Mindfulness for Osteoarthritis-related Knee Pain

Study Overview
=================
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.

Official Title
-----------------
Feasibility and Acceptability of a Mindfulness-based Intervention for People With Osteoarthritis (OA) Related Knee Pain.

Conditions
-----------------
Osteoarthritis, Chronic Pain

Intervention / Treatment
-----------------
* Other: Mindfulness training


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness training<br>8 week programme of Mindfulness training | Other: Mindfulness training<br>* group-based training programme, 2.5 hours delivered weekly for 8 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability | This will be determined by the number of participants who completed the intervention and from focus group discussions. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks, 6 months | 
| Neuropathic Pain | Pain Detect Questionnaire; a 12 item patient-based, screening questionnaire to determine the presence of neuropathic pain components validated in knee OA | 8 weeks, 6 months | 
| self-efficacy | The Arthritis self-efficacy scale; a 20 item questionnaire to measure self-efficacy. | 8 weeks, 6 months | 
| Pain Attitudes | The Survey of Pain Attitudes; a 30 item questionnaire assessing patients attitudes and beliefs about their pain. | 8 weeks, 6 months | 
| 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. | 8 weeks, 6 months | 
| 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. | 8 weeks, 6 months | 
| Sleep quality | Pittsburgh sleep quality index; a 18 item, self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. | 8 weeks, 6 months | 
| 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. | 8 weeks, 6 months | 
| Patient generated index | The Patient Generated Index; an individualised instrument which rates up to 5 QOL items chosen by the respondent as being important. | 8 weeks, 6 months | 
| health service use | Service use questionnaire; a 10 item questionnaire to measure health and social care service use including medications. | 8 weeks, 6 months |