| CTRI Number |
CTRI/2022/12/048010 [Registered on: 12/12/2022] Trial Registered Prospectively |
| Last Modified On: |
09/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Instrument Assisted Soft Tissue Mobilization Technique in De Quervain’s Disease |
|
Scientific Title of Study
|
Effectiveness of Instrument Assisted Soft Tissue Mobilization Technique in De Quervain’s Disease–A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RANU APEXA RAJESHKUMAR |
| Designation |
BPT Intern |
| Affiliation |
Nootan College of Physiotherapy, Sankalchand Patel University, Visnagar. |
| Address |
OPD-1, Orthopedic Department, Nootan College of Physiotherapy, Sankalchand Patel University, Visnagar.
Mahesana
GUJARAT
384315
India |
| Phone |
6354654769 |
| Fax |
|
| Email |
arranu434@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivani Patel |
| Designation |
Tutor |
| Affiliation |
Nootan College of Physiotherapy, Sankalchand Patel University, Visnagar. |
| Address |
OPD-1, Orthopedic Department, Nootan College of Physiotherapy, Sankalchand Patel University, Visnagar.
Mahesana
GUJARAT
384315
India |
| Phone |
9624692121 |
| Fax |
|
| Email |
dr.srp12345.sp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RANU APEXA RAJESHKUMAR |
| Designation |
BPT Intern |
| Affiliation |
Nootan College of Physiotherapy, Sankalchand Patel University, Visnagar. |
| Address |
OPD-1, Orthopedic Department, Nootan College of Physiotherapy, Sankalchand Patel University, Visnagar.
Mahesana
GUJARAT
384315
India |
| Phone |
6354654769 |
| Fax |
|
| Email |
arranu434@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nootan College of Physiotherapy, Sankalchand Patel University, Visnagar, 384315 |
|
|
Primary Sponsor
|
| Name |
RANU APEXA RAJESHKUMAR |
| Address |
OPD-1, Orthopedic Department, Nootan College of Physiotherapy, Sankalchand Patel University, Visnagar, 384315. |
| 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 |
| RANU APEXA RAJESHKUMAR |
Nootan College of Physiotherapy. |
OPD-1, Orthopedic Department, Nootan College of Physiotherapy, Sankalchand Patel University, Visnagar,384315.
Mahesana
GUJARAT |
6354654769
arranu434@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The institutional Ethics committee of Nootan College of Physiotherapy , Sankalchand Patel University ,Visnagar, 384315. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M654||Radial styloid tenosynovitis [de Quervain], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Instrument Assisted Soft Tissue Mobilization (IASTM).
|
IASTM Treatment plan - 3 sets for 3min/day, and 5 sessions/week for 3 weeks,
Total – 15 sessions.
|
| Comparator Agent |
Numerical pain rating scale (NPRS), Patient-Rated Wrist Evaluation , Goniometer (Smart protractor App). |
Numerical pain rating scale (NPRS) to assess intensity of pain, Patient-Rated Wrist Evaluation to assess the functional mobility of Wrist, Goniometer (Smart protractor App) to assess the range of motion of Wrist. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Participants with positive Finkelstein’s test,
Chronic condition,
Participants who are willing to be part of the study. |
|
| ExclusionCriteria |
| Details |
Participants with carpal tunnel syndrome,
Participants with any arthritic changes like Rheumatoid arthritis,
Participants with any fracture and deformity in wrist,
Participants with radiating pain and other neurological signs,
Pregnancy,
Prior surgery for de quervain’s disease.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numerical pain rating scale (NPRS),
Patient-Rated Wrist Evaluation ,
Goniometer(Smart protractor App).
|
Numerical pain rating scale (NPRS),
Patient-Rated Wrist Evaluation,
Goniometer (Smart protractor App).
These all outcome measures will be assessed before the treatment began and after completion of the 3 weeks of IASTM treatment session again all outcomes will be re-assessed.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
12/12/2022 |
| 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="0"
Days="21" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
TITLE- Effectiveness of Instrument Assisted Soft Tissue Mobilization Technique in De
Quervain’s Disease–A Randomized Controlled Trial INVESTIGATOR NAME - RANU APEXA RAJESHKUMAR (BPT INTERN) ,Nootan College of Physiotherapy, Sankalchand Patel University, Visnagar, 384315. AIM - The aim of this study is to find out the effectiveness of the Instrument assisted soft tissue
mobilization in De Quervain’s Disease. OBJECTIVES - To decrease pain, To improve range of motion, To restoring proper function, To compare the experimental group to the control group. MATERIALS - Assessment Form Consent Form Goniometer (Smart protractor app) Functional outcome index Instrument assisted soft tissue mobilization tool Pen & paper Pillow Laptop Chair PROCEDURE The research will be done after approved by the ethics committee of Nootan Collage
of Physiotherapy, Sankalchand Patel University, Visnagar. First, all participants will
be educated about the study processes and the participants will be asked to give their
written consent and permit participation in this study. The study population will consist of 30 participants who had De Quervain’s
Tenosynovitis. The participants will randomly be allocated into two groups: an experimental group
(n-15) and a control group (n-15). The physical characteristics of the all participants will recorded at the outset of the
study. The participants who will allocated to the experimental group will receive IASTM
treatment |