Neuroscience Education on Osteoarthritis

NCT02246088 | Unknown DMC

• 1 other identifier: EDUART13
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis (OA) is a frequent chronic musculoskeletal pathology that usually causes great disability and significant healthcare costs. Substantial scientific evidence indicates a role for central sensitization in OA pain. Reconceptualization of pain through Neuroscience Education (NE) is an intervention that has already been used successfully in some chronic musculoskeletal pain conditions characterized by alteration on CNS pain processing or central sensitization (i.e. chronic low back pain, chronic fatigue syndrome, widespread pain and chronic whiplash associate disorders).There is compelling evidence that NE have a positive effect on pain, disability, catastrophization and physical performance for chronic musculoskeletal pain disorders, yet studies examining the value of NE for OA patients are essentially lacking. The primary aim of this study is to assess the effect of NE on pain, disability and physical performance in subjects with chronic OA knee pain waiting for replacement surgery. This will be the first time NE will be addressed specifically to OA pain. To investigate the benefits of NE on pain related to knee OA, the effect of a manual therapy intervention combined with NE (MT+NE) will be compared with this same manual intervention plus an educational program based on a traditional patho-anatomical or biomedical model (MT+E). The following secondary aims will be addressed as well:

• Examining the effects of the two interventions on the mechanism of central sensitization in patients with knee OA;
• Examining the effects of the two interventions on pain catastrophizing, illness perceptions and kinesiophobia in patients with knee OA;
• Finally, it is aimed at identifying effect moderators for NE in patients with knee OA.

Conditions

Osteoarthritis

Keywords

Osteoarthritis, Central Nervous System Sensitization

Outcome Measures

Primary Outcomes (1)

• Endogenous analgesia through the experimental protocol of conditioned pain modulation

  For assessing endogenous analgesia, the method examining the influence of the Diffuse Noxious Inhibitory Control system (or spatial summation) on temporal summation will be applied. Recently, the term conditioned pain modulation has been recommended to describe the psychophysical paradigm of Diffuse Noxious Inhibitory Control system in humans

  Up to 3 months

Secondary Outcomes (12)

• Pain at rest and in the last 24 hours

  Up to 3 months

• Pressure Pain Thresholds

  Up to 3 months

• Western Ontario and McMaster osteoarthritis index (WOMAC scale)

  Up to 3 months

• Health-related quality of life using the self-reported Spanish version SF-36 questionnaire

  Up to 3 months

• Tampa Scale of Kinesiophobia (TSK) (Spanish version)

  Up to 3 months

Study Arms (2)

MT + NE

EXPERIMENTAL

A manual therapy (MT) intervention combined with neuroscience education (NE)

Procedure: MT + NE

MT + E

ACTIVE COMPARATOR

Manual therapy (MT) intervention plus an educational program based on a traditional patho-anatomical or biomedical model (E)

Procedure: MT + E

Interventions

MT + NE PROCEDURE

Manual therapy will be applied using mobilization with movement (MWM) techniques. MWM will consist of a sustained manual glide of the tibia (either medial, lateral, anterior, posterior, or rotation) during active knee flexion and extension, depending on which are the limited/painful movements for each patient. The content and pictures of the neuroscience education (NE) will be based on the text "Explicando el dolor" (Spanish version of "Explain Pain").

MT + NE

MT + E PROCEDURE

Program of education based on the traditional biomedical model (i.e. through visualization of several videos related to anatomy, biomechanics and surgical procedure of the knee), plus the same manual treatment as per the MT+NE group

MT + E

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• An established diagnosis of knee OA according to American College of Rheumatology criteria and Kellgreen/Lawrence scale grades.
• To be in a waiting list and scheduled to undergo primary knee arthroplasty.
• To have sufficient Spanish language skills to comprehend all explanations and to complete the assessment tools.

You may not qualify if:

• Previous knee joint replacement surgery of the affected joint or any other lower limb surgery within the past 6 months.
• Stated inability to attend or complete the proposed course of intervention and follow-up schedule.
• Presence of co-morbidities associated with cognitive impairment.
• Co-existing inflammatory, metabolic, neurological or severe medical conditions, defined as a diagnosis in the medical record severe enough that the patient cannot participate fully in the study procedures (i.e. cardiovascular disease).
• Functional illiteracy.

