Primary Osteoarthritis Knee - Establishing Its Cause, Pathogenesis and Treatment
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- DR R C Agrawal
- Enrollment
- 138
- Locations
- 6
- Primary Endpoint
- WOMAC Knee Arthritis score
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
The study was focused on establishing the cause and treatment of a painful knee joint disease (Primary Osteoarthritis Knee = OA Knee). At present the cause and treatment are not known. The study was based on a hypothesis, designing a treatment and testing it through a clinical trial. This established that the deficient full flexion or deficient full extension of knee joints, producing contracture in their capsules was the cause and the correction (Contracture Correction Therapy = CCT) was the cure of the disease. The correction was carried out by passive flexion or passive extension of affected knee through eight body postures designed specifically during the study. To test the efficacy a multi-centre, multi surgeon six months study on 125 patients was carried out, patients were divided into Trial and Control groups. The effects were measured by primary outcome measure - The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score and other measure EuroQol-Visual Analogue Scales (EQ-VAS) score, DFF\*, DFE\^ at 0, 6 ,12 and 24 weeks. The "Intervention" for 1st group was CCT and for the 2nd group was "No intervention". \* Deficient full flexion \^ Deficient full extension
Investigators
DR R C Agrawal
Senior Surgeon
Knee Pain Clinic
Eligibility Criteria
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
- •Leg pain (e.g. sciatica)
- •Inability to lie supine (e.g. kyphosis)
- •Inability to lie prone (e.g. central obesity)
Outcomes
Primary Outcomes
WOMAC Knee Arthritis score
Time Frame: 6 Months
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.
Secondary Outcomes
- EuroQol visual analogue scale (EQ-VAS)(6 Months)
- Deficient Full Extension (DFE)(6 Months)
- Deficient Full Flexion (DFF)(6 Months)