Clinical trial NCT05693415: Primary Osteoarthritis Lumbar Spine: Establishing Its Cause, Pathogenesis and Treatment.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Osteoarthritis
Keywords: Osteoarthritis
Lumbar Spine
Intervertebral Joint
Capsule Contracture
Discectomy
Ideopathic
Lead sponsor: Knee Pain Clinic
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 154
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: Change from baseline The Western Ontario and McMaster Universities Arthritis Index Osteoarthritis score at 6, 12, 24 weeks
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: Change from baseline Oswestry Disability Index score at 6, 12, 24 weeks
measure: EuroQol Visual Analogue Scale score
timeFrame: Change from baseline EuroQol Visual Analogue Scale score at 6, 12, 24 weeks
Other outcomes:
Locations:
city: Bhind
country: India
facility: Arogya Sadan Nursing Home
state: Madhya Pradesh
city: Gwalior
country: India
facility: Sai Baba Dharmarth Chikitsalaya
state: Madhya Pradesh
city: Gwalior
country: India
facility: Knee Pain Clinic
state: Madhya Pradesh
city: Gwalior
country: India
facility: Lok Hitkari Trust Health Camp
state: Madhya Pradesh
city: Gwalior
country: India
facility: Parashar Poly Clinic
state: Madhya Pradesh
city: Morena
country: India
facility: Dr. Shukla Surgery Center
state: Madhya Pradesh
Study officials:
affiliation: Knee Pain Clinic
name: R C Agrawal, MS Surgery
role: PRINCIPAL_INVESTIGATOR
References: