| CTRI Number |
CTRI/2024/11/076568 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the Effects of Yoga Asanas and Exercise Therapy on Knee Osteoarthritis |
|
Scientific Title of Study
|
Comparison between effect of select yoga asana with exercise therapy in osteoarthritis of knee joint |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akoijam Ravi |
| Designation |
Physical Instructor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Department of Physical Education, RIMS, Imphal, Manipur
Department of Physical Education, RIMS, Imphal, Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
9612153033 |
| Fax |
|
| Email |
ravz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Laimujam Sobhasini Devi |
| Designation |
Senior Resident |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Department of Sports Medicine, RIMS, Imphal, Manipur
Department of Sports Medicine, RIMS, Imphal, Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
8732030087 |
| Fax |
|
| Email |
sobhasinil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Laimujam Sobhasini Devi |
| Designation |
Senior Resident |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Department of Sports Medicine, RIMS, Imphal, Manipur
Department of Sports Medicine, RIMS, Imphal, Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
8732030087 |
| Fax |
|
| Email |
sobhasinil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physical Medicine and Rehabilitation, RIMS, Imphal, Manipur, India
Pin No. 795004 |
|
|
Primary Sponsor
|
| Name |
Regional Institute of Medical Sciences Imphal Manipur |
| Address |
Regional Institute of Medical Sciences, Imphal, Manipur
Pin No. 795004 |
| Type of Sponsor |
Government 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 |
| Akoijam Ravi |
RIMS Hospital, Imphal, Manipur |
Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal West District, Manipur
Pin No. 795004
Imphal West
MANIPUR |
9612153033
ravz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board RIMS Regional Institute OF Medical Sciences Lamphelpat Imphal Manipur 795004 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Physiotherapeutic exercises |
Quadriceps and hamstring strengthening exercises + Balance training + Tab. Paracetamol 500mg twice daily for 7 days |
| Intervention |
Yoga asanas |
Select Yoga asana like Mountain Pose, Warrior II, Bound angle, staff pose + Tab. Paracetamol 500mg twice daily for 7 days |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects in the age group 45-65 years who fulfilled ACR criteria for the diagnosis of the Osteoarthritis of the knee.
KL grading I-III.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with bilateral Osteoarthritis of knee
2. Secondary osteoarthritis of knee following trauma, inflammatory and metabolic arthritis
3. Subjects with uncontrolled diabetes, cardiovascular and pulmonary diseases
4. Subjects who received intra-articular steroid injection to the knee joint within 3 months
5. BMI more than 30
6. Professional squatters
7. KL grading four in X-ray
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain by using VAS score
2. WOMAC – pain, stiffness and quality of life |
3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
COOS scoring
5 sit up (time in second)
6 minute walk test (distance in meter)
|
3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/12/2024 |
| 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)
|
Open to Recruitment |
| 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
|
Objective: To compare the effectiveness of yoga asanas (Mountain Pose, Warrior II, Bound Angle, Staff Pose) versus therapeutic exercises (quadriceps/hamstring strengthening, balance training) on knee osteoarthritis (OA) pain, function, and quality of life.Design: Randomized control trial with 70 patients (aged 45-65) with grade I-III knee OA.GroupsGroup A: Yoga asanas + ParacetamolGroup B: Therapeutic exercises + ParacetamolMethods: 4-week intervention with follow-up at 3 and 6 months.Outcome Measures: Pain (VAS), function (WOMAC, COOS), and physical performance (sit-up test, 6-minute walk).Analysis: Data analyzed using SPSS with significance set at p < 0.05. |