Sponsors & Collaborators

• University of Valencia: lead
• Hospital de la Ribera: collaborator

Study Sites (1)

Hospital Universitario de La Ribera

Alzira, Valencia, 46600, Spain

RECRUITING

Related Publications (28)

• Lluch E, Torres R, Nijs J, Van Oosterwijck J. Evidence for central sensitization in patients with osteoarthritis pain: a systematic literature review. Eur J Pain. 2014 Nov;18(10):1367-75. doi: 10.1002/j.1532-2149.2014.499.x. Epub 2014 Apr 3.

  PMID: 24700605 BACKGROUND

• Lluch Girbes E, Meeus M, Baert I, Nijs J. Balancing "hands-on" with "hands-off" physical therapy interventions for the treatment of central sensitization pain in osteoarthritis. Man Ther. 2015 Apr;20(2):349-52. doi: 10.1016/j.math.2014.07.017. Epub 2014 Aug 14.

  PMID: 25169787 BACKGROUND

• Lluch Girbes E, Nijs J, Torres-Cueco R, Lopez Cubas C. Pain treatment for patients with osteoarthritis and central sensitization. Phys Ther. 2013 Jun;93(6):842-51. doi: 10.2522/ptj.20120253. Epub 2013 Feb 7.

  PMID: 23392185 BACKGROUND

• Staud R. Evidence for shared pain mechanisms in osteoarthritis, low back pain, and fibromyalgia. Curr Rheumatol Rep. 2011 Dec;13(6):513-20. doi: 10.1007/s11926-011-0206-6.

  PMID: 21833699 BACKGROUND

• Mease PJ, Hanna S, Frakes EP, Altman RD. Pain mechanisms in osteoarthritis: understanding the role of central pain and current approaches to its treatment. J Rheumatol. 2011 Aug;38(8):1546-51. doi: 10.3899/jrheum.100759. Epub 2011 Jun 1.

  PMID: 21632678 BACKGROUND

• Lee YC, Nassikas NJ, Clauw DJ. The role of the central nervous system in the generation and maintenance of chronic pain in rheumatoid arthritis, osteoarthritis and fibromyalgia. Arthritis Res Ther. 2011 Apr 28;13(2):211. doi: 10.1186/ar3306.

  PMID: 21542893 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

• 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

• 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

• Murphy SL, Lyden AK, Phillips K, Clauw DJ, Williams DA. Subgroups of older adults with osteoarthritis based upon differing comorbid symptom presentations and potential underlying pain mechanisms. Arthritis Res Ther. 2011 Aug 24;13(4):R135. doi: 10.1186/ar3449.

  PMID: 21864381 BACKGROUND

• Moseley L. Combined physiotherapy and education is efficacious for chronic low back pain. Aust J Physiother. 2002;48(4):297-302. doi: 10.1016/s0004-9514(14)60169-0.

  PMID: 12443524 BACKGROUND

• Moseley L. Unraveling the barriers to reconceptualization of the problem in chronic pain: the actual and perceived ability of patients and health professionals to understand the neurophysiology. J Pain. 2003 May;4(4):184-9. doi: 10.1016/s1526-5900(03)00488-7.

  PMID: 14622702 BACKGROUND

• Moseley GL, Nicholas MK, Hodges PW. A randomized controlled trial of intensive neurophysiology education in chronic low back pain. Clin J Pain. 2004 Sep-Oct;20(5):324-30. doi: 10.1097/00002508-200409000-00007.

  PMID: 15322439 BACKGROUND

• Ryan CG, Gray HG, Newton M, Granat MH. Pain biology education and exercise classes compared to pain biology education alone for individuals with chronic low back pain: a pilot randomised controlled trial. Man Ther. 2010 Aug;15(4):382-7. doi: 10.1016/j.math.2010.03.003. Epub 2010 Mar 31.

  PMID: 20359937 BACKGROUND

• Meeus M, Nijs J, Van Oosterwijck J, Van Alsenoy V, Truijen S. Pain physiology education improves pain beliefs in patients with chronic fatigue syndrome compared with pacing and self-management education: a double-blind randomized controlled trial. Arch Phys Med Rehabil. 2010 Aug;91(8):1153-9. doi: 10.1016/j.apmr.2010.04.020.

  PMID: 20684894 BACKGROUND

• Van Oosterwijck J, Nijs J, Meeus M, Truijen S, Craps J, Van den Keybus N, Paul L. Pain neurophysiology education improves cognitions, pain thresholds, and movement performance in people with chronic whiplash: a pilot study. J Rehabil Res Dev. 2011;48(1):43-58. doi: 10.1682/jrrd.2009.12.0206.

