| CTRI Number |
CTRI/2024/04/065991 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| 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
|
Myofascial Gun Therapy: Efficacy on Low Back Pain and Flexibility in People with Sedentary Standing Jobs |
|
Scientific Title of Study
|
Effect of Myofascial Release Using Myofascial Gun on Thoracolumbar fascia for Pain and Flexibility in People with Sedentary Standing Jobs having Low Back Pain. |
| 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 Harshita Gupta |
| Designation |
PG student |
| Affiliation |
MAEERs College of Physiotherapy Talegaon Dabhade |
| Address |
Room no. A-207 Musculoskeletal physiotherapy department 2nd floor, OPD Building, MAEERs College of Physiotherapy, Near Talegaon Railway Station, Talegaon Dabhade
Pune
MAHARASHTRA
410507
India |
| Phone |
8828095620 |
| Fax |
|
| Email |
harshita27gupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Snehal Ghodey |
| Designation |
Principal |
| Affiliation |
MAEERs College of Physiotherapy Talegaon Dabhade |
| Address |
Room no. A-207 Musculoskeletal physiotherapy department 2nd floor, OPD Building, MAEERs College of Physiotherapy, Near Talegaon Railway Station, Talegaon Dabhade
Pune
MAHARASHTRA
410507
India |
| Phone |
9422326959 |
| Fax |
|
| Email |
gsnehavi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Snehal Ghodey |
| Designation |
Principal |
| Affiliation |
MAEERs College of Physiotherapy Talegaon Dabhade |
| Address |
Room no. A-207 Musculoskeletal physiotherapy department 2nd floor, OPD Building, MAEERs College of Physiotherapy, Near Talegaon Railway Station, Talegaon Dabhade.
Pune
MAHARASHTRA
410507
India |
| Phone |
9422326959 |
| Fax |
|
| Email |
gsnehavi@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAEERs College of Physiotherapy Talegaon Dabhade |
|
|
Primary Sponsor
|
| Name |
MAEERs College of Physiotherapy Talegaon Dabhade |
| Address |
MAEERs College of Physiotherapy
2nd Floor, OPD Building, near Talegaon Railway Station, Talegaon Dabhade-410507
|
| Type of Sponsor |
Private medical college |
|
|
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 Snehal Ghodey |
MAEERs Collee of Physiotherapy Talegaon Dabhade |
2nd Floor, OPD Building, near Talegaon Railway Station, Talegaon Dabhade-410507
Pune
MAHARASHTRA |
9422326959
gsnehavi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAEERs Collee of Physiotherapy Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Therapy |
TENS therapy for 15 minutes
DLF stretching- 30 seconds hold for 3 repetitions
MFR to thoracolumbar fascia- 60 seconds for 3 repetitions
Core Strengthening exercises
Lower Limb Strengthening exercises will include SLR with holds in all 3 planes. The protocol will be given for 7 consecutive sessions. |
| Intervention |
Myofascial Release Gun with Conventional Therapy |
Myofascial Release using Myofascial Gun over Thoracolumbar fascia for for 30-45seconds twice on the fascia starting from Level-1 of the frequency progressing to Level-6 till the end of the protocol.
TENS therapy for 15 minutes
DLF stretching- 30 seconds hold for 3 repetitions
MFR to thoracolumbar fascia- 60 seconds for 3 repetitions
Core Strengthening exercises
Lower Limb Strengthening exercises will include SLR with holds in all 3 planes
The protocol will be given for 7 consecutive sessions.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
People having chronic low back pain i.e. pain since the past 3 months or more.
People with sedentary standing jobs (standing duration≥28 hours per week)
People with sedentary standing jobs for 6 months or more
|
|
| ExclusionCriteria |
| Details |
People having any serious spinal pathology or infections e.g. TB of spine
Any open wounds or recent surgery on the low back.
People having any congenital spinal conditions.
People with recent trauma to low back in the last 6 months.
People having radiating low back pain.
Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Spine flexion flexibility |
Baseline and 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain using Pain Algometer |
0 day & 7th day |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/05/2024 |
| 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="6"
Days="0" |
|
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
|
Background-The occurrence of low back pain in India is
alarming with nearly 60% of the people in India have suffered from low back
pain at some time during their lifespan. Low back pain also restricts mobility,
interferes with normal functioning and results in lifelong pain and permanent
disability. This study investigates the effect that a myofascial gun can have
on pain and range of motion of low back in a working person in a standing job
after a week-long intervention. Methodology-Thirty-six participants will be
randomly allocated into Group A or Group B through chit allocation with
replacement method. Baseline
results will be taken for pain using pain algometer and for flexibility using
modified modified Schober’s test on Day-1.
Conventional physiotherapy will be given
to Group A. For Group B, conventional physiotherapy treatment will be given
along with application of the MFR gun over the thoracolumbar fascia.
Post-interventional results will be taken on Day-7.
Data
will be collected, analysed and compared. |