Pain Sensitization and Outcome Following Physiotherapy in Patients With Knee Osteoarthritis

NCT02310945 | Unknown

• 1 other identifier: HPF/2013/44
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 3

Brief Summary

Pain is the dominant symptom of knee osteoarthritis and recent evidence suggests factors outside of local joint pathology, such as pain sensitization, can contribute significantly to the pain experience. It is unknown how pain sensitization influences outcomes from commonly employed interventions such as physiotherapy. The aims of this study are, firstly to identify people with knee OA who display signs and symptoms associated with pain sensitization using clinical tools and quantitative sensory testing. Secondly, we will investigate if indications of pain sensitization at baseline are associated with poor outcome following physiotherapy. Methods and analysis: This is a multi-centre prospective cohort study with 140 participants. Eligible patients with moderate/severe symptomatic knee osteoarthritis will be identified at hospital outpatient clinics. A baseline assessment will provide a comprehensive description of the somatosensory characteristics of each participant by means of clinical examination, quantitative sensory testing and validated questionnaires measuring pain and functional capacity. Participants will then undergo physiotherapy treatment, in line with current clinical guidelines. Follow-up post physiotherapy treatment (estimated to be at 3 months) will assess pain, disability (sub-scales of Western Ontario and McMasters University Score Osteoarthritis Index) and participants' global rating of change. These primary outcome measures will dichotomise participants into treatment 'responders' and 'non-responders' according to the Osteoarthritis Research Society International (OARSI) treatment responder criteria. For data analysis results from pressure pain thresholds, temporal summation and conditioned pain modulation will create a composite score of pain sensitization. Logistic regression will explore the relationship between response to physiotherapy and pain sensitization at baseline while accounting for various cofounders.

Conditions

Knee Osteoarthritis

Keywords

pain; central nervous system sensitization; physiotherapy

Outcome Measures

Primary Outcomes (1)

• Change in response to physiotherapy as measured by the pain and function sub-scales of Western Ontario and McMasters University Score Osteoarthritis Index (WOMAC) and patient's global rating of change.

  These 3 outcome measures will gather data that will be applied to a set of treatment responder criteria by the Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) to determine a positive response to physiotherapy or a 'treatment responder'

  Baseline & at 3 months (estimated time point for physiotherapy treatment completion)

Secondary Outcomes (12)

• Quantitative sensory testing (pressure pain thresholds, temporal summation, conditioned pain modulation, mechanical detection thresholds)

  Baseline

• Central Sensitization Inventory

  Baseline

• Modified PainDETECT

  Baseline

• Centre for Epidemiologic Studies Depression Scale (CES-D)

  Baseline

• Overweight/Obesity

  Baseline

Study Arms (1)

Knee osteoarthritis

People with moderate/severe symptomatic knee osteoarthritis referred for physiotherapy

Other: Physiotherapy

Interventions

Physiotherapy OTHER

Individualised programme for each patient in line with current clinical guidelines. May include education, exercise (strengthening, range of motion exercise, aerobic), lifestyle advice and manual therapy

Knee osteoarthritis

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The cohort will be recruited from patients with moderate/severe symptomatic knee OA attending outpatient orthopaedic and rheumatology clinics and referred for physiotherapy treatment by a hospital consultant or clinical specialist physiotherapist. At the time of recruitment knee pain must be the participant's primary musculoskeletal complaint they are seeking treatment for, and physiotherapy must be the main treatment being undertaken over the study period

You may qualify if:

• Knee osteoarthritis diagnosed by American College of Rheumatology clinical criteria
• Knee pain must be the primary musculoskeletal complaint participant is seeking treatment for
• Pain duration greater than 3 months
• Pain severity ≥ 5/10 on Numerical Rating Scale
• Willing to abstain from simple analgesics and NSAIDs for 24 hours prior to testing
• Willing and able to give full consent

You may not qualify if:

• Lumbar or cervical radiculopathy,
• Systematic inflammatory disease,
• Positive screen for diabetic neuropathy
• Past medical history
• Previous surgery or disease of the peripheral or central nervous system,
• Sensory loss secondary to chemotherapy or radiotherapy
• Fibromyalgia
• Chronic fatigue syndrome
• Cognitive or psychiatric disorder interfering with ability to cooperate with assessment
• Injection or physiotherapy treatment for knee joint within previous 3 months
• Taking anti-depressant or anti-convulsant medication

Sponsors & Collaborators

• University College Dublin: lead
• Health Research Board, Ireland: collaborator

Study Sites (3)

St. James's Hospital

Dublin, Dublin, 2, Ireland

RECRUITING

St. Vincent's University Hospital

Dublin, Dublin, 4, Ireland

RECRUITING

Tallaght Hospital

Dublin, Dublin, Ireland

RECRUITING

Related Publications (20)

• Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.

  PMID: 20699159 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

• Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-S15. doi: 10.1016/j.pain.2010.09.030. Epub 2010 Oct 18.

  PMID: 20961685 BACKGROUND

• Imamura M, Imamura ST, Kaziyama HH, Targino RA, Hsing WT, de Souza LP, Cutait MM, Fregni F, Camanho GL. Impact of nervous system hyperalgesia on pain, disability, and quality of life in patients with knee osteoarthritis: a controlled analysis. Arthritis Rheum. 2008 Oct 15;59(10):1424-31. doi: 10.1002/art.24120.

  PMID: 18821657 BACKGROUND

• Arendt-Nielsen L, Nie H, Laursen MB, Laursen BS, Madeleine P, Simonsen OH, Graven-Nielsen T. Sensitization in patients with painful knee osteoarthritis. Pain. 2010 Jun;149(3):573-581. doi: 10.1016/j.pain.2010.04.003. Epub 2010 Apr 24.

