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

NCT05693415 | Completed

• 1 other identifier: 1002
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 6

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.

Conditions

Lumbar Osteoarthritis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Oswestry Disability Index

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

• EuroQol Visual Analogue Scale score

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

Study Arms (2)

Control Group

No treatment

Trial Group

Non drug and none surgical treatment of contracted Lumber Spine Other Names: Contracture Correction Therapy

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Neckache
• Frozen shoulder
• Central obesity
• Acute Lumbago
• X-ray spine with no OA signs

Sponsors & Collaborators

• Knee Pain Clinic: lead

Study Sites (6)

Arogya Sadan Nursing Home

Bhind, Madhya Pradesh, 477001, India

Location

Sai Baba Dharmarth Chikitsalaya

Gwalior, Madhya Pradesh, 474003, India

Location

Knee Pain Clinic

Gwalior, Madhya Pradesh, 474012, India

Location

Lok Hitkari Trust Health Camp

Gwalior, Madhya Pradesh, 474012, India

Location

Parashar Poly Clinic

Gwalior, Madhya Pradesh, 474012, India

Location

Dr. Shukla Surgery Center

Morena, Madhya Pradesh, 476001, India

Location

MeSH Terms

Conditions

Osteoarthritis, Spine; Osteoarthritis

Condition Hierarchy (Ancestors)

Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases

Study Officials

• R C Agrawal, MS Surgery

  Knee Pain Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: January 23, 2023
• Study Start: July 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: October 15, 2022
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (6)