| CTRI Number |
CTRI/2024/08/072455 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
10/08/2024 |
| 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
|
Comparing one technique namely graded motor imagery with other technique namely pain neuroscience education in patients having frozen shoulder in terms of its impact on pain perception, severity, disability and range |
|
Scientific Title of Study
|
Effectiveness of pain neuroscience education versus graded motor imagery on pain intensity, pain belief, disability and range of motion in patients with frozen shoulder |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Virul |
| Designation |
Post Graduate Student |
| Affiliation |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma, University of Health Sciences, Rohtak |
| Address |
College of Physiotherapy, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8307118402 |
| Fax |
|
| Email |
virullohan40@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Megha Gakhar |
| Designation |
Assistant Professor |
| Affiliation |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma, University of Health Sciences, Rohtak |
| Address |
College of Physiotherapy, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9896232146 |
| Fax |
|
| Email |
meghs80@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Virul |
| Designation |
Post Graduate Student |
| Affiliation |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma, University of Health Sciences, Rohtak |
| Address |
College of Physiotherapy, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8307118402 |
| Fax |
|
| Email |
virullohan40@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Physiotherapy, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak, Haryana 124001 India |
|
|
Primary Sponsor
|
| Name |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma, University of Health Sciences, Rohtak |
| Address |
College of Physiotherapy, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak, Haryana 124001 India |
| Type of Sponsor |
Government medical college |
|
|
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 Virul |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma, University of Health Sciences, Rohtak |
Room number 3, Post graduate laboratory, E block
Rohtak
HARYANA |
8307118402
virullohan40@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak |
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 |
Graded motor imagery |
Graded motor imagery include three stages named laterality recognition, explicit motor imagery and mirror therapy. Each stage will be applied for two weeks along with conventional exercise protocol for adhesive capsulitis of shoulder. Total twelve sessions will be provided with each session conducted twice a week for six consecutive weeks. Hence, each stage will include four sessions. Baseline reading measuring pain intensity, pain belief, disability and range of motion will be taken before first session. Subsequent readings measuring above parameters will be taken after six sessions and twelve sessions. |
| Comparator Agent |
Pain neuroscience education |
First session include information and education to patient via print media along with conventional exercise protocol for adhesive capsulitis of shoulder.
In subsequent sessions, patient will be encouraged to ask questions and receive clarification for doubts along with conventional exercise protocol for adhesive capsulitis of shoulder. Total twelve sessions will be provided with each session conducted twice a week for six consecutive weeks. Baseline readings measuring pain intensity, pain belief, disability and range of motion will be taken before first session. Subsequent readings measuring above parameters will be taken after six sessions and twelve sessions. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Painful and restricted shoulder passive range of motion (primarily in external rotation).
Gradual onset and progressive worsening of pain and stiffness.
Stage 1 and 2 of frozen shoulder.
Individuals without diabetes mellitus. |
|
| ExclusionCriteria |
| Details |
Visually impaired subjects.
Pain and incomplete range of motion in both shoulders.
Previous neck or shoulder surgery.
Subacromial pain syndrome, painful arc syndrome and a positive apprehension test.
Any history of fracture, dislocation, or having any signs of neurological involvement. |
|
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Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain intensity with the numeric pain rating scale.
Pain belief with pain catastrophizing scale.
Shoulder disability with shoulder pain and disability index.
Range of motion with universal goniometer. |
Day 0
Session 6
Session 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
26/08/2024 |
| 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
|
The study aims to evaluate the effectiveness of pain neuroscience education versus graded motor imagery on pain intensity, pain belief, disability and range of motion in patients with frozen shoulder. Fifty eligible participants will be divided into two groups ; group 1 receiving pain neuroscience education along with conventional treatment and group 2 undergoing graded motor imagery along with conventional treatment. Baseline and follow-up assessments using standardized scales will be conducted, and data will be analyzed using appropriate statistical methods to determine the intervention’s effectiveness.
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