| CTRI Number |
CTRI/2025/02/079865 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| 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
|
Comparing Dynamic Stretching and Mulligan’s Mobilization for Pain Relief and Improved Movement in Frozen Shoulder: A Clinical Study |
|
Scientific Title of Study
|
EFFECT OF DYNAMIC STRETCHING VERSUS
MULLIGANS MOBILIZATION ON PAIN AND RANGE OF
MOTION IN CASE OF ADHESIVE CAPSULITIS:
RANDOMIZED CONTROL TRIAL |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priya Raj Vishwakarma |
| Designation |
Post Graduate Student (MPT) |
| Affiliation |
Chhatrapati Shahu ji Maharaj University, Kanpur |
| Address |
Department of Physiotherapy, School of Health Sciences,
Chhatrapati Shahu ji Maharaj University, Kanpur
Kanpur Nagar UTTAR PRADESH 208024 India |
| Phone |
7860063601 |
| Fax |
|
| Email |
priya.rv7@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nidhi Agrawal |
| Designation |
Assistant Professor |
| Affiliation |
Faculty of paramedical sciences, Rama university, fourth floor kanpur |
| Address |
Faculty of Paramedical Sciences, fourth floor Rama University, Kanpur
Kanpur Nagar UTTAR PRADESH 209217 India |
| Phone |
9236162828 |
| Fax |
|
| Email |
drnidhiphysio83@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Neha Shukla |
| Designation |
Assistant Professor |
| Affiliation |
Chhatrapati Shahu ji Maharaj University, Kanpur |
| Address |
SHS 101 Department of Physiotherapy, School of Health Sciences,
Chhatrapati Shahu ji Maharaj University, Kanpur
Kanpur Nagar UTTAR PRADESH 208024 India |
| Phone |
7985159439 |
| Fax |
|
| Email |
nehashukla@csjmu.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, School Of Health Sciences, Chhatrapati Shahu Ji Maharaj
University, Kanpur, Uttar Pradesh, India Pin code- 208024 |
|
|
Primary Sponsor
|
| Name |
Priya Raj Vishwakarma |
| Address |
Department of Physiotherapy, School Of Health Sciences, Chhatrapati Shahu Ji Maharaj
University, Kanpur, Uttar Pradesh, India Pin code- 208024 |
| 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 Neha Shukla |
Chhatrapati Shahu ji Maharaj University, Kanpur |
Department of Physiotherapy, School Of Health Sciences, Chhatrapati Shahu Ji Maharaj
University, Kanpur, Uttar Pradesh, India Pin code- 208024 Kanpur Nagar UTTAR PRADESH |
7985159439
nehashukla@csjmu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethical Committee, CSJMU kanpur |
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 |
| Intervention |
experimental group (Group A=20 Participants)- Mulligans mobilization,ultrasound therapy,moist heat pack.
control group (Group B= 20 Participants) -dynamic stretching,ultrasound therapy,moist heat pack. |
Mulligan’s mobilization for 10-30 seconds each glide (3 sets 10 reps) will be given to the experimental group for 1st and 2nd week continuous 6 days. For 3rd and 4th weeks 3 days a week, UST given for 5 minute (f= 1M Hz; I=1W/cm) and moist heat pack will be given for 20 minute at the shoulder joint. Dynamic stretching duration 20 min (20sets/rep) given on control group for 4 weeks rest modalities such as UST and moist heat packs duration sets/rep will be same as experimental group. Combined total duration for both dynamic stretching and mulligans mobilization is 45 minutes per day |
| Comparator Agent |
Dynamic stretching |
Dynamic stretching duration 20 min (20sets/rep) given on control group for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female patients with age group 40-50 years. Having pain in shoulder for at least 3 months. Having unilateral frozen shoulder of stage 3,4 and capsular pattern. Diabetic patients.
|
|
| ExclusionCriteria |
| Details |
Patients having secondary capsulitis, shoulder injury i.e. proximal humerus fracture.
Patients having neurological deficit such as cervical stenosis.
Patients having shoulder surgical history.
Patients having history of other pathological condition of shoulder i.e. impingement syndrome, rotator cuff tear.
Nondiabetic patients.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Shoulder Pain And Disability Index (SPADI).
Visual Analogue Scale (VAS).
Goniometry.
|
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NILL |
NILL |
|
|
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)
|
09/02/2025 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 aim of the research of this study is to answer questions such as which intervention (dynamic stretching or mulligan’s mobilization) is more in reducing pain and range of motion associated with adhesive capsulitis to find out differences in outcomes between dynamic stretching and mulligan’s mobilization in the context of adhesive capsulitis. This study is needed because in the earlier studies, there is comparison between dynamic stretching and mulligan’s technique for pain and range of motion but all the parameters were not taken along with dynamic stretching. Methodology– The experimental study will be conducted in physiotherapy OPD, School of health sciences, Kanpur. The sample will be collected by simple random sampling method based on inclusion and exclusion criteria prior to enrollment of participants in the research, each participant will receive an informed consent form for their voluntary participation. A total 40 male and female patient with age group 40-50 years will be taken and these 40 participants will be divided into two groups 1. experimental group (Group A= 20 Participants) 2. control group (Group B= 20 Participants) on the lottery based randomization. Pre and post assessment of the participants will be done using outcomes measures SPADI, VAS, Goniometry. Mulligan’s mobilization for 10-30 seconds each glide (3 sets 10 reps) will be given to the experimental group for 1st and 2nd week continuous 6 days. For 3rd and 4th weeks 3 days a week, UST given for 5 minute (f= 1M Hz; I=1W/cm) and moist heat pack will be given for 20 minute at the shoulder joint. Dynamic stretching duration 20 min (20sets/rep) given on control group for 4 weeks rest modalities such as UST and moist heat packs duration sets/rep will be same as experimental group. In adhesive capsulitis pain and range of motion is assessed by using SPADI, VAS, Goniometry respectively. |