Primary Osteoarthritis Lumbar Spine: Establishing Its Cause, Pathogenesis and Treatment.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Primary Osteoarthritis Lumbar Spine Presenting as Chronic Low Back Pain or Sciatica or Both (Prolapsed Lumbar Disc Syndrome): Establishing Its Cause, Pathogenesis and Treatment.

Conditions
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Lumbar Osteoarthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age =>30 and <=90 years Back/leg pain or both combined, which appears without any apparent cause, exacerbated by exertion and subsides 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: Neckache Frozen shoulder Central obesity Acute Lumbago X-ray spine with no OA signs

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 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 |
| --- | --- |
| Control Group<br>No treatment | |
| Trial Group<br>Non drug and none surgical treatment of contracted Lumber Spine Other Names: Contracture Correction Therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Lumbar Spine, Intervertebral Joint, Capsule Contracture, Discectomy, Ideopathic