Mindfulness training
Othergroup-based training programme, 2.5 hours delivered weekly for 8 weeks
NCT Number: NCT02595099
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Or
Exclusion criteria
group-based training programme, 2.5 hours delivered weekly for 8 weeks
Time frame: 8 weeks
This will be determined by the number of participants who completed the intervention and from focus group discussions.
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.
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
Time frame: 8 weeks, 6 months
The Arthritis self-efficacy scale; a 20 item questionnaire to measure self-efficacy.
Time frame: 8 weeks, 6 months
The Survey of Pain Attitudes; a 30 item questionnaire assessing patients attitudes and beliefs about their pain.
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.
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.
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.
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.
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.
Time frame: 8 weeks, 6 months
Service use questionnaire; a 10 item questionnaire to measure health and social care service use including medications.
University of Nottingham
Other
Feasibility and Acceptability of a Mindfulness-based Intervention for People With Osteoarthritis (OA) Related Knee Pain.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06400329
Arthritis, Chronic Pain
Hamilton, Ontario, Canada
View Trial DetailsNCT03100539
Arthritis, Chronic Pain
Indianapolis, Indiana, United States
View Trial DetailsNCT05496205
Arthritis, Chronic Pain
Melbourne, Victoria, Australia
View Trial DetailsNCT02456727
Arthritis, Back Pain
The Bronx, New York, United States
View Trial Details