| CTRI Number |
CTRI/2022/06/043391 [Registered on: 21/06/2022] Trial Registered Prospectively |
| Last Modified On: |
14/06/2022 |
| 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
|
"Effectiveness of Muscle Energy Technique versus Strain Counter Strain Technique in Carpal Tunnel Syndrome Patients" - A Prospective Comparative Study |
|
Scientific Title of Study
|
Efficacy of Muscle Energy Technique versus Strain Counter Strain Technique on pain and functional disabilities in the Individuals with Carpal tunnel syndrome â€- A Prospective Comparative Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madhavi Kandarkar |
| Designation |
Resident |
| Affiliation |
Ravi Nair Physiotherapy College , DMIMS , Sawangi |
| Address |
Department of Musculoskeletal Physiotherapy , Ravi Nair Physiotherapy College , Datta Meghe Institute of Medical Sciences , Sawangi ( Meghe Wardha)
Wardha
Maharashtra
442001
India
Ravi Nair Physiotherapy College , Datta Meghe Institute of Medical Sciences , Sawangi ( Meghe Wardha)
Wardha
Maharashtra
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
09284274112 |
| Fax |
|
| Email |
madhavi.kandarkar@dmimsu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepali Patil |
| Designation |
Associate Professor |
| Affiliation |
Ravi Nair Physiotherapy College , Datta Meghe Institute of Medical Sciences |
| Address |
Department of Musculoskeletal Physiotherapy , Ravi Nair Physiotherapy College , Datta Meghe Institute of Medical Sciences , Sawangi ( Meghe Wardha)
Wardha
Maharashtra
442001
India
Ravi Nair Physiotherapy College , Datta Meghe Institute of Medical Sciences , Sawangi ( Meghe Wardha)
Wardha
Maharashtra
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9975453662 |
| Fax |
|
| Email |
dvjphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepali Patil |
| Designation |
Associate Professor |
| Affiliation |
Ravi Nair Physiotherapy College , Datta Meghe Institute of Medical Sciences |
| Address |
Department of Musculoskeletal Physiotherapy , Ravi Nair Physiotherapy College , Datta Meghe Institute of Medical Sciences , Sawangi ( Meghe Wardha)
Wardha
Maharashtra
442001
India
Ravi Nair Physiotherapy College , Datta Meghe Institute of Medical Sciences , Sawangi ( Meghe Wardha)
Wardha
Maharashtra
442001
India
Chandrapur
MAHARASHTRA
442001
India |
| Phone |
9975453662 |
| Fax |
|
| Email |
dvjphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| RNPC, AVBRH AND Datta Meghe Institue of Medical Sciences , Sawangi , Meghe , Wardha |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institue of Medical Sciences Ravi Nair Physiotherapy College |
| Address |
Department of Musculoskeletal Physiotherapy , Ravi Nair Physiotherapy College , Datta Meghe Institute of Medical Sciences , Sawangi ( Meghe Wardha)
Wardha
Maharashtra
442001
India |
| 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 |
| Madhavi Kandarkar |
Ravi Nair Physiotherapy , aAVBRH OPD |
Department of Musculoskeletal Physiotherapy , Ravi Nair Physiotherapy College , Datta Meghe Institute of Medical Sciences , Sawangi ( Meghe Wardha)
Wardha
Maharashtra
442001
India
Wardha
MAHARASHTRA |
9284274112
madhavi.kandarkar@dmimsu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee, RNPC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M70-M79||Other soft tissue disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Muscle energy technique procedure |
MET is a technique that requires active participation of the patient . It is form of manual therapy . MET is based on two principles : autogenic inhibition and reciprocal inhibition . It uses the muscle’s own energy as isometric contractions. When a submaximal muscular contraction is followed by stretching of the same muscle, autogenic inhibition occurs, whereas reciprocal inhibition occurs when a submaximal muscular contraction is followed by stretching of the opposite muscle. Karel Lewit created post isometric relaxation, which is a technique for lowering muscular tone after a brief duration of isometric contraction at submaximal strength . It is based on the notion of autogenic inhibition .The patients in this group will be receiving the muscle energy technique alongwith the conventional physiotherapy for 2 week, 3 weekly sessions for 45 minutes each session . |
| Comparator Agent |
Strain counter strain technique procedure |
The following are the basic stages for doing strain-counter strain (SCS) in any part of the body:
1. Locate a TrP.
2. Use a pain scale to assess tenderness.
3. Lean down the patient in a comfortable position that reduces soreness at the TrP the most passively and softly as possible. First, get a basic idea of where you want to go, then fine-tune using little movement arcs. At the very least, aim for a 70% reduction in tenderness, with a goal of 100%.
4. For 90 seconds, stay in this position while keeping an eye on the patients TrP.
5. Lie the patient down in a neutral position passively.
6. Check for sensitivity at the TrP once more.
The patients in this group will be receiving the strain counterstrain alongwith the conventional physiotherapy for 2 week, 3 weekly sessions for 45 minutes each session |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Participants between age of 45-65 years with acutely affected carpal tunnel syndrome are included in the study . Both male and female are included in the study and individuals with CTS symptoms such as pain, paresthesia, tingling and/or numbness along the median nerve level in the hand (the radial side of the fourth finger and the first three radial digits). Positive Phalen, compression and Tinel’s tests were also performed on the patients.Participants willing to participate in study with the informed consent form |
|
| ExclusionCriteria |
| Details |
Participants with pronator teres Syndromes , co-occurring disorders with cervicobrachial syndrome , anterior interosseous nerve syndrome , other median nerve entrapment syndromes , and psychologically Compromised patient |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Visual Analogue Scale |
All the outcome measures assessed pre-intervention i.e. on 1st day and post-intervention i.e. on 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Goniometer The Boston
2. Questionnaire
3. Michigan hand outcome |
All the outcome measures assessed pre-intervention i.e. on 1st day and post-intervention i.e. on 4th week |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
30/06/2022 |
| 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="1"
Months="0"
Days="0" |
|
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
|
The present study intends to compare the efficacy of muscle energy technique and strain counterstrain technique efficacy in pain participants with Carpal tunnel syndrome . |