Actively Recruiting

Phase Not Applicable
Age: 35Years - 69Years
All Genders
ID06576557

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

Led by University of Limerick · Updated on 2024-08-28

36

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

U

University of Limerick

Lead Sponsor

H

Health Research Board, Ireland

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a new approach called the KNEE-DEeP intervention to improve care for adults aged 35 to 69 who experience knee pain caused by degenerative meniscal tears or early osteoarthritis. This condition is common in middle-aged and older adults, and although exercise is recommended, many patients currently receive surgery referrals instead of physiotherapy. The study aims to test whether the KNEE-DEeP program can be delivered as planned and is acceptable to patients, general practitioners (GPs), and physiotherapists before conducting a larger trial. The intervention involves training GPs and physiotherapists through educational workshops to enhance their consultations and care delivery. Patients will receive an 'enhanced consultation' from their GP, including a physical exam, education, written information, and a treatment plan. They will also have early access to a single 'best practice' physiotherapy session focusing on self-management strategies, goal setting, and exercise prescription within two weeks of referral. The study is a single-arm feasibility trial conducted in general practices and a hospital physiotherapy department in Ireland. Participants will be followed for six months with assessments at the start, 12 weeks, and 24 weeks. Researchers will collect data on physical function, knee pain, pain self-efficacy, fear avoidance beliefs, quality of life, satisfaction with care, exercise adherence, healthcare use, and pain medication changes. Questionnaires and interviews with patients, GPs, and physiotherapists will evaluate the intervention's acceptability and feasibility. The total study duration for each patient is six months, with recruitment planned over six months and completion expected 12 months after starting.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 35Years - 69Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Attended their GP with an episode of non-traumatic knee pain
  • Have knee pain attributed to a degenerative meniscal tear or early degenerative changes based on GP clinical assessment
  • Aged between 35 and 69 years inclusive
Not Eligible

You will not qualify if you...

  • Recent trauma likely to be associated with considerable tissue damage
  • Meeting clinical criteria for established knee osteoarthritis per American College of Rheumatology
  • Moderate or advanced knee osteoarthritis on X-ray (Kellgren-Lawrence Grade 3 or higher)
  • Acutely swollen or locked knee, or suspected ligament injury on physical exam
  • Inflammatory arthritis
  • Surgery or significant trauma to the knee in the past 2 years
  • Pregnancy
  • Unable to communicate in English
  • Preference for accessing private physiotherapy before the study session
  • GPs or physiotherapists not within 50 km of University Hospital Kerry or unwilling to attend training workshop

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 2 weeks

Participants receive an enhanced consultation with their GP that includes a physical exam, key educational messages, written information, and a treatment plan. Within 2 weeks of GP referral, participants attend a single one-hour physiotherapy session focused on self-management skills, education, goal setting, action planning, and exercise prescription.

1 visit with GP and 1 physiotherapy session (in-person)

Follow-up

Duration - Up to 24 weeks after treatment

Participants are assessed at 12 weeks and 24 weeks to evaluate changes in physical function, knee pain, pain self-efficacy, fear avoidance beliefs, health-related quality of life, patient satisfaction, adherence to exercise, use of healthcare, and pain medication.

2 visits at 12 and 24 weeks (in-person or remote)

Trial Site Locations

Total: 1 location

1

University Hospital Kerry

Tralee, Kerry, Ireland, V92 NX94

Actively Recruiting

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Research Team

L

Liam Ryan, BSc Physio

F

Fionnán Hallinan, BSc Physio

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

1

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Published Research Related To This Trial

Prevalence of knee osteoarthritis features on magnetic resonance imaging in asymptomatic uninjured adults: a systematic review and meta-analysis.

Adam G Culvenor, Britt Elin Øiestad, Harvi F Hart...

https://pubmed.ncbi.nlm.nih.gov/29886437

The clinical importance of meniscal tears demonstrated by magnetic resonance imaging in osteoarthritis of the knee.

Timothy Bhattacharyya, Daniel Gale, Peter Dewire...

https://pubmed.ncbi.nlm.nih.gov/12533565

"You'd be better off to do the keyhole and make a good job of it" a qualitative study of the beliefs and treatment expectations of patients attending secondary care with degenerative meniscal tears.

Helen O'Leary, Liam G Ryan, Katie Robinson...

https://pubmed.ncbi.nlm.nih.gov/33161307

A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance.

Kathryn Skivington, Lynsay Matthews, Sharon Anne Simpson...

https://pubmed.ncbi.nlm.nih.gov/34593508

The development of a short measure of physical function for knee OA KOOS-Physical Function Shortform (KOOS-PS) - an OARSI/OMERACT initiative.

A V Perruccio, L Stefan Lohmander, M Canizares...

https://pubmed.ncbi.nlm.nih.gov/18294869