Knee Osteoarthritis Clinical Trial
Official title:
Primary Osteoarthritis Knee - Establishing Its Cause, Pathogenesis and Treatment
NCT number | NCT04496440 |
Other study ID # | 1001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 23, 2017 |
Est. completion date | March 30, 2018 |
Verified date | July 2023 |
Source | Knee Pain Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study was focused on a type of arthritis (knee) in which patients develop pain with disabilities in sitting and walking etc. In advance stage the person is bereft of his/her personal physical activities. The prevalent treatment is temporary and dis-satisfactory. A new treatment was designed and a trial was conducted on 125 patients (100 in the trial group, 25 in the control group) for a duration of six months.
Status | Completed |
Enrollment | 138 |
Est. completion date | March 30, 2018 |
Est. primary completion date | December 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 80 Years |
Eligibility | Inclusion Criteria: - Age =>30 years - Knee pain which appeared without any apparent cause, exacerbated by exertion and subsided by rest. - Presence of limited morning stiffness - No history of infection, inflammation or trauma to rule out secondary OA - Disability in sitting, climbing stairs or walking Exclusion Criteria: - Backache - Leg pain (e.g. sciatica) - Inability to lie supine (e.g. kyphosis) - Inability to lie prone (e.g. central obesity) |
Country | Name | City | State |
---|---|---|---|
India | Arogya Sadan Nursing Home | Bhind | Madhya Pradesh |
India | Knee Pain Clinic | Gwalior | Madhya Pradesh |
India | Lok Hitkari Trust Health Camp | Gwalior | Madhya Pradesh |
India | Parashar Poly Clinic | Gwalior | Madhya Pradesh |
India | Sai Baba Dharmarth Chikitsalaya | Gwalior | Madhya Pradesh |
India | Dr. Shukla Surgery Center | Morena | Madhya Pradesh |
Lead Sponsor | Collaborator |
---|---|
DR R C Agrawal |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | WOMAC Knee Arthritis score | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) on a five point likert-type scale. Range 0-96, 0=BEST and 96=WORST. To access a change from baseline score at six months. | 6 Months | |
Secondary | EuroQol visual analogue scale (EQ-VAS) | A 20 centimetre vertical visual analogue scale (EQ-VAS), that takes values between 100 (best imaginable health) and 0 (worst imaginable health). To access a change from baseline score at six months. | 6 Months | |
Secondary | Deficient Full Flexion (DFF) | The degree by which flexion is lesser then 145°. Full flexion is measured by Goniometer, expressed in blocks of 5°, such as 140°, 135°, 130° etc. In first case DFF is 145-140 = 5°. Higher degree of DFF denotes higher severity. To access a change from baseline score at six months. | 6 Months | |
Secondary | Deficient Full Extension (DFE) | The degree by which full extension falls short to 0°. When full Range of Motion (ROM) is 0-145° and full extension is 145° the Full extension is should be 0.The DFE are represented by 5°, 10°, 15° etc. Higher degree of DFE denotes higher severity. To access a change from baseline score at six months. | 6 Months |
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