Knowledge Translation and Exercise for Degenerative Meniscal Tears and Early Osteoarthritis: KNEE-DEeP Study
- Conditions
- Osteoarthritis, KneeMeniscus; Degeneration
- Interventions
- Other: KNEE-DEeP intervention- Knowledge translation and exercise for early degenerative knee pain
- Registration Number
- NCT06576557
- Lead Sponsor
- University of Limerick
- 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.
- Detailed Description
KNEE-DEeP Intervention Design
The KNEE-DEeP intervention was designed to address modifiable barriers at the patient, provider and system level to evidence based care for DMT and early OA. According to the Medical Research Council's guidance on the development and evaluation of complex healthcare interventions a multi-component strategy is needed to address these barriers, using the best available evidence and appropriate theory.
The intervention was designed using the Behavioural Change Wheel (BCW) eight-step process. The Theoretical Domains Framework (TDF) was used to identify relevant determinants of change and develop an in-depth understanding of each target behaviour. The KNEE-DEeP intervention will target both GPs and physiotherapists, and their patients with early OA and DMT. GPs will receive a training workshop and educational resources to facilitate an enhanced clinical consultation about this type of knee pain. Given the emphasis placed by Irish GPs on timely access to physiotherapy in managing this condition, early access to a single 'best practice' session of physiotherapy will be a key component of the patient intervention to address this service-level barrier. The content of the patient intervention delivered by the GP and physiotherapist will be underpinned by clinical practice guidelines, stakeholder input and the evidence base on management of chronic knee pain.
Specific KNEE-DEeP study objectives are:
1. Determine the acceptability of the intervention content and delivery to HCPs and patients
2. Determine adherence of GPs and physiotherapists to study processes around intervention delivery to patients
3. Assess fidelity related to intervention delivery and intervention receipt, from the perspectives of HCPs and patients.
4. Determine if data collection procedures and outcome measures are feasible and acceptable to HCPs and patients
5. Determine feasibility of HCP and patients' recruitment and retention procedures
6. Investigate the magnitude of change and variability in the clinical outcome measures
Study Design and Setting
The KNEE-DEeP study is a non-randomised feasibility study that includes an embedded mixed methods process evaluation. Assessments will be performed at baseline, 12 weeks (primary endpoint) and 24 weeks. Recruitment is anticipated to last 6 months, with each patient participant taking part in the trial for 6 months and the last follow-up due 12 months after the start of recruitment.
Set in general practices in Kerry and North Cork and in the Physiotherapy Department of University Hospital Kerry (UHK), a publicly funded hospital also in the South-West of Ireland.
A single arm feasibility study was chosen rather than a comparative design because the main focus was to resolve uncertainties about the acceptability and feasibility of the intervention itself, and its mode of delivery. A non-randomised design was deemed suitable as it was an opportunity to test the intervention with a greater number of HCP and patient participants.
Sample Size
As this is a feasibility study, a formal sample size calculation has not been carried out.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description KNEE-DEeP Intervention arm KNEE-DEeP intervention- Knowledge translation and exercise for early degenerative knee pain The KNEE-DEeP study delivers an intervention at both the level of the healthcare professional and the patient. Healthcare professionals (GPs and physiotherapists) will receive a educational workshop and resources to use with patient participants. Patients in the intervention arm will receive an 'enhanced consultation' with their GP and early access to a 'best practice' one-hour physiotherapy session in University Hospital Kerry, along with educational resources.
- Primary Outcome Measures
Name Time Method Change in physical function from baseline to 12 weeks as measured by Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS) Baseline and 12 weeks This 7-item measure of physical function is derived from the activities of daily living and sport/recreation subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS). Psychometric testing shows the KOOS-PS to be valid and reliable for use in groups with knee OA, making it an suitable tool for measuring knee-related function in this research. Scores range from 0 (extreme problems) to 100 (no problems).
- Secondary Outcome Measures
Name Time Method Change in knee pain from baseline to 24 weeks as measured by Knee Injury and Osteoarthritis Outcome Score Pain Subscale Baseline and 24 weeks This nine item subscale of the KOOS is scored (0 to 100) and reported individually. The KOOS subscales are valid, responsive and reliable questionnaires and has been used extensively knee OA and knee arthroscopy trials.
Change in pain self-efficacy from baseline to 24 weeks as measured by the Pain Self-efficacy (PSEQ 2-item short form) Baseline and 24 weeks The 2 items identified from the PSEQ reflect confidence in one's ability to work and lead a normal life despite pain and are scored on a 7-point Likert scale from "Not at all confident" (0) to "Completely confident" (6), with scores ranging from 0 to 12 (maximal confidence) to perform activity despite pain. This 2-item shortened form of the PSEQ is a valid, responsive and reliable questionnaires and has been used extensively in chronic musculoskeletal disorders research.
