| CTRI Number |
CTRI/2024/02/062932 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
To improve movement, reduce pain, sleep quality while using muscle energy technique in patients with shoulder pain |
|
Scientific Title of Study
|
Efficacy of muscle energy technique versus conventional treatment on pain, range of motion, functional disability and quality of sleep in patients with idiopathic adhesive capsulitis |
| 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 Niti Prakash |
| Designation |
Assistant Professor |
| Affiliation |
Saket College of Physiotherapy |
| Address |
Room No.67, Saket College of Physiotherapy Chandimandir, Panchkula
Panchkula
HARYANA
134107
India |
| Phone |
9501766396 |
| Fax |
|
| Email |
drnitiprakash@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shagun Bhardwaj |
| Designation |
Student, Masters in Physiotherapy(orthopedics) |
| Affiliation |
Saket College of Physiotherapy |
| Address |
College Rehabilitation Centre, Saket College of Physiotherapy Chandimandir, Panchkula
Panchkula
HARYANA
134107
India |
| Phone |
9991047899 |
| Fax |
|
| Email |
sbhardwaj8jan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shagun Bhardwaj |
| Designation |
Student, Masters in Physiotherapy(orthopedics) |
| Affiliation |
Saket College of Physiotherapy |
| Address |
College Rehabilitation Centre Room no:55, Saket College of Physiotherapy Chandimandir, Panchkula
HARYANA
134107
India |
| Phone |
9991047899 |
| Fax |
|
| Email |
sbhardwaj8jan@gmail.com |
|
|
Source of Monetary or Material Support
|
| i will myself bear the other cost required. Address shagun MPT student, Room no: 55 college rehabilitation centre Saket College of Physiotherapy, Chandimandir Panchkula
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Niti Prakash |
Saket College of Physiotherapy, Chandimandir Panchkula |
Room no:33 Mother Teresa Saket Orthopedic hospital, sector 1 Panchkula
Panchkula
HARYANA |
9501766396
sbhardwaj8jan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conservative Management |
1. Finger ladder exercises 5 repetition per set, 3sets per session
2. Capsular stretch for anterior, posterior and inferior capsule for each stretch 3 repetition, 30 second hold.
3. Self stretching exercises for 10 times with 30 second rest period in between and with 10 second hold |
| Intervention |
Muscle Energy Technique |
Muscle Energy Technique for shoulder flexion, abduction and external rotation will be performed 5 times a week for 3 weeks. For each muscle energy technique 5 repetition per set, 5 sets per session with 30 seconds rest in between. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Capsular pattern restriction
2. Idiopathic adhesive capsulitis
3. Unilateral condition
4. Having painful stiff shoulder for at least
3 months
5. Subjects with 2nd and 3rd stage of adhesive
capsulitis
|
|
| ExclusionCriteria |
| Details |
1. Presence of neurological disorders of upper
extremity
2. Rotator cuff tendinitis
3. Diabetes
4. Severe trauma related to painful stiff shoulder
5. Fracture of shoulder complex
6. Previous surgery of the shoulder |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain(numerical pain rating scale)
Range of motion(digital goniometer)
Functional disability(shoulder pain and disability index)
Sleep quality index(pittsburgh sleep quality index)
|
1. Baseline data
2. 1 week
3. 2 weeks
3. 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
01/03/2024 |
| 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)
|
Not Applicable |
| 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
|
In this study we will include efficacy of muscle energy technique versus conventional treatment in frozen shoulder patients. treatment will be given for 3weeks. Pre and post measurements will be taken on pain, range of motion, functional disability and quality of sleep in patients with adhesive capsulitis. both the group will receive conventional treatment which includes hot pack, capsular stretch, finger ladder exercises, self stretching exercises after the measurements. The data collected will be analyzed accordingly with the appropriate tests. Discussion, result, conclusion will also be written accordingly. |