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

Knee Osteoarthritis Clinical Trial

Official title:

Primary Osteoarthritis Knee - Establishing Its Cause, Pathogenesis and Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04496440
• Other study ID #: 1001
• Status: Completed
• 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
• 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)

Related Conditions & MeSH terms

• Arthroplasty
• Knee
• Knee Osteoarthritis
• Osteoarthritis

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

External Links

•   EuroQol-visual analogue scales - It measure the health status on 20 cms. vertical scale, 0-100, 100 represent best health.
•   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.