Osteoarthritis, KneeKNEE-DEePNCT06576557
Knowledge Translation and Exercise for Degenerative Meniscal Tears and Early Osteoarthritis: KNEE-DEeP Study
A study testing KNEE-DEeP intervention- Knowledge translation and exercise for early degenerative knee pain in people with Osteoarthritis, Knee and Meniscus; Degeneration, run by University of Limerick at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 69 years
- Conditions the study is for
- Osteoarthritis, Knee, Meniscus; Degeneration
- What is being tested?
- KNEE-DEeP intervention- Knowledge translation and exercise for early degenerative knee pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIreland
- Study dates
- 1 Jun 2024to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
University Hospital Kerry
Tralee, Kerry, V92 NX94
Liam Ryan, BSc Physio, 00 353 66 7184280, liamg.ryan@hse.ie
Mary Barrett, BSc Physio, 00 353 7184280, mary.kilkennybarrett@hse.ie
About this study
Official title: Knowledge Translation and Exercise for Degenerative Meniscal Tears and Early Osteoarthritis: the KNEE-DEeP Feasibility 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.
Read the detailed description
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.
- Conditions
- Osteoarthritis, Knee, Meniscus; Degeneration
- Being tested
- KNEE-DEeP intervention- Knowledge translation and exercise for early degenerative knee pain
- Keywords
- Health Care Quality, Access, and Evaluation, Feasibility Studies, Exercise Therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KNEE-DEeP intervention- Knowledge translation and exercise for early degenerative knee painOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: KNEE-DEeP intervention- Knowledge translation and exercise for early degenerative knee pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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"
Measured: 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).
Measured: 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
Measured: 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
Measured: 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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start1 Jun 2024
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Board, Ireland
- Responsible party
- Sponsor
- Investigators
- Helen O'Leary, BSc Physio, Principal investigator, University of LimerickKaren McCreesh, BSc Physio, Study chair, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576557
- Sponsor's protocol ID
- 0000
- Acronym
- KNEE-DEeP
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request once the study has been completed. Available dataset will consist of anonymised IPD relating to patient clinical outcome measures. Due to the small number of participating clinicians, data gathered from participating clinicians will not be made available.
Publications
Culvenor AG, Oiestad BE, Hart HF, Stefanik JJ, Guermazi A, Crossley KM. Prevalence of knee osteoarthritis features on magnetic resonance imaging in asymptomatic uninjured adults: a systematic review and meta-analysis. Br J Sports Med. 2019 Oct;53(20):1268-1278. doi: 10.1136/bjsports-2018-099257. Epub 2018 Jun 9.
PubMed 29886437Siemieniuk RAC, Harris IA, Agoritsas T, Poolman RW, Brignardello-Petersen R, Van de Velde S, Buchbinder R, Englund M, Lytvyn L, Quinlan C, Helsingen L, Knutsen G, Olsen NR, Macdonald H, Hailey L, Wilson HM, Lydiatt A, Kristiansen A. Arthroscopic surgery for degenerative knee arthritis and meniscal tears: a clinical practice guideline. BMJ. 2017 May 10;357:j1982. doi: 10.1136/bmj.j1982. No abstract available.
PubMed 28490431Bhattacharyya T, Gale D, Dewire P, Totterman S, Gale ME, McLaughlin S, Einhorn TA, Felson DT. The clinical importance of meniscal tears demonstrated by magnetic resonance imaging in osteoarthritis of the knee. J Bone Joint Surg Am. 2003 Jan;85(1):4-9. doi: 10.2106/00004623-200301000-00002.
PubMed 12533565Keavy R, Horton R, Al-Dadah O. The prevalence of musculoskeletal presentations in general practice: an epidemiological study. Fam Pract. 2023 Feb 9;40(1):68-74. doi: 10.1093/fampra/cmac055.
PubMed 35747902O'Leary H, Ryan LG, Robinson K, Conroy EJ, McCreesh K. "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. Musculoskelet Sci Pract. 2021 Feb;51:102281. doi: 10.1016/j.msksp.2020.102281. Epub 2020 Oct 27.
PubMed 33161307Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.
PubMed 34593508Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.
PubMed 21513547Cane J, O'Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci. 2012 Apr 24;7:37. doi: 10.1186/1748-5908-7-37.
PubMed 22530986Wood 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.
PubMed 36693668Perruccio 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.
PubMed 18294869Roos 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.
PubMed 14613558Nicholas 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.
PubMed 25463701Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459Sekhon M, Cartwright M, Francis JJ. Development of a theory-informed questionnaire to assess the acceptability of healthcare interventions. BMC Health Serv Res. 2022 Mar 1;22(1):279. doi: 10.1186/s12913-022-07577-3.
