| CTRI Number |
CTRI/2022/10/046258 [Registered on: 07/10/2022] Trial Registered Prospectively |
| Last Modified On: |
15/09/2023 |
| 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
|
Compairing the effects of post isometric relaxation vs reciprocal inhibition technique on pain, range of motion, function and quality of life in post operative elbow stiffness |
|
Scientific Title of Study
|
Effects of post isometric relaxation and reciprocal inhibition muscle energy techniques on pain, ROM, function and quality of life in post operative elbow stiffness: A comparative study |
| Trial Acronym |
MET |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sheetal Agrawal |
| Designation |
Postgraduate student |
| Affiliation |
Sancheti Institute College Of Physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy, 11/12,Thube park, Shivajinagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
7558415832 |
| Fax |
|
| Email |
sheetalagrawal1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venu Mohan |
| Designation |
Associate Professor,Musculoskeletal department. |
| Affiliation |
Sancheti Institute College Of Physiotherapy |
| Address |
Musculoskeletal department, Sancheti Institute College of Physiotherapy,1st floor, 11/12,Thube park, Shivajinagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
9440690707 |
| Fax |
|
| Email |
venumohan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venu Mohan |
| Designation |
Associate Professor,Musculoskeletal department. |
| Affiliation |
Sancheti Institute College Of Physiotherapy |
| Address |
Musculoskeletal department, Sancheti Institute College of Physiotherapy,1st floor, 11/12,Thube park, Shivajinagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
9440690707 |
| Fax |
|
| Email |
venumohan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sancheti Institute College of Physiotherapy |
| Address |
11/12 Thube park Shivajinagar, Pune - 411005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sheetal Agrawal |
Sancheti institute of orthopaedics and rehabilitation |
Ground floor, Physiotherapy department, Shivajinagar, Pune.
Pune
MAHARASHTRA |
7558415832
sheetalagrawal1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sancheti Institute College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Post isometric relaxation muscle energy technique along with institution based treatment |
Post isometric relaxation muscle energy technique will be given for improving elbow flexion and extension range of motion in postoperative elbow stiffness patient immobilized for 3-5 weeks post operatively(technique will be given 3 times a week for 3 weeks) |
| Comparator Agent |
Reciprocal inhibition muscle energy technique along with institution based treatment |
Reciprocal inhibition muscle energy technique will be given for improving elbow flexion and extension range of motion in postoperative elbow stiffness patient immobilized for 3-5 weeks post operatively(technique will be given 3 times a week for 3 weeks) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with post operative elbow stiffness immobilized for 3 weeks
2. Between the age group of 18 - 50 year
3. Range of motion of elbow flexion restricted to less than 120 and extension greater than 30
4. Subjects understanding English language |
|
| ExclusionCriteria |
| Details |
1. Subjects who have pathological fracture
2. Subjects who have undergone for revision surgeries
3. Subjects with associated ipsilateral injuries
4. Any neuro vascular disorders
5. Dislocated fractures
6. Subjects with associated soft tissue injuries |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain(Visual Analogue Scale)
2.ROM (universal half goniometer)
3.Function( patient rated elbow evaluation scale)
4.Quality of life(Musculoskeletal health Questionnaire) |
At the initiation of study and at the end of 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/10/2022 |
| Date of Study Completion (India) |
22/08/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
“none yet†|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
we have analyzed the effects of post isometric relaxation and reciprocal inhibition, muscle energy techniques on pain, range of motion ,function and quality of life in post operative elbow stiffness. Subjects were randomly divided into two groups, group I received post isometric relaxation muscle energy technique and group II received reciprocal inhibition muscle energy technique ,conventional exercise protocol and home exercise program was common for both groups. Both the techniques of MET, PIR and RI can be safely administered and are found to have significant
effect in terms of reducing pain, improving ROM, function and quality of life in post operative elbow
stiffness subjects. Whereas in, between group comparison both the techniques are found to have
comparable effects and can be used as an adjunct to the conventional rehabilitation protocol in the early
stages of rehabilitation for post- operative elbow fracture cases managed surgically with open reduction
and rigid internal fixation. |