  PMID: 21328162 BACKGROUND

• Clarke CL, Ryan CG, Martin DJ. Pain neurophysiology education for the management of individuals with chronic low back pain: systematic review and meta-analysis. Man Ther. 2011 Dec;16(6):544-9. doi: 10.1016/j.math.2011.05.003. Epub 2011 Jun 25.

  PMID: 21705261 BACKGROUND

• Louw A, Puentedura EL, Mintken P. Use of an abbreviated neuroscience education approach in the treatment of chronic low back pain: a case report. Physiother Theory Pract. 2012 Jan;28(1):50-62. doi: 10.3109/09593985.2011.562602. Epub 2011 Jul 3.

  PMID: 21721995 BACKGROUND

• Nijs J, Van Houdenhove B, Oostendorp RA. Recognition of central sensitization in patients with musculoskeletal pain: Application of pain neurophysiology in manual therapy practice. Man Ther. 2010 Apr;15(2):135-41. doi: 10.1016/j.math.2009.12.001. Epub 2009 Dec 24.

  PMID: 20036180 BACKGROUND

• Nijs J, Paul van Wilgen C, Van Oosterwijck J, van Ittersum M, Meeus M. How to explain central sensitization to patients with 'unexplained' chronic musculoskeletal pain: practice guidelines. Man Ther. 2011 Oct;16(5):413-8. doi: 10.1016/j.math.2011.04.005. Epub 2011 May 31.

  PMID: 21632273 BACKGROUND

• Louw A, Diener I, Butler DS, Puentedura EJ. Preoperative education addressing postoperative pain in total joint arthroplasty: review of content and educational delivery methods. Physiother Theory Pract. 2013 Apr;29(3):175-94. doi: 10.3109/09593985.2012.727527. Epub 2012 Oct 4.

  PMID: 23035767 BACKGROUND

• Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.

  PMID: 22133255 BACKGROUND

• Moss P, Sluka K, Wright A. The initial effects of knee joint mobilization on osteoarthritic hyperalgesia. Man Ther. 2007 May;12(2):109-18. doi: 10.1016/j.math.2006.02.009. Epub 2006 Jun 13.

  PMID: 16777467 BACKGROUND

• Takasaki H, Hall T, Jull G. Immediate and short-term effects of Mulligan's mobilization with movement on knee pain and disability associated with knee osteoarthritis--a prospective case series. Physiother Theory Pract. 2013 Feb;29(2):87-95. doi: 10.3109/09593985.2012.702854. Epub 2012 Jul 30.

  PMID: 22844980 BACKGROUND

• French HP, Brennan A, White B, Cusack T. Manual therapy for osteoarthritis of the hip or knee - a systematic review. Man Ther. 2011 Apr;16(2):109-17. doi: 10.1016/j.math.2010.10.011. Epub 2010 Dec 13.

  PMID: 21146444 BACKGROUND

• Jansen MJ, Viechtbauer W, Lenssen AF, Hendriks EJ, de Bie RA. Strength training alone, exercise therapy alone, and exercise therapy with passive manual mobilisation each reduce pain and disability in people with knee osteoarthritis: a systematic review. J Physiother. 2011;57(1):11-20. doi: 10.1016/S1836-9553(11)70002-9.

  PMID: 21402325 BACKGROUND

• Deyle GD, Gill NW, Allison SC, Hando BR, Rochino DA. Knee OA: which patients are unlikely to benefit from manual PT and exercise? J Fam Pract. 2012 Jan;61(1):E1-8.

  PMID: 22220299 BACKGROUND

• Huysmans E, Baeyens JP, Duenas L, Falla D, Meeus M, Roose E, Nijs J, Lluch Girbes E. Do Sex and Pain Characteristics Influence the Effectiveness of Pain Neuroscience Education in People Scheduled for Total Knee Arthroplasty? Secondary Analysis of a Randomized Controlled Trial. Phys Ther. 2021 Dec 1;101(12):pzab197. doi: 10.1093/ptj/pzab197.

  PMID: 34459493 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

NADH dehydrogenase subunit 4

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Enrique Lluch, PT

  University of Valencia

  PRINCIPAL INVESTIGATOR

• Luis Aguilella, PhD

  Hospital Universitario de la Ribera, Alcira (Valencia)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Aguilella, PhD

CONTACT

+34962458100; luis.aguilella@comv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 22, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 22, 2014

Record last verified: 2014-09

Locations

ES (1)