Modern Pain Neuroscience Applied to Chronic Pain in Patients With Chronic Whiplash Associated Disorders

NCT03239938 | Completed

• 1 other identifier: G007217N
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

Modern pain neuroscience has advanced our understanding of chronic whiplash associated disorders (WAD). Previous studies have shown the importance of central sensitization, characterized by hypersensitivity of the somatosensory system, in explaining poor treatment outcome. Therefore, and to address the need for a better treatment of chronic WAD, we recently proposed a modern neuroscience approach to chronic WAD. Such approach includes two specific parts: therapeutic pain neuroscience education followed by dynamic and functional cognition-targeted exercise therapy and stress management techniques. The primary scientific objective of the study entails examining the effectiveness of a modern neuroscience approach versus usual care evidence-based physiotherapy for reducing dysfunctioning in patients with chronic WAD. The secondary scientific objective of the study entails examining the effectiveness of a modern neuroscience approach versus usual care evidence-based physiotherapy for reducing pain, central sensitization, psychosocial problems, and socio-economic burden in patients with chronic WAD. The trial will randomize 120 patients with chronic WAD, aged between 18 and 65 years, to the experimental (modern pain neuroscience approach including 3 sessions of therapeutic pain neuroscience education followed by 15 sessions of dynamic and functional cognition-targeted exercise therapy and stress management techniques (n = 60)) or the control treatment (usual care physiotherapy including 3 sessions of neck school followed by 15 sessions of graded and active exercise therapy focusing on strength, flexibility, endurance, and ergonomic principles (n= 60)). The primary outcome measure is self-reported functional status. Secondary outcome measures include pain, health-related quality of life, psychological correlates, measures of central sensitization, and socio-economic factors. In addition, quantitative scalp Electroencephalography (EEG) to measure various parameters of brain activation will be performed during a conditioned pain modulation paradigm. Baseline assessment of all outcome measures will be performed. Follow-up assessments will be performed immediately after 16 weeks of therapy (all tests), and 6 months (all tests) and 12 months (only questionnaires) after finishing the therapeutic intervention. To investigate these objectives, a multi-center triple-blind randomized, controlled trial with 1 year follow up will be performed.

Conditions

Whiplash

Keywords

chronic whiplash associated disorders; central sensitization; electroencephalography; physiotherapy; chronic pain; functionality; quality of life; stress management; randomized controlled trial; modern neuroscience approach; pain neuroscience education; neck school; exercise therapy; pain cognitions

Outcome Measures

Primary Outcomes (1)

• Self-reported functional status or disability

  The Dutch version of the Neck Disability Index (questionnaire)

  The change between the baseline assessment and the 6 months follow-up assessment (6 months after the end of the therapy)

Secondary Outcomes (13)

• Self-reported functional status or disability

  Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T3 follow-up assessment 12 months after the end of the therapy.

• Self-reported health-related quality of life

  Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy, T3 assessment 12 months after the end of the therapy.

• Self-reported pain assessment

  Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy, T3 follow-up assessment 12 months after the end of the therapy.

• Self-reported central sensitization symptoms

  Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy, T3 follow-up assessment 12 months after the end of the therapy.

• Electrical detection and electrical pain thresholds with a constant current electrical stimulator (DS7A Digitimer)

  Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy

Study Arms (2)

Modern pain neuroscience approach

EXPERIMENTAL

Modern pain neuroscience approach

Behavioral: Modern pain neuroscience approach

Usual care evidence-based physiotherapy

ACTIVE COMPARATOR

Usual care physiotherapy

Behavioral: Usual care evidence-based physiotherapy

Interventions

Modern pain neuroscience approach BEHAVIORAL

The modern pain neuroscience approach includes 3 sessions (1 group and 2 individual sessions) of therapeutic pain neuroscience education followed by 15 individual sessions of dynamic and functional cognition-targeted exercise therapy and stress management techniques. In addition, participants will be instructed to perform a daily set of home exercises. The exercises will be performed in a time-contingent way. The 18 sessions will be spread over a period of 16 weeks.

Modern pain neuroscience approach

Usual care evidence-based physiotherapy BEHAVIORAL

The usual care evidence-based physiotherapy includes 3 sessions (1 group and 2 individual sessions) of neck school followed by 15 individual sessions of graded and active exercise therapy focusing on strength, flexibility, endurance, and ergonomic principles. In addition, participants will be instructed to perform a daily set of home exercises. The exercises will be performed in a symptom-contingent way. The 18 sessions will be spread over a period of 16 weeks.

Usual care evidence-based physiotherapy

Eligibility Criteria

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

You may qualify if:

• Experienced a whiplash trauma which is at least 3 months old and causes pain since at least 3 months, with pain experience with a mean pain frequency of 3 or more days per week, and with self-reported moderate to severe pain-related disability, established by a score of 15 or more of a maximum of 50 on the Neck Disability Index
• Patients classified as WAD II or WAD III on the modified Quebec Task Force Scale
• Native Dutch speaker
• Not starting new treatments or medication and continuing their usual care 6 weeks prior to and during study participation (to obtain a steady state)
• Refraining from non-opioid analgesics in the previous 48h of the assessments
• Refraining from caffeine, alcohol, and nicotine in the previous 24h of the assessments

You may not qualify if:

• Neuropathic pain
• Being pregnant or having given birth in the preceding year
• Chronic fatigue syndrome
• Fibromyalgia
• Cardiovascular disorders
• Epilepsy
• Endocrinological disorders
• Rheumatic disorders
• Psychiatric disorders
• History of neck surgery
• Loss of consciousness during/after the whiplash trauma
• Post-traumatic amnesia

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• University Hospital, Ghent: collaborator
• University Ghent: collaborator
• Research Foundation Flanders: collaborator
• Universitair Ziekenhuis Brussel: collaborator

Study Sites (3)

Sint-jozefkliniek Campus Bornem (AZ Rivierenland)

Bornem, Antwerpen, 2880, Belgium

Location

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Vrije Universiteit Brussel

Brussels, 1000, Belgium

Location

Related Publications (14)

• Michaleff ZA, Maher CG, Lin CW, Rebbeck T, Jull G, Latimer J, Connelly L, Sterling M. Comprehensive physiotherapy exercise programme or advice for chronic whiplash (PROMISE): a pragmatic randomised controlled trial. Lancet. 2014 Jul 12;384(9938):133-41. doi: 10.1016/S0140-6736(14)60457-8. Epub 2014 Apr 4.

