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

NCT ID: NCT05693415

Last Updated: 2023-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

154 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-10-15

Brief Summary

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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

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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.

Conditions

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Lumbar Osteoarthritis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Control Group

No treatment

No interventions assigned to this group

Trial Group

Non drug and none surgical treatment of contracted Lumber Spine

Other Names:

Contracture Correction Therapy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Knee Pain Clinic

OTHER

Sponsor Role lead

Responsible Party

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DR R C Agrawal

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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R C Agrawal, MS Surgery

Role: PRINCIPAL_INVESTIGATOR

Knee Pain Clinic

Locations

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Arogya Sadan Nursing Home

Bhind, Madhya Pradesh, India

Site Status

Sai Baba Dharmarth Chikitsalaya

Gwalior, Madhya Pradesh, India

Site Status

Knee Pain Clinic

Gwalior, Madhya Pradesh, India

Site Status

Lok Hitkari Trust Health Camp

Gwalior, Madhya Pradesh, India

Site Status

Parashar Poly Clinic

Gwalior, Madhya Pradesh, India

Site Status

Dr. Shukla Surgery Center

Morena, Madhya Pradesh, India

Site Status

Countries

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India

Other Identifiers

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1002

Identifier Type: -

Identifier Source: org_study_id

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