Knowledge Translation and Exercise for Degenerative Meniscal Tears and Early Osteoarthritis: KNEE-DEeP Study
NCT Number: NCT06576557
Acronym: KNEE-DEeP
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteoarthritis, Knee|Meniscus; Degeneration
Interventions: OTHER: KNEE-DEeP intervention- Knowledge translation and exercise for early degenerative knee pain
Sponsor: University of Limerick
Collaborators: Health Research Board, Ireland
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-06-01
Completion Date: 2025-02
Locations: University Hospital Kerry, Tralee, Kerry, V92 NX94, Ireland

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.

Primary Outcome Measures: Change in physical function from baseline to 12 weeks as measured by Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS), 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)., Baseline and 12 weeks
Secondary Outcome Measures: Change in physical function from baseline to 12 weeks as measured by Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS), 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)., Baseline and 24 weeks|Change in knee pain from baseline to 12 weeks as measured by Knee Injury and Osteoarthritis Outcome Score Pain Subscale, 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., Baseline and 12 weeks|Change in knee pain from baseline to 24 weeks as measured by Knee Injury and Osteoarthritis Outcome Score Pain Subscale, 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., Baseline and 24 weeks|Change in pain self-efficacy from baseline to 12 weeks as measured by the Pain Self-efficacy (PSEQ 2-item short form), 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., Baseline and 12 weeks|Change in pain self-efficacy from baseline to 24 weeks as measured by the Pain Self-efficacy (PSEQ 2-item short form), 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., Baseline and 24 weeks|Change in fear avoidance beliefs from baseline to 12 weeks as measured by the physical activity subscale of the Fear Avoidance Belief Questionnaire (FABQ), 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., Baseline and 12 weeks|Change in fear avoidance beliefs from baseline to 24 weeks as measured by the physical activity subscale of the Fear Avoidance Belief Questionnaire (FABQ), 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., Baseline 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), 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)., Baseline and 12 weeks|Change in health related quality of life from baseline to 24 weeks as measured by the EuroQol Five-Dimensional Questionnaire (EQ-5D-5L), 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)., Baseline and 24 weeks|Patient Satisfaction with Care at 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", 12 weeks|Adherence to exercise and physical activity plan at 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)., 12 weeks|Use of health care and co-interventions for knee pain from baseline to 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, 12 weeks|Use of health care and co-interventions for knee pain from 12 to 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, 24 weeks|Change in pain medication from baseline to 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)., 12 weeks
Other Outcome Measures: Feasibility of the intervention as rated by patient participants at 12 weeks using the Feasibility of Intervention Measure (FIM), The FIM is a 4-item scale that measures the extent to which a new intervention can be successfully delivered within a given setting. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean., 12 weeks|Feasibility of the intervention with clinician (physiotherapist and GP) participants as measured using the Feasibility of Intervention Measure (FIM), The FIM is a 4-item scale that measures the extent to which a new intervention can be successfully delivered within a given setting. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). A mean score is calculated., 12 weeks|The acceptability of the intervention to patient participants will be measured at 12 weeks using the Theoretical Framework of Acceptability (TFA), Generic questionnaire adapted to assess KNEE-DEeP intervention acceptability from the perspectives of intervention recipients measured using a five-point Likert scale from 'Strongly disagree' to 'Strongly agree, 12 weeks|The acceptability of the intervention to HCP (physiotherapist and GP) participants will be measured at 12 weeks using the Theoretical Framework of Acceptability (TFA), Generic questionnaire adapted to assess KNEE-DEeP intervention acceptability from the perspectives of intervention recipients, measured using a five-point Likert scale from 'Strongly disagree' to 'Strongly agree, 12 weeks|Fidelity of delivery and receipt of the KNEE-DEeP GP 'enhanced consultation' will be assessed by a checklist completed by the GP (fidelity of delivery) and patient (fidelity of receipt) at baseline (0 weeks), Bespoke checklist documenting the key elements of the GP 'enhanced consultation', Baseline|Fidelity of delivery of the KNEE-DEeP physiotherapy 'best practice' session will be assessed by a bespoke checklist completed by the physiotherapist post-intervention delivery, Bespoke checklist documenting the key elements of the physiotherapy 'best practice' session, Immediately post-intervention|Qualitative data on intervention acceptability and feasibility will be collected via semi-structured interviews with patient participants, A twenty minute interview conducted online or via telephone question will explore participants experience of the intervention. A subset of patients will be invited to interview., No fixed timepoint, qualitative data will be collected between 2 weeks and 8 weeks post intervention receipt|Qualitative data on intervention acceptability and feasibility will be collected via semi-structured interviews with a sub-set of participating health care professionals (GP and physiotherapists), A twenty minute interview conducted online or via telephone question will explore participants experience of the intervention, both receiving the educational workshop and training and delivering the patient intervention, No fixed timepoint, qualitative data will be collected from health care professionals after at least 3-month of study participation|Adverse events reported to the research team will be recorded in an adverse events log throughout the duration of the study, Adverse events can be reported to the research team by participating GPs, physiotherapists of patients. Defined as any problem that participants believe was caused by the intervention (exercise or advice) and required them to seek treatment and/or lasted for two or more days., Duration of the study and followup period (approx 12 months)