| CTRI Number |
CTRI/2023/10/058668 [Registered on: 16/10/2023] Trial Registered Prospectively |
| Last Modified On: |
13/10/2023 |
| 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
|
Effects of compression therapy technique with an elastic band on pain, and daily activities in addition to regular treatment in patients with stiff shoulder |
|
Scientific Title of Study
|
Effects of Tissue Flossing on Pain, Range of motion and Functions as an Adjunct to Standardized Protocol in Adhesive Capsulitis Patients |
| 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 Aishwarya Shirude |
| Designation |
MPT student |
| Affiliation |
Sunandan divatia school of sciences |
| Address |
Nanavati Max Super Speciality Hospital LIC colony vile parle west
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
8655430045 |
| Fax |
|
| Email |
aishushirude@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Khadijeh Menai |
| Designation |
Assistant Professor- Physiotherapy |
| Affiliation |
Sunandan Divatia school of science |
| Address |
Sunandan Divatia School of Science, SVKM Bhaktivedanta road, vile
parle west
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
9823390277 |
| Fax |
|
| Email |
khadijeh.menai@nmims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khadijeh Menai |
| Designation |
Assistant Professor- Physiotherapy |
| Affiliation |
Sunandan Divatia school of science |
| Address |
Sunandan Divatia School of Science, SVKM Bhaktivedanta road, vile
parle west
MAHARASHTRA
400056
India |
| Phone |
9823390277 |
| Fax |
|
| Email |
khadijeh.menai@nmims.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, ground floor, Nanavati Max Super Speciality Hospital, sv road, vile
parle west |
|
|
Primary Sponsor
|
| Name |
Dr. Aishwarya Shirude |
| Address |
Sunandan Divatia School of Science SVKM Bhaktivedanta road vile
parle west |
| 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 Aishwarya Shirude |
Nanavati Max Super Speciality hospital |
department of
physiotherapy ground
floor , LIC colony, SV road, vile parle west, mumbai 400056
Mumbai (Suburban)
MAHARASHTRA |
0226172329
aishushirude@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nanavati Max Super Speciality Hospital |
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 |
| Comparator Agent |
Control group |
10 sessions in consecutive 10 days of routine protocol |
| Intervention |
Tissue Flossing technique |
10 sessions in consecutive 10 days of tissue flossing along with routine protocol |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adhesive capsulitis patients |
|
| ExclusionCriteria |
| Details |
Vascular diseases
Any recent upper limb fractures on involved side (past 6 months)
Patients with known latex allergy
Any neurological impairment
Any other musculoskeletal conditions (rotator cuff tear, bursitis) |
|
|
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 |
Visual Analog Scale(VAS)
Shoulder Range Of Motion
Shoulder Pain And Disability Index
Finger Ladder |
The outcome measures will be assessed pre and post the intervention. Pre assessment will be on 0 day and post assessment will be after 10 days of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
23/10/2023 |
| 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="0"
Months="6"
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
|
TITLE- Effects of tissue flossing on pain, range of motion and functions as an adjunct to standardized protocol in adhesive capsulitis patients
INTRODUCTION- Adhesive capsulitis is characterized by insidious onset, severe shoulder pain, usually worse at night, shoulder stiffness and loss of active and passive movements of shoulder is seen due to adhesions and scar tissue formation along with observed inflammatory and fibrotic changes in joint capsule and surrounding structures. Tissue flossing technique is a compression based technique. A special stretch rubber band is used for compression. The effects of which include improved range of motion and performance, speed up recovery and reduce pain caused by various diseases or injuries
AIM To study the effects of tissue flossing on pain, range of motion and function as an adjunct to standardized protocol in adhesive capsulitis patients
OBJECTIVES To study the effects of tissue flossing along with conventional treatment on pain, range of motion and function in adhesive capsulitis patients To study the effects of conventional treatment on pain, range of motion and function in adhesive capsulitis patients To study the effectiveness between conventional treatment and conventional treatment along with tissue flossing on pain, range of motion and function in adhesive capsulitis patients
|