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An Attempt to Find Out Root Cause of a Pain Producing Knee Disease

Primary Osteoarthritis Knee - Establishing Its Cause, Pathogenesis and Treatment

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04496440
Enrollment
138
Registered
2020-08-03
Start date
2017-03-23
Completion date
2018-03-30
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Knee, Knee Osteoarthritis

Keywords

Deficient full flexion, Deficient full extension, Contracture Correction Therapy

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

Interventions

OTHERContracture Correction Therapy

Non-drug and non-surgical treatment of contracted knee capsules

Sponsors

DR R C Agrawal
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
WOMAC Knee Arthritis score6 MonthsThe Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) on a five point likert-type scale. Range 0-96, 0=BEST and 96=WORST. To access a change from baseline score at six months.

Secondary

MeasureTime frameDescription
EuroQol visual analogue scale (EQ-VAS)6 MonthsA 20 centimetre vertical visual analogue scale (EQ-VAS), that takes values between 100 (best imaginable health) and 0 (worst imaginable health). To access a change from baseline score at six months.
Deficient Full Flexion (DFF)6 MonthsThe degree by which flexion is lesser then 145°. Full flexion is measured by Goniometer, expressed in blocks of 5°, such as 140°, 135°, 130° etc. In first case DFF is 145-140 = 5°. Higher degree of DFF denotes higher severity. To access a change from baseline score at six months.
Deficient Full Extension (DFE)6 MonthsThe degree by which full extension falls short to 0°. When full Range of Motion (ROM) is 0-145° and full extension is 145° the Full extension is should be 0.The DFE are represented by 5°, 10°, 15° etc. Higher degree of DFE denotes higher severity. To access a change from baseline score at six months.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026