| CTRI Number |
CTRI/2022/08/044925 [Registered on: 25/08/2022] Trial Registered Prospectively |
| Last Modified On: |
24/08/2022 |
| 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
|
Effects of High velocity, low amplitude thrust (HVLT) technique on individuals who have Non specific low back pain. |
|
Scientific Title of Study
|
Effects of High Velocity, Low Amplitude Thrust on Postural sway, Pain and Functional disability in individuals with chronic non-specific low back pain. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not Applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mitsu Desai |
| Designation |
Resident |
| Affiliation |
Dr. D. Y. Patil college of physiotherapy |
| Address |
MPT-2 classroom, 3rd floor, Left side to Kinesiology department, Dr. D. Y. Patil College of Physiotherapy, Sant tukaram Nagar, Pimpri, Pune. 411018
Kinesiology Department, 3rd floor, right side to MPT-1 classroom, Dr. D. Y. Patil college of Physiotherapy, Pimpri, Pune. 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7874372885 |
| Fax |
|
| Email |
mitsudesai18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mitsu Desai |
| Designation |
Resident |
| Affiliation |
Dr. D. Y. Patil college of physiotherapy |
| Address |
MPT-2 classroom, 3rd floor, Left side to Kinesiology department, Dr. D. Y. Patil College of Physiotherapy, Sant tukaram Nagar, Pimpri, Pune. 411018
Kinesiology Department, 3rd floor, right side to MPT-1 classroom, Dr. D. Y. Patil college of Physiotherapy, Pimpri, Pune. 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7874372885 |
| Fax |
|
| Email |
mitsudesai18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mitsu Desai |
| Designation |
Resident |
| Affiliation |
Dr. D. Y. Patil college of physiotherapy |
| Address |
MPT-2 classroom, 3rd floor, Left side to Kinesiology department, Dr. D. Y. Patil College of Physiotherapy, Sant tukaram Nagar, Pimpri, Pune. 411018
Kinesiology Department, 3rd floor, right side to MPT-1 classroom, Dr. D. Y. Patil college of Physiotherapy, Pimpri, Pune. 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7874372885 |
| Fax |
|
| Email |
mitsudesai18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil physiotherapy OPD., Ground Floor, Dr. D. Y. Patil college of physiotherapy, Pimpri, Pune |
|
|
Primary Sponsor
|
| Name |
Mitsu Desai |
| Address |
MPT-2 classroom, 3rd floor, Left side of kinesiology dept, Dr. D. Y. Patil college of Physiotherapy, Sant tukaram nagar, pimpri, pune |
| Type of Sponsor |
Other [self] |
|
|
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 |
| DrDivya Gohil |
Dr. D. Y. Patil college of Physiotherapy |
Kinesiology Department, 3rd floor, Right side cabin to MPT-1 classroom, Dr. D. Y. Patil College Of Physiotherapy, Pimpri, Pune. 411018
Pune
MAHARASHTRA |
7767828290
divya.gohil@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee - Dr. D. Y Patil college of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non-Specific Low Back Pain |
| Patients |
(1) ICD-10 Condition: Z781||Physical restraint status, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Core stability Exercises. |
It will be given for 14 days. i.e. 2 weeks. Core stability mainly focuses on strengthning of core muscles and back muscles which has been proved to reduce low back pain in individuals with chronic non specific low back pain. |
| Intervention |
High velocity, Low amplitude thrust. |
It will be given thrice in 14 days intervention. This mechanism of action enables the vertebral segments to progress in a bigger range of motion and would diminish the mechanical pressure on paraspinal muscles, thus reducing pain and distress. |
| Comparator Agent |
Not Applicable |
Not Applicabl |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Young and middle aged adults between age group 18-60 years16having chronic low back.(more than 3 months)
2. Hypomobility of lumbar spine.
3. NPRS severity of 3-7 with mild and moderate pain level.
|
|
| ExclusionCriteria |
| Details |
1. Contraindications to spinal manipulation such as recent fractures, infections and spinal deformities.
2. Individuals undergone joint replacement surgeries.(hip and knee)
3. Individuals with (grade 3) OA of hip, knee.
4. Spondylolisthesis.
5. Mechanical low back pain.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postural Sway will be assessed using Neuro-com BALANCE MASTER |
Assessed at the first and then the last day of the intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain |
With NPRS scale at the first day and the last day of intervention. |
| Functional Disability |
Modified Oswestry Disability Index at the beginning and the last day of the intervention. (On the first day and the last day) |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
31/08/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The current research will be done to study and evaluate whether applying high velocity, low amplitude thrust to the lumbar spine helps in improving postural sway and hence balance thereby reducing pain and improving functional disabilities in individuals with chronic non specific low back pain, also whether the technique can be implicated in routine practice along with exercise therapy and other management guidelines. Our back is complex and multi joint region which has various structures that can cause pain and this can be recognized based on location of pain. This mechanism of action enables the vertebral segments to progress in a bigger range of motion and would diminish the mechanical pressure on paraspinal muscles, thus reducing pain and distress. 20 subjects will receive spinal manipulation i.e. High velocity, low amplitude thrust, to the lumbar spine twice a week along with core stability exercises. 20 subjects will receive conventional exercises- core stability exs. |