- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02246088
Neuroscience Education on Osteoarthritis
Effect of Neuroscience Education on Subjects With Chronic Knee Pain Related to Osteoarthritis : a Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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. Pathophysiological mechanisms underlying central sensitisation are complex and numerous, but the net effect is an amplification of neural signaling within the CNS than elicits pain hypersensitivity. Central sensitization management is an area of great interest at least in a subgroup of patients with 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). 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Valencia
-
Alcira, Valencia, Spain, 46600
- Recruiting
- Hospital Universitario de La Ribera
-
Principal Investigator:
- Enrique Lluch, PT
-
Principal Investigator:
- Luis Aguilella, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MT + NE
A manual therapy (MT) intervention combined with neuroscience education (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"). |
Active Comparator: MT + E
Manual therapy (MT) intervention plus an educational program based on a traditional patho-anatomical or biomedical model (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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endogenous analgesia through the experimental protocol of conditioned pain modulation
Time Frame: Up to 3 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain at rest and in the last 24 hours
Time Frame: Up to 3 months
|
Participants will be asked to rate their pain at rest and in the last 24 hours on a horizontal 100-mm visual analogue scale (VAS).
The horizontal line anchors will be "no pain" and "worst imaginable pain".
The VAS is a valid and reliable instrument compared with other pain rating scales and has been well established in clinical practice and research for measuring pain levels in arthritis populations.
|
Up to 3 months
|
Pressure Pain Thresholds
Time Frame: Up to 3 months
|
Local and distant sites will be chosen for pressure pain threshold measurement.
Regarding local sites, two points will be measured from the knee, 3 cm medial and lateral to the midpoint of the medial and lateral edge of patella, respectively.
Regarding control site, a distant site will be used to assess systematic analgesic effect of NE at 5 cm distal to lateral epicondyle.
|
Up to 3 months
|
Western Ontario and McMaster osteoarthritis index (WOMAC scale)
Time Frame: Up to 3 months
|
WOMAC assesses pain, stiffness and physical function and can be completed in less than 5 minutes.
It's a widely used, reliable, valid and responsive measure of outcome in people with osteoarthritis of the hip or knee.
|
Up to 3 months
|
Health-related quality of life using the self-reported Spanish version SF-36 questionnaire
Time Frame: Up to 3 months
|
Up to 3 months
|
|
Tampa Scale of Kinesiophobia (TSK) (Spanish version)
Time Frame: Up to 3 months
|
Up to 3 months
|
|
Pain Catastrophization Scale (PCS) (Spanish version)
Time Frame: Up to 3 months
|
Up to 3 months
|
|
Chronic Pain Coping Inventory-42 (Spanish version)
Time Frame: Up to 3 months
|
Up to 3 months
|
|
Chronic Pain Acceptance Questionnaire (Spanish version)
Time Frame: Up to 3 months
|
Up to 3 months
|
|
Goniometric assessment of knee flexion and extension range of motion
Time Frame: Up to 3 months
|
Up to 3 months
|
|
Strength of the hamstrings and quadriceps muscles
Time Frame: Up to 3 months
|
Up to 3 months
|
|
Timed "Up & Go" (TUG) Test
Time Frame: Up to 3 months
|
Participants will be required to rise from a standard arm chair, walk at a safe and comfortable pace to a mark 3 m away and then return to a sitting position in the chair.
The outcome of the test will be the time to complete the task.
Time will be measured on a stopwatch to the nearest one-hundredth of a second.
|
Up to 3 months
|
Central Sensitization Inventory
Time Frame: Up to 3 months
|
Signs and symptoms suggesting central sensitization will be monitorized using the Central Sensitization Inventory
|
Up to 3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Enrique Lluch, PT, University of Valencia
- Principal Investigator: Luis Aguilella, PhD, Hospital Universitario de la Ribera, Alcira (Valencia)
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. 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.
- 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.
- 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.
- 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.
- 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 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EDUART13
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