| CTRI Number |
CTRI/2019/02/017422 [Registered on: 04/02/2019] Trial Registered Prospectively |
| Last Modified On: |
28/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
To check the effect of Yoga in Osteoarthritis |
|
Scientific Title of Study
|
Effectiveness of Yoga therapy on Quality Of Life 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 |
Dr Nirav Vaghela |
| Designation |
Associate Professor |
| Affiliation |
KM Patel Institute Of Physiotherapy |
| Address |
K.M.Patel Institute Of Physiotherapy, Room No. 152
Shri Krishna Medical Hospital
Gokulnagar,Karamsad
Anand
K.M.Patel Institute Of Physiotherapy, Room No. 152
Karamsad
Anand
Anand
GUJARAT
388325
India |
| Phone |
9428647304 |
| Fax |
|
| Email |
niravpv@charutarhealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nirav Vaghela |
| Designation |
Associate Professor |
| Affiliation |
KM Patel Institute Of Physiotherapy |
| Address |
K.M.Patel Institute Of Physiotherapy, Room No.152
Shri Krishna Medical Hospital
Gokulnagar,Karamsad
Anand
K.M.Patel Institute Of Physiotherapy, Room No 152
Karamsad
Anand
Anand
GUJARAT
388325
India |
| Phone |
9428647304 |
| Fax |
|
| Email |
niravpv@charutarhealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nirav Vaghela |
| Designation |
Associate Professor |
| Affiliation |
KM Patel Institute Of Physiotherapy |
| Address |
K.M.Patel Institute Of Physiotherapy, Room No 152
Shri Krishna Medical Hospital
Gokulnagar,Karamsad
Anand
K.M.Patel Institute Of Physiotherapy, Room No 152
Karamsad
Anand
Anand
GUJARAT
388325
India |
| Phone |
9428647304 |
| Fax |
|
| Email |
niravpv@charutarhealth.org |
|
|
Source of Monetary or Material Support
|
| Shree krishna Hospital and Vicinity around the Hospital |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| Jayshree Patel |
K.M.Patel Institute of Physiotherapy |
Shree Krishna hospital, Physiotherapy department
Room No. 152
karamsad
Anand
GUJARAT |
7096677301
jpatel2328@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee |
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 |
conventional physiotherapy in group 1 and yoga therapy with conventional physiotherapy in group 2 |
After the baseline evaluation, group 1 (Experimental Group) and group 2 (Control Group) to receive yoga therapy with conventional physiotherapy and conventional physiotherapy respectively.
The experimental group will be given yoga therapy which includes 6 asanas (Tadasana, Uttitha Trikonasana, Virbhadrasana, Dandasana, Sputa Padangustasana, and Baddha Konasana) for 30 min and conventional physiotherapy (Strengthening exercise in form of Static Quadriceps Exercise, Last Degree Knee Extension, Straight Leg Raising, Knee Extension in high sitting and Trans Electrical Nerve Stimulation) for 20 min 3days /week.
The control group will be given conventional physiotherapy (Strengthening exercises in the form of Static Quadriceps Exercise, Last Degree Knee Extension, Straight Leg Raising, Knee Extension in high sitting and Trans Electrical Nerve Stimulation) for 20 min 3 days a week. The intervention to the both groups will be given for 1month. The therapist who is going to conduct treatment sessions will be trained to provide yoga.
First outcome measures will be taken before the session, second outcome measures will be taken after the 15 days, third outcome measures will be taken after 1 month by the Therapist in the form of WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index) scale and SF (Short Form) – 36 Questionnaire.
The scales which are going to be used in our study are not free accessible in gujarati version so we will be using english versions of these scales which are freely accessible.
|
| Comparator Agent |
conventional physiotherapy in group 1 and yoga therapy with conventional physiotherapy in group 2 |
After the baseline evaluation, group 1 (Experimental Group) and group 2 (Control Group) to receive yoga therapy with conventional physiotherapy and conventional physiotherapy respectively.
