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Mindfulness for Osteoarthritis-related Knee Pain

Primary Purpose

Osteoarthritis, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness training
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults over 18 years, there is no upper age limit.
  • Osteoarthritis of the knee (defined as joint space narrowing and osteophytes in 1 or more compartment) and moderate to severe knee pain (defined as 40-80mm on a 100mm visual analogue scale).

Or

  • Persistent moderate to severe knee pain (40 - 80mm on a 100mm visual analogue scale), one year following total knee replacement

Exclusion Criteria:

  • People who have previously participated in a 8 week Mindfulness course
  • Terminal illness and other conditions leading to incapacity to participate in the study
  • Acute knee injury, knee joint surgery or steroid injection to the knee within previous 3 months or currently on a waiting list for knee joint surgery
  • Inflammatory arthritis (eg Rheumatoid arthritis or psoriatic arthritis)
  • Patients who are unable to provide informed consent
  • Patients who are unable to communicate in English, as the intervention is delivered in English

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Mindfulness training

    Arm Description

    8 week programme of Mindfulness training

    Outcomes

    Primary Outcome Measures

    Acceptability
    This will be determined by the number of participants who completed the intervention and from focus group discussions.

    Secondary Outcome Measures

    WOMAC Index
    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC); a 24 item self-administered health status measure widely used in assessing pain, stiffness, and function in patients with OA of the hip or knee.
    Neuropathic Pain
    Pain Detect Questionnaire; a 12 item patient-based, screening questionnaire to determine the presence of neuropathic pain components validated in knee OA
    self-efficacy
    The Arthritis self-efficacy scale; a 20 item questionnaire to measure self-efficacy.
    Pain Attitudes
    The Survey of Pain Attitudes; a 30 item questionnaire assessing patients attitudes and beliefs about their pain.
    Pain Catastrophising
    Pain catastrophizing scale for adults; a 13 item self-report measure of the degree to which people experience pain adopt exaggerated negative interpretations of the pain. and beliefs about their pain.
    Anxiety and Depression
    Hospital Anxiety and Depression (HAD) scale; A 14 item, two dimension scale developed to identify depression and anxiety among physically ill patients. Validated in several patient populations.
    Sleep quality
    Pittsburgh sleep quality index; a 18 item, self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.
    EQ-5D
    Euro-Qol quality of life ; a 5 item standardised instrument applicable to a wide range of health conditions and treatments for use as a measure of health outcome.
    Patient generated index
    The Patient Generated Index; an individualised instrument which rates up to 5 QOL items chosen by the respondent as being important.
    health service use
    Service use questionnaire; a 10 item questionnaire to measure health and social care service use including medications.

    Full Information

    First Posted
    October 30, 2015
    Last Updated
    January 29, 2019
    Sponsor
    University of Nottingham
    Collaborators
    Nottingham University Hospitals NHS Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02595099
    Brief Title
    Mindfulness for Osteoarthritis-related Knee Pain
    Official Title
    Feasibility and Acceptability of a Mindfulness-based Intervention for People With Osteoarthritis (OA) Related Knee Pain.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 20, 2016 (Actual)
    Primary Completion Date
    September 6, 2016 (Actual)
    Study Completion Date
    December 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Nottingham
    Collaborators
    Nottingham University Hospitals NHS Trust

