Knee OsteoarthritisNCT04496440
An Attempt to Find Out Root Cause of a Pain Producing Knee Disease
An observational study of Knee Osteoarthritis and Arthroplasty, run by DR R C Agrawal at 6 sites in India.
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Arthroplasty, Knee
- What is being tested?
- Contracture Correction Therapy
- Type of treatment
- Pill or oral medicine
- How many people
- 138 participants
- Where
- 6 sitesIndia
- Study dates
- 23 Mar 2017to 30 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Gwalior a city in India and multiple surrounding towns
Who may be able to join
- 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
Who cannot join
- Backache
- Leg pain (e.g. sciatica)
- Inability to lie supine (e.g. kyphosis)
- Inability to lie prone (e.g. central obesity)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
India6 sites
Arogya Sadan Nursing Home
Bhind, Madhya Pradesh, 477001
Sai Baba Dharmarth Chikitsalaya
Gwalior, Madhya Pradesh, 474003
Parashar Poly Clinic
Gwalior, Madhya Pradesh, 474010
Knee Pain Clinic
Gwalior, Madhya Pradesh, 474012
Lok Hitkari Trust Health Camp
Gwalior, Madhya Pradesh, 474012
Dr. Shukla Surgery Center
Morena, Madhya Pradesh, 476001
About this study
Official title: 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.
Read the 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
- Conditions
- Knee Osteoarthritis, Arthroplasty, Knee
- Being tested
- Contracture Correction Therapy
- Keywords
- Deficient full flexion, Deficient full extension, Contracture Correction Therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contracture Correction TherapyOther
Non-drug and non-surgical treatment of contracted knee capsules
| Study group | Role | What they receive |
|---|---|---|
| Trial Group | Contracture correction therapy Receives: Other: Contracture Correction Therapy | |
| Control Group | No new intervention, patients continued with the previous treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start23 Mar 2017
- Primary completion30 Dec 2017
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- DR R C Agrawal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, DR R C Agrawal, Knee Pain Clinic
- Investigators
- R C Agrawal, MBBS,MS,FICS, Principal investigator, Knee Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496440
- Sponsor's protocol ID
- 1001
- Status last verified
- Jul 2023
- First submitted
- 28 Jun 2020
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Osteoarthritis Knee - Establishing Its Cause, Pathogenesis and Treatment
- ClinicalTrials.gov ID
- NCT04496440
- Acronym / sponsor ID
- 1001
- Conditions
- Knee Osteoarthritis, Arthroplasty, Knee
- Keywords
- Deficient full flexion, Deficient full extension, Contracture Correction Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- DR R C AgrawalUniversity, hospital or other
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 3 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial Group | – | Other: Contracture Correction TherapyContracture correction therapy |
| Control Group | – | –No new intervention, patients continued with the previous treatment. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gwalior a city in India and multiple surrounding towns
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Backache
- Leg pain (e.g. sciatica)
- Inability to lie supine (e.g. kyphosis)
- Inability to lie prone (e.g. central obesity)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contracture Correction TherapyNon-drug and non-surgical treatment of contracted knee capsules | Other | Trial Group |
Primary outcome
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.
3 secondary outcomes
EuroQol visual analogue scale (EQ-VAS)
Time frame: 6 Months
Deficient Full Flexion (DFF)
Time frame: 6 Months
Deficient Full Extension (DFE)
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- 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.Link provided by the sponsor.
- EuroQol-visual analogue scales - It measure the health status on 20 cms. vertical scale, 0-100, 100 represent best health.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R C Agrawal, MBBS,MS,FICS principal investigator
Knee Pain Clinic
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Arthroplasty, run by DR R C Agrawal at 6 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC Knee Arthritis score (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.