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Clinical Trials/NCT02595099
NCT02595099
Completed
Not Applicable

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

University of Nottingham0 sites15 target enrollmentMay 20, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
University of Nottingham
Enrollment
15
Primary Endpoint
Acceptability
Status
Completed
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
May 20, 2016
End Date
December 30, 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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).
  • 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

Outcomes

Primary Outcomes

Acceptability

Time Frame: 8 weeks

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

Secondary Outcomes

  • Neuropathic Pain(8 weeks, 6 months)
  • Pain Catastrophising(8 weeks, 6 months)
  • WOMAC Index(8 weeks, 6 months)
  • health service use(8 weeks, 6 months)
  • self-efficacy(8 weeks, 6 months)
  • Pain Attitudes(8 weeks, 6 months)
  • Sleep quality(8 weeks, 6 months)
  • EQ-5D(8 weeks, 6 months)
  • Patient generated index(8 weeks, 6 months)
  • Anxiety and Depression(8 weeks, 6 months)

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