Study Results
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Basic Information
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UNKNOWN
NA
53 participants
INTERVENTIONAL
2013-12-31
2015-12-31
Brief Summary
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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.
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Detailed Description
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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). Moreover, some clinical guides to help clinicians to identify and explain central sensitization through NE, have been recently published. However, this kind of intervention has never been tested specifically for chronic pain related to OA.
Preoperative education centered on a biomedical model of anatomy and pathoanatomy as well as procedural information has limited effect in reducing postoperative pain after total hip arthroplasty and total hip arthroplasty surgeries. Preoperative educational sessions that aim to increase patient knowledge of pain science (i.e. NE) may be more effective in managing postoperative pain. NE is a cognitive-based educational intervention that aims to reduce pain and disability by helping patients gain an increased understanding of the biological processes underpinning their pain state. 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.
Joint mobilization has been shown to be a useful modality to reduce pain related to osteoarthritis. Regarding the knee joint, two recent systematic reviews demonstrated the usefulness of manual therapy and exercise for the management of knee OA. Moreover, Deyle et al reported a preliminary clinical prediction rule which may help to identify the minority of knee OA patients who are unlikely to respond to this management approach.
The primary aim of this study is therefore 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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MT + NE
A manual therapy (MT) intervention combined with neuroscience education (NE)
MT + NE
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 + E
Manual therapy (MT) intervention plus an educational program based on a traditional patho-anatomical or biomedical model (E)
MT + E
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
Interventions
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MT + NE
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 + E
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
Eligibility Criteria
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Inclusion Criteria
2. To be in a waiting list and scheduled to undergo primary knee arthroplasty.
3. To have sufficient Spanish language skills to comprehend all explanations and to complete the assessment tools.
Exclusion Criteria
2. Stated inability to attend or complete the proposed course of intervention and follow-up schedule.
3. Presence of co-morbidities associated with cognitive impairment.
4. 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).
5. Functional illiteracy.
ALL
No
Sponsors
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Hospital de la Ribera
OTHER
University of Valencia
OTHER
Responsible Party
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Enrique Lluch Girbés
Physiotherapist
Principal Investigators
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Enrique Lluch, PT
Role: PRINCIPAL_INVESTIGATOR
University of Valencia
Luis Aguilella, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario de la Ribera, Alcira (Valencia)
Locations
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Hospital Universitario de La Ribera
Alzira, Valencia, Spain
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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EDUART13
Identifier Type: -
Identifier Source: org_study_id
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