An Attempt to Find Out Root Cause of a Pain Producing Knee Disease

Study Overview
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Brief Summary
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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
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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

Official Title
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Primary Osteoarthritis Knee - Establishing Its Cause, Pathogenesis and Treatment

Conditions
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Knee Osteoarthritis, Arthroplasty, Knee

Intervention / Treatment
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* Other: Contracture Correction Therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trial Group<br>Contracture correction therapy | Other: Contracture Correction Therapy<br>* Non-drug and non-surgical treatment of contracted knee capsules<br>|
| Control Group<br>No new intervention, patients continued with the previous treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deficient full flexion, Deficient full extension, Contracture Correction Therapy