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NCT Number: NCT04496440

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

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.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arogya Sadan Nursing Home, Bhind, Madhya Pradesh, India

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Contracture Correction Therapy

Other

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

Primary outcomes

  1. WOMAC Knee Arthritis score

    Time frame: 6 Months

    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.

Secondary outcomes

  1. EuroQol visual analogue scale (EQ-VAS)

    Time frame: 6 Months

    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.

  2. Deficient Full Flexion (DFF)

    Time frame: 6 Months

    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.

  3. Deficient Full Extension (DFE)

    Time frame: 6 Months

    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.

Sponsors and collaborators

Lead sponsor

DR R C Agrawal

Other

Registry information

Official study title

Primary Osteoarthritis Knee - Establishing Its Cause, Pathogenesis and Treatment

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Aug 3, 2020
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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