| CTRI Number |
CTRI/2023/07/055126 [Registered on: 12/07/2023] Trial Registered Prospectively |
| Last Modified On: |
11/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of PRT and MFR technique in treating myofascial trigger points in upper trapezius muscle among medical students |
|
Scientific Title of Study
|
Positional Release Technique versus Myofascial Release Technique in Management of Active Trigger Points in Upper Trapezius Among Medical Students |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1292-8483 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rubi Yadav |
| Designation |
MPT student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Department of physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University,
Mullana
Ambala
HARYANA
133207
India
Ambala
HARYANA
133207
India |
| Phone |
7310279577 |
| Fax |
|
| Email |
rubyrajjan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Sharma |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Department of physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University,
Mullana
Ambala
HARYANA
133207
India
Ambala
HARYANA
133207
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita Sharma |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Department of physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University,
Mullana
Ambala
HARYANA
133207
India
Ambala
HARYANA
133207
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Orthopaedic Physiotherapy Research Lab, Maharishi Markandeshwar Institute of
Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to eb University), Mullana,
Ambala, Haryana, 133207 |
|
|
Primary Sponsor
|
| Name |
Rubi Yadav |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and
Rehabilitation, Maharishi Markandeshwar (Deemed to eb University),
Mullana, Ambala, Haryana, 133207 |
| Type of Sponsor |
Other [self ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| sunita sharma |
Maharishi Markandeshwar Institute of Physiotherapy and
Rehabilitation, Maharishi Markandeshwar (Deemed to eb University),
Mullana, Ambala, Haryana, 133207 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rubi Yadav |
Maharishi Markandeswar Super Speciality hospital |
Orthopaedics physiotherapy research lab, Maharishi
Markandeshwar
Institute of
Physiotherapy and
Rehabilitation, Maharishi
Markandeshwar
deemed to be University
Ambala
HARYANA
Ambala
HARYANA |
7310279577
rubyrajjan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, MMISR, Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Upper Trapezius Trigger Points |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Myofascial Release |
Therapist applied pressure for 10 sec to the opposite side of rotation. MFR on upper trapezius will be repeated 5 times for each session along with conventional treatment (cryotherapy and static stretching).
Intervention will be given for 3 days a week for 2 weeks |
| Intervention |
Positional Release Technique |
The therapist passively sustained for 90 seconds patient’s shoulder in the abduction position. With a 20 sec rest period in between each repetition, this will be done three times for each treatment along with conventional treatment (cryotherapy and static stretching).
Intervention will be given for 3 days a week for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
32.00 Year(s) |
| Gender |
Both |
| Details |
Medical students experiencing neck pain due to trigger points presence of maximum of one or more than one active myofascial trigger points in upper trapezius muscle |
|
| ExclusionCriteria |
| Details |
Previous history of trauma or fracture of cervical spine
PIVD at cervical region
Any inflammatory pathology, neurological impairment and cervical Tumour
Neck deformities like scoliosis or torticollis
Signs of radiculopathy or myopathy
Cervical spine surgery
Patients who received pharmacological treatment and any other type of management (acupuncture acupressure, dry needling etc.)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numerical Pain Rating Scale(NPRS)
Pressure Pain Threshold(PPT)
|
Assessment will be done with outcome measures at baseline & post intervention that is after 2 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Neck disability index(NDI)
36-Item Short Form Questionnaire (SF-36) |
Assessment will be done with outcome measures at baseline & post intervention that is after 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 4 |
|
Date of First Enrollment (India)
|
25/07/2023 |
| 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
|
This study aims to compare the effect of positional release technique and myofascial release technique along with static stretching in medical students with active trigger points in upper trapezius muscle. It is a two group pre-test-post-test group design, randomised clinical trial. Based on the inclusion criteria subjects from 18 to 24 year will be recruited. Consent to participate in the study shall be confirmed by filling the consent form by all students. Participants will be divided in to two groups: Group A- Positional Release Technique (PRT) + Static Stretching and Group B- Myofascial Release (MFR) + Static Stretching. Treatment will be given for 3 days a week for four weeks. Baseline measurement will be taken by Numerical Pain Rating Scale (NPRS) used to assess pain, Pain Pressure Threshold (PPT) used to assess tenderness, Neck Disability Index (NDI) used to assess neck disability and SF-36 used to assess quality of life of the patients. |