Mindfulness for Osteoarthritis-related Knee Pain

January 29, 2019 updated by: University of Nottingham

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: 8 weeks
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
Time Frame: 8 weeks, 6 months
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
Time Frame: 8 weeks, 6 months
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
Time Frame: 8 weeks, 6 months
The Arthritis self-efficacy scale; a 20 item questionnaire to measure self-efficacy.
8 weeks, 6 months
Pain Attitudes
Time Frame: 8 weeks, 6 months
The Survey of Pain Attitudes; a 30 item questionnaire assessing patients attitudes and beliefs about their pain.
8 weeks, 6 months
Pain Catastrophising
Time Frame: 8 weeks, 6 months
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
Time Frame: 8 weeks, 6 months
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
Time Frame: 8 weeks, 6 months
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
Time Frame: 8 weeks, 6 months
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
Time Frame: 8 weeks, 6 months
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
Time Frame: 8 weeks, 6 months
Service use questionnaire; a 10 item questionnaire to measure health and social care service use including medications.
8 weeks, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Collaborators

Nottingham University Hospitals NHS Trust

Investigators

  • Principal Investigator: Michelle Hall, University of Nottingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2016

Primary Completion (Actual)

September 6, 2016

Study Completion (Actual)

December 30, 2016

Study Registration Dates

First Submitted

October 30, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (Estimate)

November 3, 2015

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15098

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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