| CTRI Number |
CTRI/2024/05/067326 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Effects of yoga on feedforward activation and feedback postural control mechanism in non specific low back pain |
|
Scientific Title of Study
|
Effects of yoga on Feed forward Activation and Feedback Postural Control Mechanism on Electromyography in non-specific low back pain: A randomised 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 |
Prachi Manohar Arora |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
Musculoskeletal department, 3rd floor,Dr. Patil college of physiotherapy, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8669661804 |
| Fax |
|
| Email |
prachiaroraa99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopa Desai |
| Designation |
Associate Professor |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
Musculoskeletal department, 3rd floor,Dr. Patil college of physiotherapy, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9890992383 |
| Fax |
|
| Email |
roopa.desai@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roopa Desai |
| Designation |
Associate Professor |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
Musculoskeletal department, 3rd floor,Dr. Patil college of physiotherapy, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9890992383 |
| Fax |
|
| Email |
roopa.desai@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y.Patil college of physiotherapy,sant tukaram nagar, pimpri chinchwad,Pune, Maharshtra, India 411018
Prachi Arora |
|
|
Primary Sponsor
|
| Name |
Prachi Arora |
| Address |
Musculoskeletal department,3rd floor,Dr. D.Y.Patil college of physiotherapy, pipri |
| 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 |
| Prachi Arora |
Dr. D.Y. Patil College of Physiotherapy |
Musculoskeletal department of Dr. D.Y.Patil college of physiotherapy, Sant Tukaram nagar, pimpri,pune
Pune
MAHARASHTRA |
8669661804
prachiaroraa99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee of Dr. D.Y. Patil college of physiotherapy |
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 treatment |
Pelvic tilt
Knees to chest
Trunk flexion
Cat n camel
Semi sit up
Hip stretches
(0-3 weeks : 5 repetations with 10 sec hold )
(3-6 weeks : 2 repetatations with 30 seconds hold) |
| Intervention |
Yoga protocol |
Tadasana
Uttasana
Trikonasana
saral Bhujangasana
Ardh shalabhasana
setubadhasana (stage 1)
Ardh padma paschimottanasana
Shavasana
(0-3 weeks : 3-5 reps with 10 sec hold )
(3-6 weeks : 2 reps with 30 sec hold) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Subjects willing to participate.
Subjects referred by orthopedics to OPD with non specific low back pain
Experiencing back pain since minimum 3 months
Age (20-40 years)
Both male and females with non specific low back pain.
|
|
| ExclusionCriteria |
| Details |
Subjects with present traumatic conditions.
Subjects fulfilling non specific low back pain criteria.
Subjects with congenital disorders
Subjects with disorders, where range of motion is affected of dominant shoulder joint.
Subjects with history of fractures or spinal surgery since 1 year.
Spinal pathologies (PIVD, spinal structural deformity)
Neurological conditions.(stroke, parkinsonism.)
Pregnancy
Lower limb deformities.
Obesity grade 3 |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Electromyography
iphone level inclinometer |
PRE - 0 Weeks
POST - 6 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
30/05/2024 |
| 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="8"
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
|
Low back pain is an important health problem and general health issues that present society is facing. Non-specific low back pain is caused by prolonged hours of standing, sitting with awkward posture, bending forward, lifting heavy weights, etc. low back pain is characterized as a pain from 12th rib to the buttocks. Feedforward activation is defined as the onset of core muscle before or within 50 ms during any activity and after 50 ms it is feedback activation. Patients with LBP are likely to present with reduced lumbo-sacral position sense (disrupted feedback) and delayed contraction of transverse abdominis (altered feedforward postural control).Yoga is a medical discipline that has its roots in ancient India and is intends to treat a variety of aliments. Studies have confirmed that yoga helps in strengthning of core muscles and increases trunk stability. The core muscles are involved in trunk stability. Due to weakness and delayed activation of the core muscles, research studies confirm that there are changes in the recruitment timings and recruitment patterns after giving perturbations.Also, feedback postural control mechanism is affected in patients with NSLBP. Literature confirms that yoga helps in stabilization of spine by strengthening of the core muscles. A lot of literature regarding effects of yoga on improving strength, flexibility, endurance, breathing pattern in patients with non specific low back pain. But there is dearth in literature regarding the efficacy of yoga on feedforward activation and feedback postural control mechanism. Therefore, there is need to study and find out effects of yoga on feedforward activation and feedback postural mechanism in non specific low back pain. |