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

Completed

• Conditions: Lumbar Osteoarthritis

• Registration Number: NCT05693415
• Lead Sponsor: Knee Pain Clinic

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.

Study Timeline

• Study Start: 2021-07-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-10-15
• Study First Submitted: 2022-10-26
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-11
• Last Update Submitted: 2023-01-11
• Study First Posted: 2023-01-23
• Last Update Posted: 2023-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (6)

Lok Hitkari Trust Health Camp; 🇮🇳 Gwalior, Madhya Pradesh, India

Dr. Shukla Surgery Center; 🇮🇳 Morena, Madhya Pradesh, India

Arogya Sadan Nursing Home; 🇮🇳 Bhind, Madhya Pradesh, India

Sai Baba Dharmarth Chikitsalaya; 🇮🇳 Gwalior, Madhya Pradesh, India

Knee Pain Clinic; 🇮🇳 Gwalior, Madhya Pradesh, India

Parashar Poly Clinic; 🇮🇳 Gwalior, Madhya Pradesh, India