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NCT Number: NCT06576557

Knowledge Translation and Exercise for Degenerative Meniscal Tears and Early Osteoarthritis: KNEE-DEeP Study

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Meniscus; Degeneration Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

35 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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:

  • Determine the acceptability of the intervention content and delivery to HCPs and patients
  • Determine adherence of GPs and physiotherapists to study processes around intervention delivery to patients
  • Assess fidelity related to intervention delivery and intervention receipt, from the perspectives of HCPs and patients.
  • Determine if data collection procedures and outcome measures are feasible and acceptable to HCPs and patients
  • Determine feasibility of HCP and patients' recruitment and retention procedures
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KNEE-DEeP intervention- Knowledge translation and exercise for early degenerative knee pain

Other

The intervention for health care professionals (GPs and physiotherapists) will consist of training and education. The two-hour educational workshop for GPs will focus on diagnosis and management of patients with early degenerative knee pain, and enhancing communication skills. Training for physiotherapists will focus on delivery of a 'best practice' session. The patient participant intervention will consist of an 'enhanced consultation' delivered by the GP. This will involve a physical exam, key educational messages, written information and a treatment plan. Patients will receive a single session of physiotherapy within 2 weeks of referral from their GP. This 'best practice' session will focus on self-management skills, targeted patient education, goal setting, action planning and exercise prescription.

Primary outcomes

  1. Change in physical function from baseline to 12 weeks as measured by Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS)

    Time frame: 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 outcomes

  1. Change in physical function from baseline to 12 weeks as measured by Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS)

    Time frame: 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).

  2. Change in knee pain from baseline to 12 weeks as measured by Knee Injury and Osteoarthritis Outcome Score Pain Subscale

    Time frame: 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.

  3. Change in knee pain from baseline to 24 weeks as measured by Knee Injury and Osteoarthritis Outcome Score Pain Subscale

    Time frame: 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.

  4. Change in pain self-efficacy from baseline to 12 weeks as measured by the Pain Self-efficacy (PSEQ 2-item short form)

    Time frame: 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.

  5. Change in pain self-efficacy from baseline to 24 weeks as measured by the Pain Self-efficacy (PSEQ 2-item short form)

    Time frame: 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.

  6. Change in fear avoidance beliefs from baseline to 12 weeks as measured by the physical activity subscale of the Fear Avoidance Belief Questionnaire (FABQ)

    Time frame: 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.

  7. Change in fear avoidance beliefs from baseline to 24 weeks as measured by the physical activity subscale of the Fear Avoidance Belief Questionnaire (FABQ)

    Time frame: 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.

  8. Change in health related quality of life from baseline to 12 weeks as measured by the EuroQol Five-Dimensional Questionnaire (EQ-5D-5L)

    Time frame: 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).

  9. Change in health related quality of life from baseline to 24 weeks as measured by the EuroQol Five-Dimensional Questionnaire (EQ-5D-5L)

    Time frame: 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).

  10. Patient Satisfaction with Care at 12 weeks

    Time frame: 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"

  11. Adherence to exercise and physical activity plan at 12 weeks

    Time frame: 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. Use of health care and co-interventions for knee pain from baseline to 12 weeks

    Time frame: 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

  13. Use of health care and co-interventions for knee pain from 12 to 24 weeks

    Time frame: 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

  14. Change in pain medication from baseline to 12 weeks

    Time frame: 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).

Other outcomes

  1. Feasibility of the intervention as rated by patient participants at 12 weeks using the Feasibility of Intervention Measure (FIM)

    Time frame: 12 weeks

    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.

  2. Feasibility of the intervention with clinician (physiotherapist and GP) participants as measured using the Feasibility of Intervention Measure (FIM)

    Time frame: 12 weeks

    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.

  3. The acceptability of the intervention to patient participants will be measured at 12 weeks using the Theoretical Framework of Acceptability (TFA)

    Time frame: 12 weeks

    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

  4. The acceptability of the intervention to HCP (physiotherapist and GP) participants will be measured at 12 weeks using the Theoretical Framework of Acceptability (TFA)

    Time frame: 12 weeks

    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

  5. 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)

    Time frame: Baseline

    Bespoke checklist documenting the key elements of the GP 'enhanced consultation'

  6. 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

    Time frame: Immediately post-intervention

    Bespoke checklist documenting the key elements of the physiotherapy 'best practice' session

  7. Qualitative data on intervention acceptability and feasibility will be collected via semi-structured interviews with patient participants

    Time frame: No fixed timepoint, qualitative data will be collected between 2 weeks and 8 weeks post intervention receipt

    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.

  8. 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)

    Time frame: No fixed timepoint, qualitative data will be collected from health care professionals after at least 3-month of study participation

    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

  9. Adverse events reported to the research team will be recorded in an adverse events log throughout the duration of the study

    Time frame: Duration of the study and followup period (approx 12 months)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fionnán Hallinan, BSc Physio

CONTACT

[email protected]

00 353 66 7184280

Liam Ryan, BSc Physio

CONTACT

[email protected]

00 353 66 7184280

Sponsors and collaborators

Lead sponsor

University of Limerick

Other

Collaborators

  • Health Research Board, Ireland

Registry information

Official study title

Knowledge Translation and Exercise for Degenerative Meniscal Tears and Early Osteoarthritis: the KNEE-DEeP Feasibility Study

Acronym: KNEE-DEeP

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 28, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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