| CTRI Number |
CTRI/2022/04/041579 [Registered on: 01/04/2022] Trial Registered Prospectively |
| Last Modified On: |
31/03/2022 |
| 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
|
Comparing effect between percussion gun and IASTM on superficial layer of hamstrings and low back region in people with non specific lower back pain: a randomized parallel group study. |
|
Scientific Title of Study
|
Comparative Effect of Mechanical Muscle Percussion and IASTM on Hamstring and Thoracolumbar Facia in Individuals with Non-specific Low Back Pain: A Randomized Parallel Group Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jaytie Parki |
| Designation |
Post Graduate student |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
Department of Orthpaedic Physiotherapy
KAHER Institute of Physiotherapy
JNMC Campus Nehru Nagar
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9167653164 |
| Fax |
|
| Email |
jaytieparki@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aarti Welling |
| Designation |
Assistant Professor |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
Department of Orthpaedic Physiotherapy
KAHER Institute of Physiotherapy
JNMC Campus Nehru Nagar
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9448814569 |
| Fax |
|
| Email |
aartiwell88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jaytie Parki |
| Designation |
Post Graduate student |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
Department of Orthpaedic Physiotherapy
KAHER Institute of Physiotherapy
JNMC Campus Nehru Nagar
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9167653164 |
| Fax |
|
| Email |
jaytieparki@yahoo.com |
|
|
Source of Monetary or Material Support
|
| KAHER Institute of physiotherapy |
|
|
Primary Sponsor
|
| Name |
KAHER institute of physiotherapy |
| Address |
KAHER institute of physiotherapy, NEHRU NAGAR, BELGAUM, KARNATAKA.
Belgaum
KARNATAKA
590001
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Jaytie Parki |
KAHER Institute of physiotherapy |
Department of orthopedic physiotherapy, KAHER Institute of physiotherapy, Nehru nagar
Belgaum
KARNATAKA |
9167653164
jaytieparki@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER Institute of physiotherapy research and ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M709||Unspecified soft tissue disorder related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Instrument-Assisted Soft-Tissue Mobilization (IASTM) |
IASTM will be applied parallel and perpendicular to these sites for 20 seconds, each time.
Dosage – 9 sessions: 3 sessions in a week
|
| Intervention |
Percussion gun |
It will be applied bilaterally for 5 to 7 minutes each side.
Dosage – 9 sessions: 3 sessions in a week
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1)Individuals of all genders in the age group of 18-55years with lower back pain for at least 3 months.
2)Individuals with any flexion recorded more than 20 degrees being tested positive in Active knee Extension Test.
3)Individuals willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Participants with pathology such as infection, malignancy, inflammatory disease, structural deformity, history of trauma at abdominal or lumbar region, abdominal or lumbar surgery or pregnancy (suspected or confirmed).
Subjects with neurological deficit (paraesthesia, sensory loss, radiculopathy, myelopathy)
Any mental illness (Dementia, Alzheimer’s, Parkinson disease etc.)
Subjects on medications like corticosteroids, antidepressants, anti-inflammatory medications.
Peripheral vascular disease
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Active knee extenion test
2.Visual Analouge scale
3.Postural sway |
At baseline and week three |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| no secondary outcomes |
0 |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
05/04/2022 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Participant selection will be done as per the Inclusion and Exclusion Criteria. A
written informed consent will be obtained from the participants.
And all the covid
19 precautions will be taken according to ICMR guidelines.
A
brief demographic data and baseline outcome measures (Active knee extension test, Visual analogue scale, Sit and reach test, Postural Sway) will be obtained from the
subjects. Participants will be equally divided into two groups. Group A will be given IASTM and Group B will be given Percussion gun along with conventional treatment. Post intervention outcome measures will be assessed.
|