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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04496440
Other study ID # 1001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 23, 2017
Est. completion date March 30, 2018

Study information

Verified date July 2023
Source Knee Pain Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 138
Est. completion date March 30, 2018
Est. primary completion date December 30, 2017
Accepts healthy volunteers No
Gender All
Age group 30 Years to 80 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Contracture Correction Therapy
Non-drug and non-surgical treatment of contracted knee capsules

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
DR R C Agrawal

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary WOMAC Knee Arthritis score The 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. 6 Months
Secondary EuroQol visual analogue scale (EQ-VAS) A 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. 6 Months
Secondary Deficient Full Flexion (DFF) The 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. 6 Months
Secondary Deficient Full Extension (DFE) The 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. 6 Months
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