  PMID: 24703832 BACKGROUND

• Pinheiro ES, de Queiros FC, Montoya P, Santos CL, do Nascimento MA, Ito CH, Silva M, Nunes Santos DB, Benevides S, Miranda JG, Sa KN, Baptista AF. Electroencephalographic Patterns in Chronic Pain: A Systematic Review of the Literature. PLoS One. 2016 Feb 25;11(2):e0149085. doi: 10.1371/journal.pone.0149085. eCollection 2016.

  PMID: 26914356 BACKGROUND

• Van Oosterwijck J, Nijs J, Meeus M, Paul L. Evidence for central sensitization in chronic whiplash: a systematic literature review. Eur J Pain. 2013 Mar;17(3):299-312. doi: 10.1002/j.1532-2149.2012.00193.x. Epub 2012 Sep 25.

  PMID: 23008191 BACKGROUND

• Sterling M, Kenardy J. Physical and psychological aspects of whiplash: Important considerations for primary care assessment. Man Ther. 2008 May;13(2):93-102. doi: 10.1016/j.math.2007.11.003. Epub 2008 Jan 24.

  PMID: 18221907 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

• Nijs J, Ickmans K. Chronic whiplash-associated disorders: to exercise or not? Lancet. 2014 Jul 12;384(9938):109-11. doi: 10.1016/S0140-6736(14)60130-6. Epub 2014 Apr 4. No abstract available.

  PMID: 24703833 BACKGROUND

• Dolphens M, Nijs J, Cagnie B, Meeus M, Roussel N, Kregel J, Malfliet A, Vanderstraeten G, Danneels L. Efficacy of a modern neuroscience approach versus usual care evidence-based physiotherapy on pain, disability and brain characteristics in chronic spinal pain patients: protocol of a randomized clinical trial. BMC Musculoskelet Disord. 2014 May 8;15:149. doi: 10.1186/1471-2474-15-149.

  PMID: 24885889 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

• Meeus M, Nijs J, Hamers V, Ickmans K, Oosterwijck JV. The efficacy of patient education in whiplash associated disorders: a systematic review. Pain Physician. 2012 Sep-Oct;15(5):351-61.

  PMID: 22996847 BACKGROUND

• Nijs J, Lluch Girbes E, Lundberg M, Malfliet A, Sterling M. Exercise therapy for chronic musculoskeletal pain: Innovation by altering pain memories. Man Ther. 2015 Feb;20(1):216-20. doi: 10.1016/j.math.2014.07.004. Epub 2014 Jul 18.

  PMID: 25090974 BACKGROUND

• Southerst D, Nordin MC, Cote P, Shearer HM, Varatharajan S, Yu H, Wong JJ, Sutton DA, Randhawa KA, van der Velde GM, Mior SA, Carroll LJ, Jacobs CL, Taylor-Vaisey AL. Is exercise effective for the management of neck pain and associated disorders or whiplash-associated disorders? A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration. Spine J. 2016 Dec;16(12):1503-1523. doi: 10.1016/j.spinee.2014.02.014. Epub 2014 Feb 15.

  PMID: 24534390 BACKGROUND

• Nijs J, Meeus M, Cagnie B, Roussel NA, Dolphens M, Van Oosterwijck J, Danneels L. A modern neuroscience approach to chronic spinal pain: combining pain neuroscience education with cognition-targeted motor control training. Phys Ther. 2014 May;94(5):730-8. doi: 10.2522/ptj.20130258. Epub 2014 Jan 30.

  PMID: 24481595 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

• Malfliet A, Lenoir D, Murillo C, Huysmans E, Cagnie B, Meeus M, Willaert W, Ickmans K, Danneels L, Bontinck J, Nijs J, Coppieters I. Pain Science Education, Stress Management, and Cognition-Targeted Exercise Therapy in Chronic Whiplash Disorders: A Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2526674. doi: 10.1001/jamanetworkopen.2025.26674.

  PMID: 40794407 DERIVED

MeSH Terms

Conditions

Whiplash Injuries; Chronic Pain

Condition Hierarchy (Ancestors)

Neck Injuries; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Iris Coppieters, PhD

  Vrije Universiteit Brussel

  STUDY DIRECTOR

• Jo Nijs, PhD

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr. Iris Coppieters (principal investigator)

Model Details: The trial will randomize 120 patients with chronic WAD, aged between 18 and 65 years, to the experimental (modern neuroscience approach including 3 sessions of therapeutic pain neuroscience education followed by 15 sessions of dynamic and functional cognition-targeted exercise therapy and stress management techniques (n = 60)) or the control treatment (usual care physiotherapy: 3 sessions of neck school followed by 15 sessions of exercise therapy focusing on strength, flexibility, endurance, and ergonomic principles (n= 60)).

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 4, 2017
• Study Start: August 17, 2017
• Primary Completion: June 13, 2022
• Study Completion: June 13, 2022
• Last Updated: November 28, 2022

Record last verified: 2022-11

Locations

BE (3)