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

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.

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Key information

Conditions

Lumbar Osteoarthritis Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Spine Rheumatic Diseases Spinal Diseases Spondylarthritis Spondylitis

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arogya Sadan Nursing Home, Bhind, Madhya Pradesh, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Time frame: Change from baseline The Western Ontario and McMaster Universities Arthritis Index Osteoarthritis score at 6, 12, 24 weeks

It is a self-administered questionnaire consisting of 24 items divided into 3 subscales

Secondary outcomes

Oswestry Disability Index

Time frame: Change from baseline Oswestry Disability Index score at 6, 12, 24 weeks

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.
EuroQol Visual Analogue Scale score

Time frame: Change from baseline EuroQol Visual Analogue Scale score at 6, 12, 24 weeks

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.

Sponsors and collaborators

Lead sponsor

Knee Pain Clinic

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jan 23, 2023
Registry last updated: Jan 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed