Mindfulness for Osteoarthritis-related Knee Pain

NCT02595099 | Completed

• 1 other identifier: 15098
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Acceptability

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

  8 weeks

Secondary Outcomes (10)

• WOMAC Index

  8 weeks, 6 months

• Neuropathic Pain

  8 weeks, 6 months

• self-efficacy

  8 weeks, 6 months

• Pain Attitudes

  8 weeks, 6 months

• Pain Catastrophising

  8 weeks, 6 months

Study Arms (1)

Mindfulness training

EXPERIMENTAL

8 week programme of Mindfulness training

Other: Mindfulness training

Interventions

Mindfulness training OTHER

group-based training programme, 2.5 hours delivered weekly for 8 weeks

Mindfulness training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead
• Nottingham University Hospitals NHS Trust: collaborator

Related Publications (13)

• 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.

  PMID: 21265650 BACKGROUND

• 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. No abstract available.

  PMID: 25406303 BACKGROUND

• Zangi HA, Mowinckel P, Finset A, Eriksson LR, Hoystad TO, 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.

  PMID: 22186709 BACKGROUND

• Schutze 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.

  PMID: 25136324 BACKGROUND

• 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.

  PMID: 26009534 BACKGROUND

• 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.

  PMID: 21954151 BACKGROUND

• 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.

  PMID: 22961435 BACKGROUND

• 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.

  PMID: 22550055 BACKGROUND

• 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.

  PMID: 20662042 BACKGROUND

• 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.

  PMID: 22034116 BACKGROUND

• Wylde V, Hewlett S, Learmonth ID, Dieppe P. Persistent pain after joint replacement: prevalence, sensory qualities, and postoperative determinants. Pain. 2011 Mar;152(3):566-572. doi: 10.1016/j.pain.2010.11.023. Epub 2011 Jan 15.

  PMID: 21239114 BACKGROUND

• 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. doi: 10.2106/00004623-199802000-00003.

  PMID: 9486722 BACKGROUND

• 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.

  PMID: 20170770 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Chronic Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michelle Hall

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2015
• First Posted: November 3, 2015
• Study Start: May 20, 2016
• Primary Completion: September 6, 2016
• Study Completion: December 30, 2016
• Last Updated: January 31, 2019

Record last verified: 2015-05