Mindfulness for Osteoarthritis-related Knee Pain

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02595099
• Other study ID #: 15098
• Status: Completed
• Phase: N/A
• Start date: May 20, 2016
• Est. completion date: December 30, 2016

Study information

• Verified date: May 2015
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 30, 2016
• Est. primary completion date: September 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Osteoarthritis

Intervention

Other:
• Mindfulness training
group-based training programme, 2.5 hours delivered weekly for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	Nottingham University Hospitals NHS Trust

References & Publications (13)

Bawa FL, Mercer SW, Atherton RJ, Clague F, Keen A, Scott NW, Bond CM. Does mindfulness improve outcomes in patients with chronic pain? Systematic review and meta-analysis. Br J Gen Pract. 2015 Jun;65(635):e387-400. doi: 10.3399/bjgp15X685297. Review. — View Citation

Chiesa A, Serretti A. Mindfulness-based interventions for chronic pain: a systematic review of the evidence. J Altern Complement Med. 2011 Jan;17(1):83-93. doi: 10.1089/acm.2009.0546. Review. — View Citation

Finan PH, Buenaver LF, Bounds SC, Hussain S, Park RJ, Haque UJ, Campbell CM, Haythornthwaite JA, Edwards RR, Smith MT. Discordance between pain and radiographic severity in knee osteoarthritis: findings from quantitative sensory testing of central sensitization. Arthritis Rheum. 2013 Feb;65(2):363-72. doi: 10.1002/art.34646. — View Citation

Fogarty FA, Booth RJ, Gamble GD, Dalbeth N, Consedine NS. The effect of mindfulness-based stress reduction on disease activity in people with rheumatoid arthritis: a randomised controlled trial. Ann Rheum Dis. 2015 Feb;74(2):472-4. doi: 10.1136/annrheumdis-2014-205946. Epub 2014 Nov 18. — View Citation

Hawker G, Wright J, Coyte P, Paul J, Dittus R, Croxford R, Katz B, Bombardier C, Heck D, Freund D. Health-related quality of life after knee replacement. J Bone Joint Surg Am. 1998 Feb;80(2):163-73. — View Citation

Hawker GA, Gignac MA, Badley E, Davis AM, French MR, Li Y, Perruccio AV, Power JD, Sale J, Lou W. A longitudinal study to explain the pain-depression link in older adults with osteoarthritis. Arthritis Care Res (Hoboken). 2011 Oct;63(10):1382-90. doi: 10.1002/acr.20298. Epub 2010 Jul 26. — View Citation

Murphy LB, Sacks JJ, Brady TJ, Hootman JM, Chapman DP. Anxiety and depression among US adults with arthritis: prevalence and correlates. Arthritis Care Res (Hoboken). 2012 Jul;64(7):968-76. doi: 10.1002/acr.21685. — View Citation

Murphy SL, Lyden AK, Phillips K, Clauw DJ, Williams DA. Association between pain, radiographic severity, and centrally-mediated symptoms in women with knee osteoarthritis. Arthritis Care Res (Hoboken). 2011 Nov;63(11):1543-9. doi: 10.1002/acr.20583. — View Citation

Schütze R, Slater H, O'Sullivan P, Thornton J, Finlay-Jones A, Rees CS. Mindfulness-Based Functional Therapy: a preliminary open trial of an integrated model of care for people with persistent low back pain. Front Psychol. 2014 Aug 4;5:839. doi: 10.3389/fpsyg.2014.00839. eCollection 2014. — View Citation

Sofat N, Ejindu V, Kiely P. What makes osteoarthritis painful? The evidence for local and central pain processing. Rheumatology (Oxford). 2011 Dec;50(12):2157-65. doi: 10.1093/rheumatology/ker283. Epub 2011 Sep 27. Review. — View Citation

Wylde V, Hewlett S, Learmonth ID, Dieppe P. Persistent pain after joint replacement: prevalence, sensory qualities, and postoperative determinants. Pain. 2011 Mar;152(3):566-72. doi: 10.1016/j.pain.2010.11.023. Epub 2011 Jan 15. — View Citation

Zangi HA, Mowinckel P, Finset A, Eriksson LR, Høystad TØ, Lunde AK, Hagen KB. A mindfulness-based group intervention to reduce psychological distress and fatigue in patients with inflammatory rheumatic joint diseases: a randomised controlled trial. Ann Rheum Dis. 2012 Jun;71(6):911-7. doi: 10.1136/annrheumdis-2011-200351. Epub 2011 Dec 20. — View Citation

Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage. 2010 Apr;18(4):476-99. doi: 10.1016/j.joca.2010.01.013. Epub 2010 Feb 11. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability	This will be determined by the number of participants who completed the intervention and from focus group discussions.	8 weeks
Secondary	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
Secondary	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
Secondary	self-efficacy	The Arthritis self-efficacy scale; a 20 item questionnaire to measure self-efficacy.	8 weeks, 6 months
Secondary	Pain Attitudes	The Survey of Pain Attitudes; a 30 item questionnaire assessing patients attitudes and beliefs about their pain.	8 weeks, 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	health service use	Service use questionnaire; a 10 item questionnaire to measure health and social care service use including medications.	8 weeks, 6 months