WhiplashNCT03239938
Modern Pain Neuroscience Applied to Chronic Pain in Patients With Chronic Whiplash Associated Disorders
A study testing Modern pain neuroscience approach in people with Whiplash, run by Vrije Universiteit Brussel at 3 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Whiplash
- What is being tested?
- Modern pain neuroscience approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesBelgium
- Study dates
- 17 Aug 2017to 13 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Neuropathic pain
- Being pregnant or having given birth in the preceding year
- Chronic fatigue syndrome
- Fibromyalgia
- Cardiovascular disorders
- Epilepsy
Show all 12Show fewer
- Endocrinological disorders
- Rheumatic disorders
- Psychiatric disorders
- History of neck surgery
- Loss of consciousness during/after the whiplash trauma
- Post-traumatic amnesia
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Sint-jozefkliniek Campus Bornem (AZ Rivierenland)
Bornem, Antwerpen, 2880
Vrije Universiteit Brussel
Brussels, 1000
Ghent University
Ghent, Oost-Vlaanderen, 9000
About this study
Official title: Contemporary Pain Neuroscience Compared to Usual Care Evidence-based Physiotherapy Applied to Chronic Pain in Patients With Chronic Whiplash Associated Disorders: Can we Decrease Central Sensitization?
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.
Read more
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.
Read the detailed description
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: 3 sessions of therapeutic pain neuroscience education followed by 15 sessions of dynamic and functional cognition-targeted exercise therapy and stress management techniques. The main principles of cognition-targeted are the following: All exercises should be performed in a time-contingent ("Perform this exercise 10 times, regardless of the pain") rather than in a symptom-contingent way ("Stop or adjust the exercise when it hurts"). Goal setting is essentially done together with the patient, focussing on functionality. The treating physical therapist should continuously assess and challenge the patients' cognitions and perceptions about the pain and the anticipated outcome of each exercise, to change maladaptive cognitions and perceptions into positive ones.
The primary scientific objective of the study entails examining the effectiveness of a modern pain 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, psychological 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 (n = 60)) or control treatment (usual care evidence-based physiotherapy: 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 functional status. Secondary outcome measures include pain, health-related quality of life, psychological correlates, socio-economic factors, and measures of central sensitization, including electrical detection and electrical pain thresholds measured with a constant current electrical stimulator, endogenous pain facilitation (temporal summation of electrical pain), endogenous pain inhibition assessed by the conditioned pain modulation paradigm (electrical stimulation as test stimulus and the cold pressor test (immersion of one hand in cold water of 12°C) as conditioning stimulus). In addition, quantitative scalp Electroencephalography (EEG) to measure various parameters of brain activation will be performed during the conditioned pain modulation paradigm.
To comply with these scientific objectives, the 120 chronic WAD patients will be subjected to the baseline assessment of all outcome measures.
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 muli-center triple-blind randomized, controlled trial with 1 year follow up will be performed.
Appropriate statistical analyses will be performed to evaluate and compare treatment effects. Statistical, as well as clinical significant differences will be defined and the effect size will be determined. Relations between functional status, pain, psychological correlates and central sensitization will be investigated. Furthermore, prediction of pain and functional status by central sensitization and psychological correlates will be performed in chronic WAD patients. Also, factors associated with clinically important changes in the outcome measures will be unraveled. In addition, factors associated with poor outcome following treatment will be assessed.
- Conditions
- Whiplash
- Being tested
- Modern pain neuroscience approach, Usual care evidence-based physiotherapy
- 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
- Medical subject headings
- Whiplash Injuries, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modern pain neuroscience approachBehavioural
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.
Usual care evidence-based physiotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Modern pain neuroscience approach | Experimental | Modern pain neuroscience approach Receives: Behavioral: Modern pain neuroscience approach |
| Usual care evidence-based physiotherapy | Active comparator | Usual care physiotherapy Receives: Behavioral: Usual care evidence-based physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported functional status or disability
The Dutch version of the Neck Disability Index (questionnaire)
Measured: 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
The Dutch version of the Neck Disability Index (questionnaire)
Measured: 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
The Dutch version of the Short Form Health Survey-36 items (questionnaire)
Measured: 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
A 0-10 Numeric Rating Scale for pain (questionnaire). Patients fill out the Numeric Rating Scale (0 no pain - 10 worst pain imaginable) for their perceived neck pain.