  PMID: 20418016 BACKGROUND

• Gwilym SE, Oag HC, Tracey I, Carr AJ. Evidence that central sensitisation is present in patients with shoulder impingement syndrome and influences the outcome after surgery. J Bone Joint Surg Br. 2011 Apr;93(4):498-502. doi: 10.1302/0301-620X.93B4.25054.

  PMID: 21464489 BACKGROUND

• Coombes BK, Bisset L, Vicenzino B. Cold hyperalgesia associated with poorer prognosis in lateral epicondylalgia: a 1-year prognostic study of physical and psychological factors. Clin J Pain. 2015 Jan;31(1):30-5. doi: 10.1097/AJP.0000000000000078.

  PMID: 24480912 BACKGROUND

• Wylde V, Palmer S, Learmonth ID, Dieppe P. The association between pre-operative pain sensitisation and chronic pain after knee replacement: an exploratory study. Osteoarthritis Cartilage. 2013 Sep;21(9):1253-6. doi: 10.1016/j.joca.2013.05.008.

  PMID: 23973138 BACKGROUND

• McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.

  PMID: 24462672 BACKGROUND

• Peters TJ, Sanders C, Dieppe P, Donovan J. Factors associated with change in pain and disability over time: a community-based prospective observational study of hip and knee osteoarthritis. Br J Gen Pract. 2005 Mar;55(512):205-11.

  PMID: 15808036 BACKGROUND

• Sterling M, Jull G, Vicenzino B, Kenardy J. Sensory hypersensitivity occurs soon after whiplash injury and is associated with poor recovery. Pain. 2003 Aug;104(3):509-517. doi: 10.1016/S0304-3959(03)00078-2.

  PMID: 12927623 BACKGROUND

• Smart KM, Blake C, Staines A, Thacker M, Doody C. Mechanisms-based classifications of musculoskeletal pain: part 1 of 3: symptoms and signs of central sensitisation in patients with low back (+/- leg) pain. Man Ther. 2012 Aug;17(4):336-44. doi: 10.1016/j.math.2012.03.013. Epub 2012 Apr 23.

  PMID: 22534654 BACKGROUND

• Yarnitsky D, Granot M, Granovsky Y. Pain modulation profile and pain therapy: between pro- and antinociception. Pain. 2014 Apr;155(4):663-665. doi: 10.1016/j.pain.2013.11.005. Epub 2013 Nov 21. No abstract available.

  PMID: 24269491 BACKGROUND

• O'Neill S, Manniche C, Graven-Nielsen T, Arendt-Nielsen L. Association between a composite score of pain sensitivity and clinical parameters in low-back pain. Clin J Pain. 2014 Oct;30(10):831-8. doi: 10.1097/AJP.0000000000000042.

  PMID: 24121529 BACKGROUND

• Wylde V, Palmer S, Learmonth ID, Dieppe P. Somatosensory abnormalities in knee OA. Rheumatology (Oxford). 2012 Mar;51(3):535-43. doi: 10.1093/rheumatology/ker343. Epub 2011 Nov 24.

  PMID: 22120461 BACKGROUND

• Graven-Nielsen T, Wodehouse T, Langford RM, Arendt-Nielsen L, Kidd BL. Normalization of widespread hyperesthesia and facilitated spatial summation of deep-tissue pain in knee osteoarthritis patients after knee replacement. Arthritis Rheum. 2012 Sep;64(9):2907-16. doi: 10.1002/art.34466.

  PMID: 22421811 BACKGROUND

• Cruz-Almeida Y, Fillingim RB. Can quantitative sensory testing move us closer to mechanism-based pain management? Pain Med. 2014 Jan;15(1):61-72. doi: 10.1111/pme.12230. Epub 2013 Sep 6.

  PMID: 24010588 BACKGROUND

• Yunus MB. Central sensitivity syndromes: a new paradigm and group nosology for fibromyalgia and overlapping conditions, and the related issue of disease versus illness. Semin Arthritis Rheum. 2008 Jun;37(6):339-52. doi: 10.1016/j.semarthrit.2007.09.003. Epub 2008 Jan 14.

  PMID: 18191990 BACKGROUND

• Staud R. Abnormal endogenous pain modulation is a shared characteristic of many chronic pain conditions. Expert Rev Neurother. 2012 May;12(5):577-85. doi: 10.1586/ern.12.41.

  PMID: 22550986 BACKGROUND

• O'Leary H, Smart KM, Moloney NA, Blake C, Doody CM. Pain sensitisation and the risk of poor outcome following physiotherapy for patients with moderate to severe knee osteoarthritis: protocol for a prospective cohort study. BMJ Open. 2015 Jun 9;5(6):e007430. doi: 10.1136/bmjopen-2014-007430.

  PMID: 26059523 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Helen O'Leary, BSc Physio

  University College Dublin

  PRINCIPAL INVESTIGATOR

• Catherine Doody, BSc Physio

  University College Dublin

  STUDY DIRECTOR

• Keith Smart, BSc Physio

  St Vincent's University Hospital, Ireland

  STUDY CHAIR

• Niamh Moloney, BSc Physio

  University College Dublin

  STUDY CHAIR

Central Study Contacts

Helen O'Leary, BSc Physio

CONTACT

353860665530; helen.oleary@ucdconnect.ie

Catherine Doody, BSc Physio

CONTACT

00353 17166514; c.doody@ucd.ie

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2014
• First Posted: December 8, 2014
• Study Start: June 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: January 1, 2016
• Last Updated: December 8, 2014

Record last verified: 2014-12

Locations

IE (3)