients with Adhesive Capsulitis on reducing pain, decreasing disability and improving quality of life. Study Design: A Prospective Experimental Design Method: The present study will recruit patients between 45-75 years on the basis of designed inclusion and exclusion criteria. Patients will be divided randomly in three groups, wherein Group A will Receive Mobilization with Movement (MWM) along with conventional physiotherapy, Group B will receive Class IV LASER along with conventional physiotherapy and the Group C will receive only Conventional Physiotherapy. Primary outcome measure to be used will be Numeric Pain Rating Scale (NPRS) for assessment of pain, and secondary outcome measure will be Shoulder Pain and Disability Index (SPADI), Range of Motion (ROM), and Pain Pressure Threshold. The study intervention will be of 4 weeks and pre and post treatment assessment will be taken.
|