Clinical trial NCT01544075: Efficacy of Pain Neurophysiology Education in Combination With Psychologic Inoculation in Chronic Whiplash
Official title: Efficacy of Pain Neurophysiology Education in Combination With Psychologic Inoculation in Chronic Whiplash Associated Disorders : a Double-blind Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Pain, Chronic
Whiplash Injury
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2012-03-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: With the present study the investigators wish to examine if reconceptualisation of pain, by educating chronic whiplash-associated disorders (CWAD) patients on the neurophysiology of pain, in combination with psychologic innoculation is able to influence maladaptive (pain) cognitions, pain (inhibition) and movement performance, and reduce symptoms.

Detailed description: Results from a previous pilot study conducted by the same investigators suggest that intensive pain neurophysiology education (PNE) is able to increase pain thresholds and improve pain behavior and pain-free movement performance in patients with CWAD. However these results have not been confirmed in a randomized controlled trial.

In addition, it has been emphasized that PNE is not a standalone treatment and that future research should examine PNE in combination with other treatment modalities. Another treatment modality that challenges people's beliefs and barriers is psychological inoculation (PI). However, it has not yet been examined if PI could be a useful component in the rehabilitation of chronic pain patients.

Eligibility criteria: Inclusion Criteria:

* WAD grades I to II according to the Quebec Task Force criteria
* with chronic pain as result of a whiplash injury
* 18-65 years of age and with Dutch as their native language will be able to participate

Exclusion Criteria:

* other comorbidities or health issues that could explain the pain complaints
* \< 18years \> 65 years
* pregnant

Primary outcomes:
measure: Change in pain pressure thresholds (conditioned pain modulation)
timeFrame: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.
Secondary outcomes:
measure: Change in scores on the Neck Disability Index questionnaire
timeFrame: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.
measure: Changes in the scores on the Neurophysiology of Pain Test Questionnaire
timeFrame: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.
measure: Changes in scores on the Tampa Scale Kinesiophobia Questionnaire
timeFrame: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up
measure: Changes in scores on the Pain Catastrophizing Scale Questionnaire
timeFrame: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.
measure: Changes in score on the Pain Coping Inventory Questionnaire
timeFrame: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.
measure: Changes in the Chronic Pain Self Efficacy Questionnaire
timeFrame: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.
measure: Changes in the scores on the Whiplash Associated Disorders Symptom list
timeFrame: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.
measure: Changes in scores on the Short Form 36 questionnaire
timeFrame: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.
measure: Changes in range of movement and pain during the Brachial Plexus Provocation Test
timeFrame: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.
measure: Changes in pain during the Neck Extension Test
timeFrame: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.
measure: Changes is force during the Cranio Cervical Flexion Test
timeFrame: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline=day1
measure: Impact of Events Scale
timeFrame: Baseline=day 1
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Artesis College Antwerp
Study officials:
affiliation: Vrije Universiteit Brussel
name: Jo Nijs, Phd Msc
role: STUDY_DIRECTOR
References:
citation: 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.