| CTRI Number |
CTRI/2024/09/073203 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
28/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the effect of Graded Motor Imagery V/S Scapular Stabilization Exercises on Pain, ROM, Kinesiophobia, and Shoulder Function in Frozen Shoulder: A Randomized Clinical Trial |
|
Scientific Title of Study
|
Effect of Graded Motor Imagery V/S Scapular Stabilization Exercises on Pain, ROM, Kinesiophobia , Shoulder Function in Individuals With Frozen Shoulder - A Randomized Clinical 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 |
Mahima Inamdar |
| Designation |
Postgruduate |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, Department of Orthopedic Physiotherapy, OPD no 39,Room no 18, Nehru Nagar Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9620237204 |
| Fax |
|
| Email |
mahimainamdar454@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aarti welling |
| Designation |
Assistant Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, Department of Orthopedic Physiotherapy, OPD no 39,Room no 18, Nehru Nagar Belagavi Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9448814569 |
| Fax |
|
| Email |
aartiwell88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aarti welling |
| Designation |
Assistant Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, Department of Orthopedic Physiotherapy ,OPD no 39,Room no 18, Nehru Nagar Belagavi Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9448814569 |
| Fax |
|
| Email |
aartiwell88@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Research, Nehru Nagar Belagavi Karnataka - 590010 |
|
|
Primary Sponsor
|
| Name |
Kle Academy of Higher Education and Research |
| Address |
kaher Institute of Physiotherapy, Department of Orthopedic Physiotherapy, OPD no 39,Room no 18, Nehru Nagar Belagavi Karnataka- India.
pin code:590010 |
| Type of Sponsor |
Private 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 |
| Aarti welling |
KLE’s DR. Prabhakar Kore Hospital and Research |
kAHER Institute of Physiotherapy, Department of Orthopedic Physiotherapy, OPD no 39,Room no 18, Nehru Nagar Belagavi Karnataka
Belgaum
KARNATAKA |
9448814569
aartiwell88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Academy of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Graded Motor Imagery + Conventional Treatment
|
graded motor imagery along with conventional treatment will be given for 3 weeks everyday,9 sessions in total.
|
| Comparator Agent |
Scapular Stabilization + Conventional Treatment |
scapular stabilization exercises ( thera band) along with conventional treatment will be given for 3 times per week alternate days, 9 sessions in total.
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Participants:
1) All gender subjects, diagnosed with frozen shoulder between the age group 40- 65 years.
2) Individuals clinically diagnosed with stage1 and 2 of frozen shoulder
3) Subject with or without diabetes.
4) Willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1)Individuals having Neurological conditions (stroke, Parkinson, cervical radiculopathy.)
2)Individuals with previous neck or shoulder surgery
3)Individuals having any history of shoulder fracture or dislocation
4)Individuals were on oral analgesics or any pain-relieving medications
5)Individuals with Severe psychiatric illness.
6)Patients with CABG usually tend to develop frozen shoulder
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assesment of pain using numeric pain rating scale,shoulder function using disability of the arm,shoulder, and hand questionnaire, Assesment of kinesiophobia using tampa scale for kinesiophobia, Shoulder ROM assesment using universal goniometer |
pre- baseline
post - after 3 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
20/09/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
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
|
Effect of Graded Motor Imagery VIS Scapular Stabilization Exercises on Pain, ROM, Kinesiophobia, Shoulder Function in Individuals with Frozen Shoulder - A Randomized Clinical Trial Aim of the study- To compare the effect of graded motor imagery and scapular stabilization exercises on pain, ROM, kinesiophobia, shoulder function in individuals with frozen shoulder. Null hypothesis- There will be no difference in effect of motor imagery V/S Scapular stabilization exercises on pain, ROM, kinesiophobiaand shoulder function in individuals with frozen shoulder. Alternate hypothesis-There will be difference in the effect of motor imagery V/S Scapular stabilization exercises on pain, ROM, kinesiophobia and shoulder function in individuals with frozen shoulder Inclusion criteria- 1) All gender subjects, diagnosed with frozen shoulder between the age group 40- 65 years. 2) Individuals clinically diagnosed with stage and 2 of frozen shoulder 3) Subject with or without diabetes. 4) Willing to participate in the study. Exclusion criteria- 1) Individuals having Neurological conditions (stroke, Parkinson, cervical radiculopathy.) 2) Individuals with previous neck or shoulder surgery 3) Individuals having any history of shoulder fracture or dislocation 4) Individuals were on oral analgesics or any pain-relieving medications 5) Individuals with Severe psychiatric illness. 6) Patients with CABG usually tend to develop frozen shoulder
|