| CTRI Number |
CTRI/2020/06/025912 [Registered on: 16/06/2020] Trial Registered Prospectively |
| Last Modified On: |
08/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Application of selected yoga asana on treatment of Osteoarthritis in knee. |
|
Scientific Title of Study
|
Comparison between effects of select yoga asana with exercise therapy in osteoarthritis of knee joint |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akoijam Ravi |
| Designation |
Ph. D Scholar |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Physical Medicine and Rehabilitation
Regional Institute of Medical Sciences, Lamphelpat
Singjamei Makha Oinam Thingel
Imphal Weest - 795008
Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
9612153033 |
| Fax |
|
| Email |
raviakoijam@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Akoijam Ravi |
| Designation |
Ph. D Scholar |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Physical Medicine and Rehabilitation
Regional Institute of Medical Sciences, Lamphelpat
Singjamei Makha Oinam Thingel
Imphal West - 795008
Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
9612153033 |
| Fax |
|
| Email |
raviakoijam@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
N Romi Singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Physical Medicine and Rehabilitation
Regional Institute of Medical Sciences, Lamphelpat
Imphal West
MANIPUR
795004
India |
| Phone |
9436025822 |
| Fax |
|
| Email |
dr.romi.singh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional Institute of Medical Sciences, Imphal West - 795004, Lamphelpat,Manipur |
|
|
Primary Sponsor
|
| Name |
Akoijam Ravi |
| Address |
Department of Physical Medicine and Rehabilitation
Regional Institute of Medical Sciences, Lamphelpat |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| N Romi Singh |
Department of Physical Medicine and Rehabilitation
Regional Institute of Medical Sciences, Lamphelpat |
|
|
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 |
Regional Institute of Medical Sciences |
Department of Physical Medicine and Rehabilitation
Regional Institute of Medical Sciences, Lamphelpat - 795004
Imphal West
MANIPUR |
9612153033
raviakoijam@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board RIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Osteoarthritis of knee joint |
Study of selected Yoga Asanas in osteoarthritis of Knee joint for a period of 2 weeks. |
| Comparator Agent |
placebo control |
Quadriceps and hamstring strengthening exercises + Balance Training in Osteoarthritis of knee joint by giving therapeutic exercises by a trained therapist for a period of 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects in the age group of 45 years to 65 years male and female who fulfilled ACR(acromioclavicular) criteria for the diagnosis of the Osteoarthritis of the knee.
2.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 >30
6.Professional squatters
7.KL grading IV in X-ray
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare select yoga asanas and therapeutic exercises in relieving resting and walking pain, reduction in stiffness of the joint. |
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare select yoga asanas and therapeutic exercises in improving quality of life among subjects with grade I-III osteoarthritis of knee joint. |
9 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
|
N/A |
|
Date of First Enrollment (India)
|
04/07/2020 |
| 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="9"
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)?
|
|
Brief Summary
|
The study is a randomized parallel group, placebo controlled trial to compare the effects of selected yoga asanas with exercise therapy in osteoarthritis of knee joint. The study will be conducted on 70 subjects fulfilling the inclusion and exclusion criteria for 9 months. The primary outcome of the project to compare
select yoga asana like Mountain Pose (Tadasana), Warrior II (Virabhadrasana
II), Bound angle (Baddha Konasana), Staff pose (Dandasana) and therapeutic
exercises like isometric quadriceps and hamstring strengthening exercises with
balance training in relieving resting and walking pain, reduction in stiffness
of the joint. Also the secondary outcome of the project is to assess the improvement in quality of life among subjects
with grade I-III osteoarthritis of knee joint.
|