The experimental group will be given yoga therapy which includes 6 asanas (Tadasana, Uttitha Trikonasana, Virbhadrasana, Dandasana, Sputa Padangustasana, and Baddha Konasana) for 30 min and conventional physiotherapy (Strengthening exercise in form of Static Quadriceps Exercise, Last Degree Knee Extension, Straight Leg Raising, Knee Extension in high sitting and Trans Electrical Nerve Stimulation) for 20 min 3days /week.
The control group will be given conventional physiotherapy (Strengthening exercises in the form of Static Quadriceps Exercise, Last Degree Knee Extension, Straight Leg Raising, Knee Extension in high sitting and Trans Electrical Nerve Stimulation) for 20 min 3 days a week. The intervention to the both groups will be given for 1month. The therapist who is going to conduct treatment sessions will be trained to provide yoga.
First outcome measures will be taken before the session, second outcome measures will be taken after the 15 days, third outcome measures will be taken after 1 month by the Therapist in the form of WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index) scale and SF (Short Form) – 36 Questionnaire.
The scales which are going to be used in our study are not free accessible in gujarati version so we will be using english versions of these scales which are freely accessible. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are diagnosed as having Osteoarthritis of knee according to clinical American College of Rheumatology (ACR) criteria.10 2. Age 40-60 years.
3. Both gender will included.
4. The patients who are functionally ambulative. 5. Have not practiced any form of yoga or exercise in past 2 months. |
|
| ExclusionCriteria |
| Details |
1. Symptoms of locking or instability of knee buckling, shifting or giving way of the in past 3 months
2. A corticosteroid injection within 2 months
3. Patients with Total knee arthroplasty (TKA)
4. Severe knee pain (i.e., Visual Analogue Scale (VAS) >8)
5. Inflammatory arthritis
6. Any recent trauma of knee joint or lower limb 7. Patients who are taking analgesics |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
WOMAC scale- “The Western Ontario and McMasters Universities Osteoarthritis Index"
at baseline, after 15 days and after 30 days
|
WOMAC scale- “The Western Ontario and McMasters Universities Osteoarthritis Index"
at base line,after 15 days and after 30 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Short Form 36 questioner at baseline, after 15 days and after 30 days. |
Short Form 36 questioner at baseline, after 15 days and after 30 days. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 1 |
|
Date of First Enrollment (India)
|
15/02/2019 |
| 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="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Osteoarthritis (OA) is a chronic degenerative disorder which priminary affecting the articular cartilage of synovial joints, then boney remodeling and overgrowth at the margins of the joints occurs.
The consequences of Osteoarthritis is Pain, joint stiffness, decreased muscle performance, and decreased aerobic capacity which affect the quality of life and increase the risk for disability for the individual with Osteoarthritis.
Osteoarthritis (OA) is the second most common rheumatologic problem in India and has a prevalence rate of 22–39%. Worldwide prevalence rate of Osteoarthritis is 20% for men, 41% for women. Osteoarthritis causes pain or dysfunction in 20% of the elder people. Relieving pain stiffness and improving physical functions are the important goals of the present day therapy.
OA is a chronic condition that has no effective cure, so self-management is important to control the symptoms of Osteoarthritis3. Recent practice guidelines recognize that exercise is a key element of any treatment program for Osteoarthritis. It is recommended that moderate physical activity at least three times per week can reduce the risk of arthritis-related disability by 47 %.
The prolonged disability and pain will lead to loss of quadriceps femoris muscle strength (loss of force-generating capacity of muscle), coronary heart disease, and depression. The treatment of osteoarthritis included Nonsteroidal anti-inflammatory drugs (NSAIDs), physical therapy exercise and treatment programs, cortisone injections, and joint replacement surgery.
The physiotherapist plays an important role in the patients with hip and knee osteoarthritis5.Fitness walking, aerobic exercise, and strength training have all been reported to result in functional improvement in patients with osteoarthritis of the knee.
|