| CTRI Number |
CTRI/2021/03/031733 [Registered on: 05/03/2021] Trial Registered Prospectively |
| Last Modified On: |
04/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Yoga therapy versus Pilate’s exercises in school teachers with non-specific chronic low back pain. |
|
Scientific Title of Study
|
Clinical outcomes and psychosocial effectiveness of Yoga therapy versus Pilate’s exercises in school teachers with non-specific chronic low back pain – A randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gopal Nambi |
| Designation |
Associate Professor |
| Affiliation |
Prince Sattam Bin Abdulaziz University, KSA |
| Address |
Department of Physical Therapy and Health Rehabilitation,
College of Applied medical sciences,
Prince Sattam Bin Abdulaziz University,
Al- Kharj, Saudi Arabia.
Department of Physical Therapy and Health Rehabilitation,
College of Applied medical sciences,
Prince Sattam Bin Abdulaziz University,
Al- Kharj, Saudi Arabia.
11942
Other |
| Phone |
|
| Fax |
|
| Email |
physio_gopal@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gopal Nambi |
| Designation |
Associate Professor |
| Affiliation |
Prince Sattam Bin Abdulaziz University, KSA |
| Address |
Department of Physical Therapy and Health Rehabilitation,
College of Applied medical sciences,
Prince Sattam Bin Abdulaziz University,
Al- Kharj, Saudi Arabia.
Department of Physical Therapy and Health Rehabilitation,
College of Applied medical sciences,
Prince Sattam Bin Abdulaziz University,
Al- Kharj, Saudi Arabia.
11942
Other |
| Phone |
00966501878382 |
| Fax |
|
| Email |
physio_gopal@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gopal Nambi |
| Designation |
Associate Professor |
| Affiliation |
Prince Sattam Bin Abdulaziz University, KSA |
| Address |
Department of Physical Therapy and Health Rehabilitation,
College of Applied medical sciences,
Prince Sattam Bin Abdulaziz University,
Al- Kharj, Saudi Arabia.
Department of Physical Therapy and Health Rehabilitation,
College of Applied medical sciences,
Prince Sattam Bin Abdulaziz University,
Al- Kharj, Saudi Arabia.
11942
Other |
| Phone |
00966501878382 |
| Fax |
|
| Email |
physio_gopal@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Primary Sponsor: Prince Sattam Bin Abdulaziz University, Al- Kharj, Saudi Arabia. |
|
|
Primary Sponsor
|
| Name |
Primary Sponsor Prince Sattam Bin Abdulaziz University Al Kharj Saudi Arabia |
| Address |
Department of Physical Therapy and Health Rehabilitation,
College of Applied medical sciences,
Prince Sattam Bin Abdulaziz University,
Al- Kharj, Saudi Arabia.
|
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Saudi Arabia |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Gopal Nambi |
Prince Sattam Bin Abdul Aziz University |
Department of Physical Therapy and Health Rehabilitation,
College of Applied medical sciences,
Prince Sattam Bin Abdulaziz University,
Al- Kharj, Saudi Arabia.
|
00966501878382
physio_gopal@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M255||Pain in joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pilates Exercise |
Pelvic curl: Usually one of the first exercises taught to Pilates beginners. Shows you how to use the abdominals to lengthen and support the back. Single leg lift: An exercise that’s done with the spine in a neutral position. It’s a great exercise for patients lacking pelvic stability or core awareness. Chest lift: Helps to strengthen the abdominal muscles. Although it looks similar to a sit-up or crunch, the emphasis is on the engagement of the transversus abdominis (TrA) and pelvic stability. Supine spine twist: This exercise is great for anyone lacking spinal mobility. It helps to strengthen the oblique muscles, as well as stretch the back muscles. Shoulder bridge prep: Great for challenging lumbar stabilisation, as well as strengthening the glutes. Side bend: The side bend is good for strengthening the shoulders, back and abdominals. Basic back extension: Simple yet effective exercise for strengthening the often weak back extensor muscles. It also helps develop control of the core muscles. This exercise program will be performed 3 days a week with 5 repetitions in 3 sets with 30.seconds pauses per set to begin with and repetitions and it will gradually increase until they reach 15. The entire program will last for 8 weeks. |
| Intervention |
Yoga therapy |
The intervention consisted of 29 postures. Poses from the following categories will be used: Supine, seated, standing, forward bends, twists, and inversions. No back bending poses will be introduced at this stage of recovery to reduce the risk of re injury. Back bending poses require a proper progression of musculoskeletal retraining and can be harmful if done without implementation of complex musculoskeletal actions. Before doing yoga soft tissue flexibility and range of motion exercises will be taught to these patients with 5 - 10 min relaxation periods (warm up). The yoga program will be performed 3 days a week with 5 repetitions in 3 sets with 30.seconds pauses per set to begin with and repetitions and it will gradually increase until they reach 15. During yoga, importance of neutral spinal position will be repeatedly
stressed. The entire program will lasted for 8 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Male school teachers in the age group of 30 to 60 years, chronic ( more than 3 months) LBP and 4 to 8 pain intensity in visual analog scale (VAS) will be included. |
|
| ExclusionCriteria |
| Details |
Participants with severe musculoskeletal, neural, somatic, and psychiatric conditions, waiting for spine surgery, having alcohol or drug abuse, involving in other weight and balance training program will be excluded from the study. Participants with other soft tissue injuries, fracture at the lower limbs and pelvic bone, deformities will also be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual analog scale |
Outcomes measured at baseline, after 4 weeks, 8 weeks and at 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Range of motion
Functional disability
Muscle cross sectional area
Quality of life |
Outcomes measured at baseline, after 4 weeks, 8 weeks and at 6 months. |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="0"
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)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/03/2021 |
| 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 Applicable |
|
Publication Details
|
Will publish in Web of science (ISI) indexed journal. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Yoga and exercise interventions are usually delivered in physical
therapy clinics for treating chronic low back pain condition. It includes different postures applied
for the joints and other structures, Yoga therapy and other different forms of exercises
are delivered by various clinicians, including yoga specialists, physiotherapists,
physical therapists, chiropractors and osteopaths. The aims of both types of
interventions are to relieve pain, promote healing, reduce muscle spasms,
increase joint range, strengthen weakened muscles and improve biomechanics and
function. Hence this study is trying to find its different effects in school teachers with chronic
low back pain. |