| CTRI Number |
CTRI/2024/03/064401 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of exercise with laser in myofascial pain syndrome |
|
Scientific Title of Study
|
Efficacy of post isometric relaxation technique in combination with laser in subjects with myofascial pain syndrome: a randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyoti |
| 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 |
7082546572 |
| Fax |
|
| Email |
tokasjyoti84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Boora PT |
| 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 |
8683810061 |
| Fax |
|
| Email |
mamtaboora50@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Boora PT |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of physiotherapy Guru Jambheshwar University of Science and Technology Hisar
HARYANA
125001
India |
| Phone |
8683810061 |
| Fax |
|
| Email |
mamtaboora50@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jyoti Tokas BPT Student Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar |
|
|
Primary Sponsor
|
| Name |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of physiotherapy Guru Jambheshwar University of Science and Technology Hisar |
| Type of Sponsor |
Research institution |
|
|
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 |
| Jyoti tokas |
Department of Physiotherapy GJUST |
Room No 5 OPD Department of Physiotherapy Guru Jambheshwar University of Science and Technology
Hisar
HARYANA |
7082546572
tokasjyoti84@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: M70-M79||Other soft tissue disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Post isometric relaxation exercise with hotpack |
Patient in this group will perform post isometric relaxation exercise and hotpack will be given for 4 weeks |
| Intervention |
Post isometric relaxation exercise with LASER and hotpacks |
Patients in this group will perform post isometric relaxation exercise for 4 weeks and LASER will be given twice a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18 to 50 years.
2.Both Males and Females.
3.Patients with active or palpable Myofascial Trigger Points on one or both sides of the upper back (trapezius muscles).
4.Consent to participate in study. |
|
| ExclusionCriteria |
| Details |
1.CNS deficit patients.
2.Cognitive deficit patients.
3.Patients receiving some other treatment like dry needling, acupuncture injections etc.
4.Uncooperative patients. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cervical lateral flexion range of motion,
Shoulder range of motion,
Northwick Park neck pain questionnaire |
The outcomes will be assessed for two times which is at the baseline and after the 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tenderness grading scale |
The outcome will be assessed for two times which is at the baseline and after the 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1 |
|
Date of First Enrollment (India)
|
30/03/2024 |
| 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="0"
Months="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
It is a randomized controlled trial with a duration of 4 weeks and involving 40 patients that will be divided into two groups based on the lottery method. Its intervention involves post isometric relaxation exercise with laser and hot pack in one group and post isometric relaxation exercise with hot pack in control group. The patients will be informed about the study and written informed consent will be taken. First, each patient’s demographic information including age, height and weight will be gathered as a baseline data. Pre-intervention measurements of outcome variables including cervical lateral flexion range of motion, shoulder range of motion, tenderness grading scale, Northwick park neck pain questionnaire will be taken. Interventions will be given for 4 weeks then Post-intervention data of all outcome variables will taken. |