NCT06576557 Knowledge Translation and Exercise for Degenerative Meniscal Tears and Early Osteoarthritis: KNEE-DEeP Study
| NCT ID | NCT06576557 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Limerick |
| Condition | Osteoarthritis, Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2024-06-01 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Knee pain due to a degenerative meniscal tear (DMT) or early osteoarthritis (OA) is a frequent presentation in middle-aged and older adults. In the knee joint a DMT can occur normally with age, but is also associated with the continuum of knee OA. Exercise is recommended as the main treatment to aid recovery, while an arthroscopy (camera in the knee) to remove torn cartilage does not provide any additional benefit. Despite this many patients in Ireland with this type of knee pain are referred to an orthopaedic surgeon by their GP, and do not receive recommended care from their physiotherapist. The first phase of this project designed the KNEE-DEeP (Knowledge Translation and Exercise for Early Degenerative Knee Pain) intervention to deliver better care to patients with DMT and early OA. The overall aim of this feasibility study is to test the KNEE-DEeP intervention to ensure it can be delivered as planned and it is acceptable to patients, and health care professionals (HCPs) involved in intervention delivery; GPs and physiotherapists. This is in preparation for carrying out a larger future trial. As part of the intervention, GPs and physiotherapists will receive an educational workshop. Patient participants in turn will receive an 'enhanced consultation' from their participating GP and a 'best practice' physiotherapy session focusing on strategies to enhance self-management. This approach will be tested out by enrolling 15 GPs, five physiotherapist and 36 patients in the feasibility study. Patients will be followed up after 12 weeks and six months to track their progress. As part of the evaluation all GPs, physiotherapists and patients will complete questionnaires and a sub-set will provide more in-depth feedback via interviews conducted over the phone or online.
Eligibility Criteria
Inclusion Criteria for Participants with Knee Pain: * Attended their GP with an episode of non-traumatic knee pain * Have knee pain attributed to a DMT or early degenerative changes based on the GP's clinical assessment (this standardised assessment is a component of the GP training) * Aged between 35 and 69 years inclusive Exclusion Criteria: * Recent trauma likely to be associated with considerable tissue damage * Fulfilling the American College of Rheumatology clinical classification criteria for knee OA (these criteria reflect later signs of OA or established disease) * Moderate or advanced knee OA on x-ray (or Kellgren-Lawrence x-ray score ≥ Grade 3) * Having an acutely swollen or locked knee, or suspected ligament injury on physical exam * Inflammatory arthritis * Surgery or significant trauma of the index knee within the previous 2 years * Pregnancy * Unable to communicate in English * Preference for accessing physiotherapy treatment privately prior to the 'best practice' session. Inclusion Criteria for Participating GPs (n=15) and Physiotherapists (n=5): * Eligible GPs will be working in practices within traveling distance (\< 50 km) of University Hospital Kerry and willing to attend a two-hour training workshop * Eligible physiotherapists will be involved in the delivery of outpatient musculoskeletal physiotherapy services at University Hospital Kerry and available to participate in training to deliver the 'best practice' physiotherapy intervention
Contact & Investigator
Helen O'Leary, BSc Physio
PRINCIPAL INVESTIGATOR
University of Limerick
Frequently Asked Questions
Who can join the NCT06576557 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 69 Years, studying Osteoarthritis, Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06576557 currently recruiting?
Yes, NCT06576557 is actively recruiting participants. Contact the research team at liamg.ryan@hse.ie for enrollment information.
Where is the NCT06576557 trial being conducted?
This trial is being conducted at Tralee, Ireland.
Who is sponsoring the NCT06576557 clinical trial?
NCT06576557 is sponsored by University of Limerick. The principal investigator is Helen O'Leary, BSc Physio at University of Limerick. The trial plans to enroll 36 participants.