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

Primary Osteoarthritis Knee - Establishing Its Cause, Pathogenesis and Treatment

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Arthroplasty; Knee
• Intervention / Treatment: Other: Contracture Correction Therapy

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

• Study Type: Observational
• Enrollment (Actual): 138

Contacts and Locations

Study Locations

• India
  • Madhya Pradesh
    • Bhind, Madhya Pradesh, India, 477001
      • Arogya Sadan Nursing Home
    • Gwalior, Madhya Pradesh, India, 474003
      • Sai Baba Dharmarth Chikitsalaya
    • Gwalior, Madhya Pradesh, India, 474012
      • Knee Pain Clinic
    • Gwalior, Madhya Pradesh, India, 474012
      • Lok Hitkari Trust Health Camp
    • Gwalior, Madhya Pradesh, India, 474010
      • Parashar Poly Clinic
    • Morena, Madhya Pradesh, India, 476001
      • Dr. Shukla Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Gwalior a city in India and multiple surrounding towns

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Trial Group; Contracture correction therapy	Other: Contracture Correction Therapy; Non-drug and non-surgical treatment of contracted knee capsules
Control Group; No new intervention, patients continued with the previous treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: DR R C Agrawal
• Investigators: Principal Investigator: R C Agrawal, MBBS,MS,FICS, Knee Pain Clinic

Publications and helpful links

Helpful Links

• The WOMAC is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee.
• EuroQol-visual analogue scales - It measure the health status on 20 cms. vertical scale, 0-100, 100 represent best health.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2017
• Primary Completion (Actual): December 30, 2017
• Study Completion (Actual): March 30, 2018

Study Registration Dates

• First Submitted: June 28, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 23, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Deficient full flexion; Deficient full extension; Contracture Correction Therapy
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 1001 (Registro Nacional Estudios Clinicos (RNEC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No