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this project is to investigate the feasibility and acceptability of a Mindfulness based intervention for people who are attending secondary care with Osteoarthritis (OA)-related knee pain.
    Detailed Description
    This study will explore the acceptability of a novel intervention (an 8-week programme of Mindfulness training) for people with Osteoarthritis(OA)-related knee pain. Mindfulness interventions provide intensive training in mindfulness meditation and its applications for coping with stress, illness and pain in day to day life. The aim of the intervention is not reduce the severity of pain per se, but to change how an individual responds and copes with pain. If effective, patients may report improvements in pain, sleep, quality of life and their ability to cope with pain in daily life. Before carrying out a study to determine if such an intervention is effective, it is important to explore whether it is acceptable to patients. Treatments for OA knee are usually targeted at the painful joint e.g medication, injections, physiotherapy, surgery and ultimately total knee replacement (TKR), so some patients may not expect a programme based on meditation practice to help. The investigators will recruit two groups of patients with OA-related knee pain from hospital clinics, (i) those with moderate-severe knee pain who have not yet had a TKR and (ii) those who have had a TKR who have persistent pain after one-year. All participants will complete baseline assessments before commencing an eight-week group based programme of Mindfulness training, delivered by an NHS physiotherapist who is also a trained Mindfulness teacher. Participants will have daily meditation practices to carry out at home. Follow-up questionnaires will be repeated after the intervention and again at 6 months. After the intervention, the investigators will conduct group discussions with some of the participants to explore their expectations and experiences of the intervention and the study. Participants will be in the study for approximately 8 months (from time of recruitment) and the study will last 12 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Chronic Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mindfulness training
    Arm Type
    Experimental
    Arm Description
    8 week programme of Mindfulness training
    Intervention Type
    Other
    Intervention Name(s)
    Mindfulness training
    Intervention Description
    group-based training programme, 2.5 hours delivered weekly for 8 weeks
    Primary Outcome Measure Information:
    Title
    Acceptability
    Description
    This will be determined by the number of participants who completed the intervention and from focus group discussions.
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    WOMAC Index
    Description
    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC); a 24 item self-administered health status measure widely used in assessing pain, stiffness, and function in patients with OA of the hip or knee.
    Time Frame
    8 weeks, 6 months
    Title
    Neuropathic Pain
    Description
    Pain Detect Questionnaire; a 12 item patient-based, screening questionnaire to determine the presence of neuropathic pain components validated in knee OA
    Time Frame
    8 weeks, 6 months
    Title
    self-efficacy
    Description
    The Arthritis self-efficacy scale; a 20 item questionnaire to measure self-efficacy.
    Time Frame
    8 weeks, 6 months
    Title
    Pain Attitudes
    Description
    The Survey of Pain Attitudes; a 30 item questionnaire assessing patients attitudes and beliefs about their pain.
    Time Frame
    8 weeks, 6 months
    Title
    Pain Catastrophising
    Description
    Pain catastrophizing scale for adults; a 13 item self-report measure of the degree to which people experience pain adopt exaggerated negative interpretations of the pain. and beliefs about their pain.
    Time Frame
    8 weeks, 6 months
    Title
    Anxiety and Depression
    Description
    Hospital Anxiety and Depression (HAD) scale; A 14 item, two dimension scale developed to identify depression and anxiety among physically ill patients. Validated in several patient populations.
    Time Frame
    8 weeks, 6 months
    Title
    Sleep quality
    Description
    Pittsburgh sleep quality index; a 18 item, self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.
    Time Frame
    8 weeks, 6 months
    Title
    EQ-5D
    Description
    Euro-Qol quality of life ; a 5 item standardised instrument applicable to a wide range of health conditions and treatments for use as a measure of health outcome.
    Time Frame
    8 weeks, 6 months
    Title
    Patient generated index
    Description
    The Patient Generated Index; an individualised instrument which rates up to 5 QOL items chosen by the respondent as being important.
    Time Frame
    8 weeks, 6 months
    Title
    health service use
    Description
    Service use questionnaire; a 10 item questionnaire to measure health and social care service use including medications.
    Time Frame
    8 weeks, 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults over 18 years, there is no upper age limit. Osteoarthritis of the knee (defined as joint space narrowing and osteophytes in 1 or more compartment) and moderate to severe knee pain (defined as 40-80mm on a 100mm visual analogue scale). Or Persistent moderate to severe knee pain (40 - 80mm on a 100mm visual analogue scale), one year following total knee replacement Exclusion Criteria: People who have previously participated in a 8 week Mindfulness course Terminal illness and other conditions leading to incapacity to participate in the study Acute knee injury, knee joint surgery or steroid injection to the knee within previous 3 months or currently on a waiting list for knee joint surgery Inflammatory arthritis (eg Rheumatoid arthritis or psoriatic arthritis) Patients who are unable to provide informed consent Patients who are unable to communicate in English, as the intervention is delivered in English
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michelle Hall
    Organizational Affiliation
    University of Nottingham
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21265650
    Citation
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    PubMed Identifier
    25406303
    Citation
    Fogarty FA, Booth RJ, Gamble GD, Dalbeth N, Consedine NS. The effect of mindfulness-based stress reduction on disease activity in people with rheumatoid arthritis: a randomised controlled trial. Ann Rheum Dis. 2015 Feb;74(2):472-4. doi: 10.1136/annrheumdis-2014-205946. Epub 2014 Nov 18. No abstract available.
    Results Reference
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    PubMed Identifier
    22186709
    Citation
    Zangi HA, Mowinckel P, Finset A, Eriksson LR, Hoystad TO, Lunde AK, Hagen KB. A mindfulness-based group intervention to reduce psychological distress and fatigue in patients with inflammatory rheumatic joint diseases: a randomised controlled trial. Ann Rheum Dis. 2012 Jun;71(6):911-7. doi: 10.1136/annrheumdis-2011-200351. Epub 2011 Dec 20.
    Results Reference
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    PubMed Identifier
    25136324
    Citation
    Schutze R, Slater H, O'Sullivan P, Thornton J, Finlay-Jones A, Rees CS. Mindfulness-Based Functional Therapy: a preliminary open trial of an integrated model of care for people with persistent low back pain. Front Psychol. 2014 Aug 4;5:839. doi: 10.3389/fpsyg.2014.00839. eCollection 2014.
    Results Reference
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    PubMed Identifier
    26009534
    Citation
    Bawa FL, Mercer SW, Atherton RJ, Clague F, Keen A, Scott NW, Bond CM. Does mindfulness improve outcomes in patients with chronic pain? Systematic review and meta-analysis. Br J Gen Pract. 2015 Jun;65(635):e387-400. doi: 10.3399/bjgp15X685297.
    Results Reference
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    PubMed Identifier
    21954151
    Citation
    Sofat N, Ejindu V, Kiely P. What makes osteoarthritis painful? The evidence for local and central pain processing. Rheumatology (Oxford). 2011 Dec;50(12):2157-65. doi: 10.1093/rheumatology/ker283. Epub 2011 Sep 27.
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    PubMed Identifier
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    Citation
    Finan PH, Buenaver LF, Bounds SC, Hussain S, Park RJ, Haque UJ, Campbell CM, Haythornthwaite JA, Edwards RR, Smith MT. Discordance between pain and radiographic severity in knee osteoarthritis: findings from quantitative sensory testing of central sensitization. Arthritis Rheum. 2013 Feb;65(2):363-72. doi: 10.1002/art.34646.
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    Citation
    Murphy LB, Sacks JJ, Brady TJ, Hootman JM, Chapman DP. Anxiety and depression among US adults with arthritis: prevalence and correlates. Arthritis Care Res (Hoboken). 2012 Jul;64(7):968-76. doi: 10.1002/acr.21685.
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    Citation
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    Citation
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    Citation
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    Citation
    Hawker G, Wright J, Coyte P, Paul J, Dittus R, Croxford R, Katz B, Bombardier C, Heck D, Freund D. Health-related quality of life after knee replacement. J Bone Joint Surg Am. 1998 Feb;80(2):163-73. doi: 10.2106/00004623-199802000-00003.
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    Citation
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    Mindfulness for Osteoarthritis-related Knee Pain

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