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The study was about a root cause of Primary Osteoarthritis Lumbar Spine producing disabilities in sitting, climbing 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 154 patients (100 in the trial group, 50 in the control group) for a duration of six months.
The study was focused on establishing the cause, pathogenesis and treatment of painful Lumbar Spine disease (Primary Osteoarthritis Lumbar Spine = OA Lumbar Spine) at present the exact cause and treatment are not known. It was aimed to find out to latter through a hypothesis by designing a treatment and testing it with a clinical trial.
This established that the deficient full extension of the spinal joints (intervertebral joints between the adjacent vertebrae from T12 to S1) producing contracture in their capsules in front, was the cause and the correction (Contracture Correction Therapy = CCT) was the cure of the disease. The correction was carried out by intermittent and sustained extension of the lumbar spin through three designed body postures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No treatment | ||
| Trial Group | Non drug and none surgical treatment of contracted Lumber Spine Other Names: Contracture Correction Therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| The Western Ontario and McMaster Universities Arthritis Index (WOMAC) | It is a self-administered questionnaire consisting of 24 items divided into 3 subscales | Change from baseline The Western Ontario and McMaster Universities Arthritis Index Osteoarthritis score at 6, 12, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index | Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. | Change from baseline Oswestry Disability Index score at 6, 12, 24 weeks |
| EuroQol Visual Analogue Scale score |
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Inclusion Criteria:
Exclusion Criteria:
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Group includes people across locations in and Gwalior city. Trial was based on "Pragmatic Cluster Randomized Controlled Trial", also known as Cluster Randomized Trial (CRT) or Group Randomized Trial. In this variety pre-existing groups, called clusters, of individuals are randomly allocated to treatment arms. The subjects, who consulted me, were of two types. The type I wanted to avoid surgery, had tried other nonsurgical options and did not want those anymore. These patients were included in trial group and took my designed treatment (Contracture Correction Therapy = CCT). The other type of patients who did not consent for the new treatment were included in the control group.
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| Name | Affiliation | Role |
|---|---|---|
| R C Agrawal, MS Surgery | 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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| ID | Term |
|---|---|
| D055013 | Osteoarthritis, Spine |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
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The EQ-VAS is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health. |
| Change from baseline EuroQol Visual Analogue Scale score at 6, 12, 24 weeks |
| Gwalior |
| Madhya Pradesh |
| 474003 |
| India |
| Knee Pain Clinic | Gwalior | Madhya Pradesh | 474012 | India |
| Lok Hitkari Trust Health Camp | Gwalior | Madhya Pradesh | 474012 | India |
| Parashar Poly Clinic | Gwalior | Madhya Pradesh | 474012 | India |
| Dr. Shukla Surgery Center | Morena | Madhya Pradesh | 476001 | India |
| D009140 |
| Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D012216 | Rheumatic Diseases |