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

Lumbar Osteoarthritis Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05693415
• Other study ID #: 1002
• Status: Completed
• Start date: July 1, 2021
• Est. completion date: October 15, 2022

Study information

• Verified date: January 2023
• Source: Knee Pain Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: October 15, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Spine

Locations

Country	Name	City	State
India	Arogya Sadan Nursing Home	Bhind	Madhya Pradesh
India	Knee Pain Clinic	Gwalior	Madhya Pradesh
India	Lok Hitkari Trust Health Camp	Gwalior	Madhya Pradesh
India	Parashar Poly Clinic	Gwalior	Madhya Pradesh
India	Sai Baba Dharmarth Chikitsalaya	Gwalior	Madhya Pradesh
India	Dr. Shukla Surgery Center	Morena	Madhya Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Knee Pain Clinic

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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