Change in physical function from baseline to 12 weeks as measured by Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS) Baseline and 24 weeks This 7-item measure of physical function is derived from the activities of daily living and sport/recreation subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS). Psychometric testing shows the KOOS-PS to be valid and reliable for use in groups with knee OA, making it an suitable tool for measuring knee-related function in this research. Scores range from 0 (extreme problems) to 100 (no problems).
Adherence to exercise and physical activity plan at 12 weeks 12 weeks Adherence to the exercise and physical activity plan agreed with the physiotherapists will be rated by the patient participant via questionnaire scored on an 11-point Numerical Rating Scale (0 = not at all and 10 = completely as instructed).
Use of health care and co-interventions for knee pain from baseline to 12 weeks 12 weeks A self-report checklist completed will record visits to health care providers (additional physiotherapy and GP consultations, other health professional or secondary care consultations), injection use, complementary therapies, use of prescription and over-the-counter medication, imaging, other participation in structured exercise between baseline and 12 weeks
Change in pain self-efficacy from baseline to 12 weeks as measured by the Pain Self-efficacy (PSEQ 2-item short form) Baseline and 12 weeks The 2 items identified from the PSEQ reflect confidence in one's ability to work and lead a normal life despite pain and are scored on a 7-point Likert scale from "Not at all confident" (0) to "Completely confident" (6), with scores ranging from 0 to 12 to perform activity despite pain. This 2-item shortened form of the PSEQ is a valid, responsive and reliable questionnaires and has been used extensively in chronic musculoskeletal disorders research.
Change in fear avoidance beliefs from baseline to 24 weeks as measured by the physical activity subscale of the Fear Avoidance Belief Questionnaire (FABQ) Baseline and 24 weeks This four-item physical activity sub-scale of the FABQ quantifies the level of fear about physical activity. While primarily studied in patients with low-back pain, it is a reliable scale to measure fear avoidance beliefs in knee OA.
Change in pain medication from baseline to 12 weeks 12 weeks Change in pain medication use from baseline to 12 weeks will be assessed with a 7-point Likert scale (much less to much more).
Change in knee pain from baseline to 12 weeks as measured by Knee Injury and Osteoarthritis Outcome Score Pain Subscale Baseline and 12 weeks This nine item subscale of the KOOS is scored (0 to 100) and reported individually. The KOOS subscales are valid, responsive and reliable questionnaires and has been used extensively knee OA and knee arthroscopy trials.
Change in fear avoidance beliefs from baseline to 12 weeks as measured by the physical activity subscale of the Fear Avoidance Belief Questionnaire (FABQ) Baseline and 12 weeks This four-item physical activity sub-scale of the FABQ quantifies the level of fear about physical activity. While primarily studied in patients with low-back pain, it is a reliable scale to measure fear avoidance beliefs in knee OA.
Patient Satisfaction with Care at 12 weeks 12 weeks Participants will be asked to rate "overall satisfaction with the care you received in this study" using a 7-point scale ranging from "extremely unsatisfied" to "extremely satisfied"
Use of health care and co-interventions for knee pain from 12 to 24 weeks 24 weeks A self-report checklist completed will record visits to health care providers (additional physiotherapy and GP consultations, other health professional or secondary care consultations), injection use, complementary therapies, and imaging between 12 and 24 weeks
Change in health related quality of life from baseline to 12 weeks as measured by the EuroQol Five-Dimensional Questionnaire (EQ-5D-5L) Baseline and 12 weeks Health-related quality of life will be measured with this generic health index, which comprises five dimensions of health (mobility, self-care, usual activities, pain or discomfort, anxiety or depression) and a Visual Analogue Scale (VAS) of current overall health status ranging from 0 (worst
imaginable health) to 100 (best imaginable health).Change in health related quality of life from baseline to 24 weeks as measured by the EuroQol Five-Dimensional Questionnaire (EQ-5D-5L) Baseline and 24 weeks Health-related quality of life will be measured with this generic health index, which comprises five dimensions of health (mobility, self-care, usual activities, pain or discomfort, anxiety or depression) and a Visual Analogue Scale (VAS) of current overall health status of current overall health status ranging from 0 (worst
imaginable health) to 100 (best imaginable health).
Trial Locations
- Locations (1)
University Hospital Kerry
🇮🇪Tralee, Kerry, Ireland