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.

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Osteoarthritis

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 Type: Observational
• Enrollment (Actual): 154

Contacts and Locations

Study Locations

• India
  • Madhya Pradesh
    • Bhind, Madhya Pradesh, India, 477001
      • Arogya Sadan Nursing Home
    • Gwalior, Madhya Pradesh, India, 474003
      • Sai Baba Dharmarth Chikitsalaya
    • Gwalior, Madhya Pradesh, India, 474012
      • Knee Pain Clinic
    • Gwalior, Madhya Pradesh, India, 474012
      • Lok Hitkari Trust Health Camp
    • Gwalior, Madhya Pradesh, India, 474012
      • Parashar Poly Clinic
    • Morena, Madhya Pradesh, India, 476001
      • Dr. Shukla Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control Group; No treatment
Trial Group; Non drug and none surgical treatment of contracted Lumber Spine Other Names: Contracture Correction Therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Knee Pain Clinic
• Investigators: Principal Investigator: R C Agrawal, MS Surgery, Knee Pain Clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): October 15, 2022

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Osteoarthritis; Lumbar Spine; Discectomy; Intervertebral Joint; Capsule Contracture; Ideopathic
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthritis; Spondylitis; Osteoarthritis; Osteoarthritis, Spine
• Other Study ID Numbers: 1002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No