Measured: 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
The Dutch version of the Central Sensitization Inventory (questionnaire)
Measured: 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)
Determination of the electrical detection and electrical pain threshold with the electrical stimulator will be performed at the sural nerve of the dominant leg and at the median nerve of the dominant arm.
Measured: Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy
Endogenous pain facilitation assessed by a temporal summation paradigm
Temporal summation of electrical pain will be assessed by delivering 20 electrical stimuli at the intensity of the electrical pain threshold.
Measured: Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy
Endogenous pain inhibition assessed by a conditioned pain modulation paradigm
Conditioned pain modulation will be tested with electrical stimulation as test stimulus and the cold pressor test (immersion the hand up to the wrist in cold water of 12°C) as conditioning stimulus.
Measured: Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy
Quantitative Electroencephalography (QEEG) (Sienna digital EEG, EMS Biomedical, Korneuburg, Austria) will be recorded from 32 Sn surface electrodes using an electrode cap (Headcap, Expertise in Medical Solutions Biomedical, Korneuburg, Austria).
During the condition pain modulation paradigm a QEEG will be administered to examine various brain activity parameters.
Measured: Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy
Self-reported psychological correlates: Pain catastrophizing
The Dutch version of the Pain Catastrophizing Scale (questionnaire)
Measured: 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 psychological correlates: Illness perceptions
The Dutch version of the illness perception questionnaire-revised (questionnaire)
Measured: 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 psychological correlates: Post-traumatic stress
The Dutch version of the Impact of Event Scale revised (questionnaire)
Measured: 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 psychological correlates: Pain-related fear and fear-avoidance behaviour
The Dutch version of the Pain anxiety symptoms scale (PASS-20) (questionnaire)
Measured: 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.
Socio-economic factors
Self-reported questionnaire and data including health-care expenditure from publicly funded healthcare organizations.
Measured: Baseline assessment, T2 follow-up assessment 6 months after the end of the therapy, T3 follow-up assessment 12 months after the end of the therapy, 1 year before enrollment in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start17 Aug 2017
- Primary completion13 Jun 2022
- Study completion13 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for WhiplashStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent, University Ghent, Research Foundation Flanders, Universitair Ziekenhuis Brussel
- Responsible party
- Principal investigator, Iris Coppieters, Vrije Universiteit Brussel
- Investigators
- Iris Coppieters, PhD, Study director, Vrije Universiteit BrusselJo Nijs, PhD, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239938
- Sponsor's protocol ID
- G007217N
- Status last verified
- Nov 2022
- First submitted
- 1 Aug 2017
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24703832Pinheiro 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.
PubMed 26914356Van 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.
PubMed 23008191Sterling 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.
PubMed 18221907Van 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.
PubMed 21328162Nijs 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.
PubMed 24703833Dolphens 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.
PubMed 24885889Moseley 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.
PubMed 12443524Meeus 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.
PubMed 22996847Nijs 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.
PubMed 25090974Southerst 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.
PubMed 24534390Nijs 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.
PubMed 24481595Nijs 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.
PubMed 21632273Malfliet 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.
PubMed 40794407
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contemporary Pain Neuroscience Compared to Usual Care Evidence-based Physiotherapy Applied to Chronic Pain in Patients With Chronic Whiplash Associated Disorders: Can we Decrease Central Sensitization?
- ClinicalTrials.gov ID
- NCT03239938
- Acronym / sponsor ID
- G007217N
- Conditions
- Whiplash
- Keywords
- chronic whiplash associated disorders, central sensitization, electroencephalography, physiotherapy, chronic pain, functionality, quality of life, stress management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Collaborators
- University Hospital, Ghent, University Ghent, Research Foundation Flanders, Universitair Ziekenhuis Brussel
- Study start
- 17 Aug 2017 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 4 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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: 3 sessions of therapeutic pain neuroscience education followed by 15 sessions of dynamic and functional cognition-targeted exercise therapy and stress management techniques. The main principles of cognition-targeted are the following: All exercises should be performed in a time-contingent ("Perform this exercise 10 times, regardless of the pain") rather than in a symptom-contingent way ("Stop or adjust the exercise when it hurts"). Goal setting is essentially done together with the patient, focussing on functionality. The treating physical therapist should continuously assess and challenge the patients' cognitions and perceptions about the pain and the anticipated outcome of each exercise, to change maladaptive cognitions and perceptions into positive ones.
