Clinical trial NCT04496440: An Attempt to Find Out Root Cause of a Pain Producing Knee Disease
Official title: Primary Osteoarthritis Knee - Establishing Its Cause, Pathogenesis and Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Arthroplasty
Knee
Keywords: Deficient full flexion
Deficient full extension
Contracture Correction Therapy
Lead sponsor: Knee Pain Clinic
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 138
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gwalior a city in India and multiple surrounding towns

Brief summary: This study was focused on a type of arthritis (knee) in which patients develop pain with disabilities in sitting 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 125 patients (100 in the trial group, 25 in the control group) for a duration of six months.

Detailed description: The study was focused on establishing the cause and treatment of a painful knee joint disease (Primary Osteoarthritis Knee = OA Knee). At present the cause and treatment are not known. The study was based on a hypothesis, designing a treatment and testing it through a clinical trial. This established that the deficient full flexion or deficient full extension of knee joints, producing contracture in their capsules was the cause and the correction (Contracture Correction Therapy = CCT) was the cure of the disease. The correction was carried out by passive flexion or passive extension of affected knee through eight body postures designed specifically during the study.

To test the efficacy a multi-centre, multi surgeon six months study on 125 patients was carried out, patients were divided into Trial and Control groups. The effects were measured by primary outcome measure - The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score and other measure EuroQol-Visual Analogue Scales (EQ-VAS) score, DFF\*, DFE\^ at 0, 6 ,12 and 24 weeks.

The "Intervention" for 1st group was CCT and for the 2nd group was "No intervention".

\* Deficient full flexion

\^ Deficient full extension

Eligibility criteria: Inclusion Criteria:

* Age =\>30 years
* Knee pain which appeared without any apparent cause, exacerbated by exertion and subsided 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:

* Backache
* Leg pain (e.g. sciatica)
* Inability to lie supine (e.g. kyphosis)
* Inability to lie prone (e.g. central obesity)

Primary outcomes:
measure: WOMAC Knee Arthritis score
timeFrame: 6 Months
Secondary outcomes:
measure: EuroQol visual analogue scale (EQ-VAS)
timeFrame: 6 Months
measure: Deficient Full Flexion (DFF)
timeFrame: 6 Months
measure: Deficient Full Extension (DFE)
timeFrame: 6 Months
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: Parashar Poly Clinic
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: Morena
country: India
facility: Dr. Shukla Surgery Center
state: Madhya Pradesh
Study officials:
affiliation: Knee Pain Clinic
name: R C Agrawal, MBBS,MS,FICS
role: PRINCIPAL_INVESTIGATOR
References: