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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05693415

Enrollment

154

Registered

2023-01-23

Start date

2021-07-01

Completion date

2022-10-15

Last updated

2023-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Osteoarthritis

Keywords

Osteoarthritis, Lumbar Spine, Intervertebral Joint, Capsule Contracture, Discectomy, Ideopathic

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)	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

Measure	Time frame	Description
Oswestry Disability Index	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	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.

Countries

India

Outcome results