Clinical trial NCT02595099: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Chronic Pain
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Nottingham University Hospitals NHS Trust
First posted: 2015-11-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Acceptability
timeFrame: 8 weeks
Secondary outcomes:
measure: WOMAC Index
timeFrame: 8 weeks, 6 months
measure: Neuropathic Pain
timeFrame: 8 weeks, 6 months
measure: self-efficacy
timeFrame: 8 weeks, 6 months
measure: Pain Attitudes
timeFrame: 8 weeks, 6 months
measure: Pain Catastrophising
timeFrame: 8 weeks, 6 months
measure: Anxiety and Depression
timeFrame: 8 weeks, 6 months
measure: Sleep quality
timeFrame: 8 weeks, 6 months
measure: EQ-5D
timeFrame: 8 weeks, 6 months
measure: Patient generated index
timeFrame: 8 weeks, 6 months
measure: health service use
timeFrame: 8 weeks, 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Nottingham
name: Michelle Hall
role: PRINCIPAL_INVESTIGATOR
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