Osteoarthritis, Knee Clinical Trial
— Team-KPOfficial title:
The East-Midlands Knee Pain Multiple Randomised Controlled Trial Cohort Study: Cohort Establishment and Feasibility Cohort-randomised Controlled Trial
NCT number | NCT03670706 |
Other study ID # | Team-KP |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 26, 2018 |
Est. completion date | July 5, 2021 |
Verified date | September 2021 |
Source | University of Nottingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
1. To develop a training package for nurse-led management of knee osteoarthritis (OA), incorporating information about OA and core non-pharmacologic and pharmacologic principles of management of OA as recommended in the National Institute for Clinical Excellence and Health (NICE) guidelines for management of OA 2. To evaluate fidelity of delivery of individual components of this complex package of care for knee pain 3. To assess the acceptability of the intervention by exploring participant satisfaction with nurse-led complex package of care of knee pain. 4. To explore and resolve possible challenges to delivery of individual components within a complex package 5. To examine the feasibility of a definitive cohort randomised controlled trial of nurse-led care versus usual care of knee pain in terms of recruitment rate, drop-out rate, reasons for dropping out and completeness of outcome data 6. To explore whether such a trial should provide analgesia before non-pharmacologic interventions or vice versa
Status | Completed |
Enrollment | 1806 |
Est. completion date | July 5, 2021 |
Est. primary completion date | July 5, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: - Knee pain on most days of the previous month - At least moderate pain on two of the five WOMAC knee pain domains in the most painful knee - Knee pain present for longer than 3 months Exclusion Criteria:• House-bound or care home resident - Dementia - Dialysis - On home oxygen - Serious mental illness - Inability to communicate in English - Unable to give consent - Terminal cancer - Known diagnosis of autoimmune rheumatic diseases or psoriasis - Knee or hip replacement, or on waiting list for knee or hip replacement - Asthma or COPD requiring regular daily oral corticosteroids - Unstable angina or heart failure - Known peripheral vascular disease - Pregnant |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Nottingham University Hospitals NHS Trust | Nottingham |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | questionnairehe Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:
Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties |
26 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03895489 -
Effectiveness of the Journey Total Knee Arthroplasty Versus Two Standard of Care Total Knee Arthroplasty Prostheses
|
N/A | |
Completed |
NCT03660943 -
A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain
|
Phase 3 | |
Completed |
NCT04531969 -
Comparison of Outpatient and Inpatient Spa Therapy
|
N/A | |
Completed |
NCT02848027 -
Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment
|
Phase 3 | |
Completed |
NCT05160246 -
The Instant Effect of Kinesiology Taping in Patients With Knee OA
|
N/A | |
Recruiting |
NCT06080763 -
Biomechanics and Clinical Outcomes in Responders and Non-Responders
|
||
Completed |
NCT03643588 -
The Comparison of HYAJOINT Plus and Hyalgan Hyaluronan Supplement for Knee Osteoarthritis Pain
|
N/A | |
Active, not recruiting |
NCT05100225 -
Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis
|
Phase 2 | |
Active, not recruiting |
NCT04061733 -
New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis
|
N/A | |
Completed |
NCT04051489 -
A Novel Smartphone Application for "Smart" Knee Osteoarthritis Trials
|
||
Recruiting |
NCT05546541 -
Epidemiology and Nutrition
|
||
Recruiting |
NCT05447767 -
Prediction AlgoriThm for regeneraTive Medicine Approach in knEe OA: New Decision-making Process Based on Patient pRofiliNg
|
Phase 2 | |
Not yet recruiting |
NCT04448106 -
Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis
|
Phase 2 | |
Not yet recruiting |
NCT03225911 -
Effect of a Lateral Wedge Insole and Simple Knee Sleeve in Individuals With Knee Osteoarthritis
|
N/A | |
Completed |
NCT05070871 -
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
|
N/A | |
Completed |
NCT05703087 -
Positive Cueing in Knee Arthroplasty.
|
N/A | |
Not yet recruiting |
NCT06042426 -
Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population
|
Phase 4 | |
Completed |
NCT02881775 -
Immediate Effects of rTMS on Excitability of the Quadriceps With Knee Osteoarthritis
|
N/A | |
Completed |
NCT02901964 -
Effect of Strengthening the Hip Abductor in Patients With Knee Osteoarthritis: Randomized Controlled Trial
|
N/A | |
Not yet recruiting |
NCT02854176 -
Somatosensory Stimulation in Knee Osteoarthritis
|
Phase 2 |