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

NCT06576557 | Recruiting

• 1 other identifier: 0000
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Meniscus; Degeneration

Keywords

Health Care Quality, Access, and Evaluation; Feasibility Studies; Exercise Therapy

Outcome Measures

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).

  Baseline and 12 weeks

Secondary Outcomes (14)

• 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

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

  Baseline and 12 weeks

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

  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)

  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)

  Baseline and 24 weeks

Other Outcomes (9)

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

  12 weeks

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

  12 weeks

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

  12 weeks

Study Arms (1)

KNEE-DEeP Intervention arm

EXPERIMENTAL

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.

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

Interventions

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.

KNEE-DEeP Intervention arm

Eligibility Criteria

• Age: 35 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Limerick: lead
• Health Research Board, Ireland: collaborator

Study Sites (1)

University Hospital Kerry

Tralee, Kerry, V92 NX94, Ireland

RECRUITING

Related Publications (18)

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  PMID: 22530986 BACKGROUND

• Wood G, Neilson J, Cottrell E, Hoole SP; Guideline Committee. Osteoarthritis in people over 16: diagnosis and management-updated summary of NICE guidance. BMJ. 2023 Jan 24;380:24. doi: 10.1136/bmj.p24. No abstract available.

  PMID: 36693668 BACKGROUND

• Perruccio AV, Stefan Lohmander L, Canizares M, Tennant A, Hawker GA, Conaghan PG, Roos EM, Jordan JM, Maillefert JF, Dougados M, Davis AM. The development of a short measure of physical function for knee OA KOOS-Physical Function Shortform (KOOS-PS) - an OARSI/OMERACT initiative. Osteoarthritis Cartilage. 2008 May;16(5):542-50. doi: 10.1016/j.joca.2007.12.014. Epub 2008 Feb 21.

  PMID: 18294869 BACKGROUND

• Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.

  PMID: 14613558 BACKGROUND

• Nicholas MK, McGuire BE, Asghari A. A 2-item short form of the Pain Self-efficacy Questionnaire: development and psychometric evaluation of PSEQ-2. J Pain. 2015 Feb;16(2):153-63. doi: 10.1016/j.jpain.2014.11.002. Epub 2014 Nov 14.

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  PMID: 8455963 BACKGROUND

• O'Leary H, Robinson K, Glynn L, Lenehan B, McCreesh K. "You're stuck in the middle here": a qualitative study of GPs' experiences of managing knee pain attributed to a degenerative meniscal tear. BMC Prim Care. 2023 Jun 21;24(1):127. doi: 10.1186/s12875-023-02075-9.

  PMID: 37344762 BACKGROUND

• O'Leary H, Toomey C, Ryan LG, Robinson K, Glynn L, French HP, McCreesh K. Knowledge translation and exercise for degenerative meniscal pathology and early osteoarthritis (KNEE-DEeP): Protocol for a single arm feasibility study. HRB Open Res. 2025 Jan 24;8:14. doi: 10.12688/hrbopenres.14049.1. eCollection 2025.

  PMID: 40028467 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Helen O'Leary, BSc Physio

  University of Limerick

  PRINCIPAL INVESTIGATOR

• Karen McCreesh, BSc Physio

  University of Limerick

  STUDY CHAIR

Central Study Contacts

Liam Ryan, BSc Physio

CONTACT

00 353 66 7184280; liamg.ryan@hse.ie

Fionnán Hallinan, BSc Physio

CONTACT

00 353 66 7184280; fionnans.hallinan@hse.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 28, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available 6 months after planned papers have been published (quantitive x 1 and qualitative x ). Data will remain available for 60 months
• Access Criteria: All requests from qualified researchers engaging in independent scientific research will be considered, and will be provided following review and approval of a research proposal. Access can be requested by contacting the principal investigator helen.oleary@ul.ie

Locations

IE (1)