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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial Group | Contracture correction therapy |
| |
| Control Group | No new intervention, patients continued with the previous treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contracture Correction Therapy | Other | Non-drug and non-surgical treatment of contracted knee capsules |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Gwalior a city in India and multiple surrounding towns
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| Name | Affiliation | Role |
|---|---|---|
| R C Agrawal, MBBS,MS,FICS | Knee Pain Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arogya Sadan Nursing Home | Bhind | Madhya Pradesh | 477001 | India | ||
| Sai Baba Dharmarth Chikitsalaya |
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| Label | URL |
|---|---|
| The WOMAC is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee. | View source |
| EuroQol-visual analogue scales - It measure the health status on 20 cms. vertical scale, 0-100, 100 represent best health. | View source |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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 |
| Gwalior |
| Madhya Pradesh |
| 474003 |
| India |
| Parashar Poly Clinic | Gwalior | Madhya Pradesh | 474010 | India |
| Knee Pain Clinic | Gwalior | Madhya Pradesh | 474012 | India |
| Lok Hitkari Trust Health Camp | Gwalior | Madhya Pradesh | 474012 | India |
| Dr. Shukla Surgery Center | Morena | Madhya Pradesh | 476001 | India |
| D012216 |
| Rheumatic Diseases |