The primary scientific objective of the study entails examining the effectiveness of a modern pain 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, psychological 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 (n = 60)) or control treatment (usual care evidence-based physiotherapy: 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 functional status. Secondary outcome measures include pain, health-related quality of life, psychological correlates, socio-economic factors, and measures of central sensitization, including electrical detection and electrical pain thresholds measured with a constant current electrical stimulator, endogenous pain facilitation (temporal summation of electrical pain), endogenous pain inhibition assessed by the conditioned pain modulation paradigm (electrical stimulation as test stimulus and the cold pressor test (immersion of one hand in cold water of 12°C) as conditioning stimulus). In addition, quantitative scalp Electroencephalography (EEG) to measure various parameters of brain activation will be performed during the conditioned pain modulation paradigm.
To comply with these scientific objectives, the 120 chronic WAD patients will be subjected to the baseline assessment of all outcome measures.
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 muli-center triple-blind randomized, controlled trial with 1 year follow up will be performed.
Appropriate statistical analyses will be performed to evaluate and compare treatment effects. Statistical, as well as clinical significant differences will be defined and the effect size will be determined. Relations between functional status, pain, psychological correlates and central sensitization will be investigated. Furthermore, prediction of pain and functional status by central sensitization and psychological correlates will be performed in chronic WAD patients. Also, factors associated with clinically important changes in the outcome measures will be unraveled. In addition, factors associated with poor outcome following treatment will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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)).
| Arm | Type | Receives |
|---|---|---|
| Modern pain neuroscience approach | Experimental | Behavioral: Modern pain neuroscience approachModern pain neuroscience approach |
| Usual care evidence-based physiotherapy | Active comparator | Behavioral: Usual care evidence-based physiotherapyUsual care physiotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- Neuropathic pain
- Being pregnant or having given birth in the preceding year
- Chronic fatigue syndrome
- Fibromyalgia
- Cardiovascular disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modern pain neuroscience approachThe 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. | Behavioural | Modern pain neuroscience approach |
| Usual care evidence-based physiotherapyThe 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. | Behavioural | Usual care evidence-based physiotherapy |
Primary outcome
Self-reported functional status or disability
Time frame: The change between the baseline assessment and the 6 months follow-up assessment (6 months after the end of the therapy)
The Dutch version of the Neck Disability Index (questionnaire)
13 secondary outcomes
Self-reported functional status or disability
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy
Endogenous pain facilitation assessed by a temporal summation paradigm
Time frame: Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy
Endogenous pain inhibition assessed by a conditioned pain modulation paradigm
Time frame: Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy
Quantitative Electroencephalography (QEEG) (Sienna digital EEG, EMS Biomedical, Korneuburg, Austria) will be recorded from 32 Sn surface electrodes using an electrode cap (Headcap, Expertise in Medical Solutions Biomedical, Korneuburg, Austria).
Time frame: Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy
Self-reported psychological correlates: Pain catastrophizing
Time frame: 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 psychological correlates: Illness perceptions
Time frame: 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 psychological correlates: Post-traumatic stress
Time frame: 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 psychological correlates: Pain-related fear and fear-avoidance behaviour
Time frame: 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.
Socio-economic factors
Time frame: Baseline assessment, T2 follow-up assessment 6 months after the end of the therapy, T3 follow-up assessment 12 months after the end of the therapy, 1 year before enrollment in the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
- Background: PubMed 24703832Michaleff 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.
- Background: PubMed 26914356Pinheiro 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.
- Background: PubMed 23008191Van 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.
- Background: PubMed 18221907Sterling 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.
- Background: PubMed 21328162Van 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.
- Background: PubMed 24703833Nijs 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.
- Background: PubMed 24885889Dolphens 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.
- Background: PubMed 12443524Moseley 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.
- Background: PubMed 22996847Meeus 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.
- Background: PubMed 25090974Nijs 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.
- Background: PubMed 24534390Southerst 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.
- Background: PubMed 24481595Nijs 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iris Coppieters, PhD study director
Vrije Universiteit Brussel
Jo Nijs, PhD principal investigator
Vrije Universiteit Brussel
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modern pain neuroscience approach in people with Whiplash, run by Vrije Universiteit Brussel at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported functional status or disability (time frame: The change between the baseline assessment and the 6 months follow-up assessment (6 months after the end of the therapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03239938, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2022.