PubMed 35232455Hurst NP, Kind P, Ruta D, Hunter M, Stubbings A. Measuring health-related quality of life in rheumatoid arthritis: validity, responsiveness and reliability of EuroQol (EQ-5D). Br J Rheumatol. 1997 May;36(5):551-9. doi: 10.1093/rheumatology/36.5.551.
PubMed 9189057
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge Translation and Exercise for Degenerative Meniscal Tears and Early Osteoarthritis: the KNEE-DEeP Feasibility Study
- ClinicalTrials.gov ID
- NCT06576557
- Acronym / sponsor ID
- KNEE-DEeP / 0000
- Conditions
- Osteoarthritis, Knee, Meniscus; Degeneration
- Keywords
- Health Care Quality, Access, and Evaluation, Feasibility Studies, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Collaborators
- Health Research Board, Ireland
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KNEE-DEeP Intervention arm | Experimental | Other: KNEE-DEeP intervention- Knowledge translation and exercise for early degenerative knee painThe 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. |
Who may qualify
- Ages
- 35 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KNEE-DEeP intervention- Knowledge translation and exercise for early degenerative knee painThe 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. | Other | KNEE-DEeP Intervention arm |
Primary outcome
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).
14 secondary outcomes
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
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
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
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
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
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
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
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
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
Patient Satisfaction with Care at 12 weeks
Time frame: 12 weeks
Adherence to exercise and physical activity plan at 12 weeks
Time frame: 12 weeks
Use of health care and co-interventions for knee pain from baseline to 12 weeks
Time frame: 12 weeks
Use of health care and co-interventions for knee pain from 12 to 24 weeks
Time frame: 24 weeks
Change in pain medication from baseline to 12 weeks
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Background: PubMed 29886437Culvenor AG, Oiestad BE, Hart HF, Stefanik JJ, Guermazi A, Crossley KM. Prevalence of knee osteoarthritis features on magnetic resonance imaging in asymptomatic uninjured adults: a systematic review and meta-analysis. Br J Sports Med. 2019 Oct;53(20):1268-1278. doi: 10.1136/bjsports-2018-099257. Epub 2018 Jun 9.
- Background: PubMed 28490431Siemieniuk RAC, Harris IA, Agoritsas T, Poolman RW, Brignardello-Petersen R, Van de Velde S, Buchbinder R, Englund M, Lytvyn L, Quinlan C, Helsingen L, Knutsen G, Olsen NR, Macdonald H, Hailey L, Wilson HM, Lydiatt A, Kristiansen A. Arthroscopic surgery for degenerative knee arthritis and meniscal tears: a clinical practice guideline. BMJ. 2017 May 10;357:j1982. doi: 10.1136/bmj.j1982. No abstract available.
- Background: PubMed 12533565Bhattacharyya T, Gale D, Dewire P, Totterman S, Gale ME, McLaughlin S, Einhorn TA, Felson DT. The clinical importance of meniscal tears demonstrated by magnetic resonance imaging in osteoarthritis of the knee. J Bone Joint Surg Am. 2003 Jan;85(1):4-9. doi: 10.2106/00004623-200301000-00002.
- Background: PubMed 35747902Keavy R, Horton R, Al-Dadah O. The prevalence of musculoskeletal presentations in general practice: an epidemiological study. Fam Pract. 2023 Feb 9;40(1):68-74. doi: 10.1093/fampra/cmac055.
- Background: PubMed 33161307O'Leary H, Ryan LG, Robinson K, Conroy EJ, McCreesh K. "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. Musculoskelet Sci Pract. 2021 Feb;51:102281. doi: 10.1016/j.msksp.2020.102281. Epub 2020 Oct 27.
- Background: PubMed 34593508Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.
- Background: PubMed 21513547Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.
- Background: PubMed 22530986Cane J, O'Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci. 2012 Apr 24;7:37. doi: 10.1186/1748-5908-7-37.
- Background: PubMed 36693668Wood 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.
- Background: PubMed 18294869Perruccio 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.
- Background: PubMed 14613558Roos 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.
- Background: PubMed 25463701Nicholas 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.
- Individual participant dataSharing planned: Yes. The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request once the study has been completed. Available dataset will consist of anonymised IPD relating to patient clinical outcome measures. Due to the small number of participating clinicians, data gathered from participating clinicians will not be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen O'Leary, BSc Physio principal investigator
University of Limerick
Karen McCreesh, BSc Physio study chair
University of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KNEE-DEeP intervention- Knowledge translation and exercise for early degenerative knee pain in people with Osteoarthritis, Knee and Meniscus; Degeneration, run by University of Limerick at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liam Ryan, BSc Physio (00 353 66 7184280, liamg.ryan@hse.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06576557, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.