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
About this trial
This is an interventional treatment trial for Osteoarthritis
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
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
NCT ID
NCT02595099
First Posted
October 30, 2015
Last Updated
January 29, 2019
Sponsor
University of Nottingham
Collaborators
Nottingham University Hospitals NHS Trust
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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Results Reference
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Citation
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Results Reference
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PubMed Identifier
22186709
Citation
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Results Reference
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PubMed Identifier
25136324
Citation
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Results Reference
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PubMed Identifier
26009534
Citation
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21954151
Citation
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Citation
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Citation
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Mindfulness for Osteoarthritis-related Knee Pain
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