Health TrialsbyHealthPanel

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

ConditionsOsteoarthritis, KneeMeniscus; Degeneration
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-69
SponsorUniversity of Limerick

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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

    Other intervention

    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.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: KNEE-DEeP Intervention armExperimental treatment 1 intervention

Trial outcomes

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)

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).

Time frame
Baseline and 12 weeks

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)

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).

Time frame
Baseline and 24 weeks
2

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.

Time frame
Baseline and 12 weeks
3

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.

Time frame
Baseline and 24 weeks
4

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.

Time frame
Baseline and 12 weeks

Other outcomes

1

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.

Time frame
12 weeks
2

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.

Time frame
12 weeks
3

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

Time frame
12 weeks
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)

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

Time frame
12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Limerick

Lead sponsor

Health Research Board, Ireland

Collaborator

Source ClinicalTrials.gov
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