| CTRI Number |
CTRI/2024/03/064347 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
13/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
comparison of Muscle Energy Technique with stretching and Muscle Energy Technique with Myofascial Release in patients suffering from upper cross syndrome |
|
Scientific Title of Study
|
Efficacy of Muscle Energy Technique with stretching versus Muscle Energy Technique with myofascial release in upper cross syndrome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ravita Phogat |
| Designation |
Student |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar HARYANA 125001 India |
| Phone |
9729185376 |
| Fax |
|
| Email |
ravitaphogat@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Varun Singh |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University Of Science and Technology |
| Address |
Department of physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar HARYANA 125001 India |
| Phone |
9802991664 |
| Fax |
|
| Email |
dr.varunpoonia@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Varun Singh |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University Of Science and Technology |
| Address |
Department of physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar HARYANA 125001 India |
| Phone |
9802991664 |
| Fax |
|
| Email |
dr.varunpoonia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravita Phogat BPT Student Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar |
|
|
Primary Sponsor
|
| Name |
Guru Jambheshwar University of Science and Technology |
| Address |
New Delhi-Sirsa Highway Hisar- 125001 Haryana India |
| Type of Sponsor |
Other [government University] |
|
|
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 |
| Ravita Phogat |
Guru Jambheshwar University of Science and Technology Hisar Haryana |
room no 5 Department of Physiotherapy Guru J ambheshwar University of Science and Technology Hisar Haryana Hisar HARYANA |
9729185376
ravitaphogat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of GJUST |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Muscle Energy Technique with Myofascial Release and hotpacks |
Muscle Energy Technique will be given to patients with 4 repetitions and myofascial release will be given with help of knuckles, fingers and elbow. The time duration of the treatment include 3 weeks on alternate days. |
| Comparator Agent |
Muscle Energy Technique with stretching and hotpacks |
Muscle Energy technique and stretching will be given to patients with 4 repetitions in each session. The time duration of the treatment include 3 weeks on alternate days. |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Neck pain 2. Consent to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Any neurological disorder
2. Any cardiovascular disorder
3. Any surgical history of neck
4. Uncooperative patients
5. People older than 30 years of age
6. People younger than 17 years of age. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| craniovertebral angle |
The outcomes will be assessed for 4 times at the baseline, after 1 week of treatment, after 2 weeks of treatment and after 3 weeks of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| cervical range of motion |
The outcomes will be assessed for 4 times at the baseline, after 1 week of treatment, after 2 week of treatment and after 3 week of treatment |
|
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
A comparative study on population with upper cross syndrome. Cervical pain is the most common musculoskeletal disorder which further leads to secondary complications if left untreated. Secondary complications further include upper cross syndrome. This condition most commonly affects persons with sedentary lifestyles, computer users, and people who sit in slouch positions for long periods. The prevalence of upper cross syndrome in the general population is 15 – 44% per year whereas in office workers prevalence is up to 50 to 60 %. The prevalence of upper cross syndrome among college-going students is around 48.7%. management of this condition includes manual therapy that includes stretching, strengthening, muscle energy technique, myofascial release, and postural corrective exercises. Subjects will be screened for upper cross syndrome using inclusion criteria. Informed consent will be taken for participation in the study. Participants will be allocated in two groups. Treatment protocol for group A – hot packs (10-15 minutes); muscle energy technique (4 repetitions with stretch hold for 8-10 seconds); stretching(4 repetitions stretch hold for 20 seconds). Treatment protocol for group B- hot packs (10-15 minutes); muscle energy technique(4 repetitions with stretch hold for 8-10 seconds); myofascial release( given to trigger points with the help of knuckles, fingers, or elbow). Treatment will be given for 3 weeks on alternate days. Data would be recorded 4 times including at day 0, at the end of the 1st week, at the end of the 2nd week, and at the end of the 3rd week. |