| CTRI Number |
CTRI/2024/07/070584 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
28/07/2024 |
| 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
|
A clinical trial to study the effect of Radial shockwave therapy and Ultrasound therapy in Adhesive Capsulitis patients |
|
Scientific Title of Study
|
Comparative efficacy of Radial Shockwave Therapy and Ultrasound Therapy on pain, range of motion and function in subjects with Adhesive Capsulitis: 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 |
Deepak Sharma |
| Designation |
Post Graduate Student |
| Affiliation |
National Institute for Locomotor Disabilities (Divyangjan) |
| Address |
Room number 117, Department of Physiotherapy National Institute for Locomotor Disabilities (Divyangjan) BT Road, Bonhooghly, Kolkata
North Twentyfour Parganas
WEST BENGAL
700090
India |
| Phone |
9572361342 |
| Fax |
|
| Email |
ds04773@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amrita Mukherjee |
| Designation |
Lecturer |
| Affiliation |
National Institute for Locomotor Disabilities (Divyangjan) |
| Address |
Room number 117, Department of Physiotherapy National Institute for Locomotor Disabilities (Divyangjan) BT Road, Bonhooghly, kolkata
North Twentyfour Parganas
WEST BENGAL
700090
India |
| Phone |
7384361511 |
| Fax |
|
| Email |
m.amrita007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepak Sharma |
| Designation |
Post Graduate Student |
| Affiliation |
National Institute for Locomotor Disabilities (Divyangjan) |
| Address |
Room number 117, Department of Physiotherapy National Institute for Locomotor Disabilities (Divyangjan) BT Road, Bonhooghly, Kolkata
North Twentyfour Parganas
WEST BENGAL
700090
India |
| Phone |
9572361342 |
| Fax |
|
| Email |
ds04773@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute for Locomotor Disabilities (Divyangjan) BT Road, Bonhooghly, kolkata West Bengal, India - 700090 |
|
|
Primary Sponsor
|
| Name |
Deepak Sharma |
| Address |
National Institute for Locomotor Disabilities (Divyangjan) BT, Road, Bonhooghly, Kolkata West Bengal Pin Code - 700090 |
| 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 Deepak Sharma |
National Institute for Locomotor Disabilities (Divyangjan) |
Room Number 117, Department of Physiotherapy, National Institute for Locomotor Disabilities (Divyangjan) BT, Road, Bonhooghly, Kolkata
North Twentyfour Parganas
WEST BENGAL |
9572361342
ds04773@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee, National Institute for Locomotor Disabilities (Divyangjan) |
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 |
| Intervention |
Radial Shockwave Therapy |
Radial Shockwave Therapy (RSWT) for 4 sessions [2 sessions per week (on 1st, 4th, 7th and 10th day)].Glenohumeral joint mobilization, Supervised Exercise Program (5 sessions per week for 2 weeks) and Home Exercise Program once a day in home during 2 weeks of tratment period. |
| Comparator Agent |
Ultrasound Therapy |
Ultrasound Therapy for 10 sessions (5 sessions per week for 2 weeks). Glenohumeral joint mobilization, Supervised Exercise Program (5 sessions per week for 2 weeks) and Home Exercise once a day in home during 2 weeks of tratment period. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Both male and female subjects.
2.Age between 40-60 years.
3.Subjects with Adhesive Capsulitis stage II and III.
4.VAS score between 3-7. |
|
| ExclusionCriteria |
| Details |
1.Surgical history of shoulder joint or cervical spine.
2.Diagnosed cases of musculoskeletal conditions like Rotator cuff tendinitis or injury, fracture around shoulder, Shoulder impingement syndrome, upper limb deformity etc.
3.Diagnosed cases of neurological conditions like Stroke, Parkinson’s disease etc.
4.Rheumatological diseases like Rheumatoid Arthritis, Ankylosing Spondylitis.
5.Red flag sign like Malignancy, Vascular disorders.
6.History of oral steroid in last 1 month and intraarticular corticosteroid injection for Adhesive Capsulitis in last 3 months.
7.Implanted Pacemaker.[27]
8.Non-cooperative subjects. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain by Visual Analogue Scale (VAS).
2.Active Abduction, External and Internal rotation ROM by Universal half circle goniometer.
3.Function by Shoulder Pain and Disability Index (SPADI) |
2 times - on day 0 and after 2 weeks of interventions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
25/07/2024 |
| 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)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
PURPOSE OF THE STUDY:
There are various studies available which shows the individual efficacy and few comparative efficacy of Radial Shockwave Therapy and Ultrasound Therapy in subjects with Adhesive Capsulitis. However, to the best of our knowledge out of those studies, no study has been conducted to find the comparative efficacy of Radial Shockwave Therapy and Ultrasound Therapy on pain, range of motion and function in Indian population with Adhesive Capsulitis Subjects.
So, the purpose of the study is to find out the comparative efficacy of Radial Shockwave Therapy and Ultrasound Therapy on pain, range of motion and function in subjects with Adhesive Capsulitis.
AIMS:
To compare the efficacy of Radial Shockwave Therapy and Ultrasound Therapy on pain, range of motion and function in subjects with Adhesive Capsulitis.
OBJECTIVES:
1.To find out the efficacy of Radial Shockwave Therapy with Glenohumeral joint mobilization and supervised exercise on pain, range of motion and function in subjects with Adhesive Capsulitis.
2.To find out the efficacy of Ultrasound Therapy with Glenohumeral joint mobilization and supervised exercise on pain, range of motion and function in subjects with Adhesive Capsulitis.
3.To compare the efficacy of Radial Shockwave Therapy and Ultrasound Therapy on pain, range of motion and function in subjects with Adhesive Capsulitis.
HYPOTHESES
NULL HYPOTHESIS (H0): There is no statistically significant difference between the efficacy of Radial Shockwave Therapy and Ultrasound Therapy on pain, range of motion and function in subjects with Adhesive Capsulitis.
ALTERNATIVE HYPOTHESIS (H1): There is statistically significant difference between the efficacy of Radial Shockwave Therapy and Ultrasound Therapy on pain, range of motion and function in subjects with Adhesive Capsulitis.
PROCEDURE
Approval from the Institutional Ethical Committee (IEC) will be taken before commencement of the study. All subjects having shoulder pain or diagnosed with Adhesive Capsulitis by the Assessment clinic of National Institute for Locomotor Disabilities (Divyangjan) and referred to the Department of Physiotherapy will be approached with the proposal of the study. Based on the inclusion and exclusion criteria 34 subjects will be included in the study. Subjects meeting the exclusion criteria will not be included. Those fulfilling the inclusion criteria will be explained about the study in details in their communicable language and written informed consent will be taken. Then, the subjects will be randomly divided into 2 groups by block randomization method by computer generated random blocks. The demographic data and outcome measures for Pain using VAS, active ROM by Universal half circle goniometer and function by SPADI questionnaire will be collected from each subject pre-intervention and post-intervention after 10th sessions at the end of 2 weeks. In Group-A subjects will be treated with Radial Shockwave Therapy (RSWT) for 4 sessions [2 sessions per week (on 1st, 4th, 7th and 10th day)]. In Group-B subjects will be treated with Ultrasound Therapy for 10 sessions (5 sessions per week for 2 weeks). Glenohumeral joint mobilization, Supervised Exercise Program (5 sessions per week for 2 weeks) and Home Exercise Program will be given in both the groups.
All the rescue medications, prescribed by the physicians will be continued in both the groups along with Physio-therapeutic approach during the study. |