NCT01544075

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 5, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2015

Enrollment Period

3.6 years

First QC Date

February 21, 2012

Last Update Submit

June 2, 2015

Conditions

Pain, ChronicWhiplash Injury

Outcome Measures

Primary Outcomes (1)

  • Change in pain pressure thresholds (conditioned pain modulation)

    Measures over different locations on the body. Used as test stimulus while a conditioning stimulus is applied (conditioned pain modulation).

    Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.

Secondary Outcomes (13)

  • Change in scores on the Neck Disability Index questionnaire

    Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.

  • Changes in the scores on the Neurophysiology of Pain Test Questionnaire

    Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.

  • Changes in scores on the Tampa Scale Kinesiophobia Questionnaire

    Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up

  • Changes in scores on the Pain Catastrophizing Scale Questionnaire

    Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.

  • Changes in score on the Pain Coping Inventory Questionnaire

    Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.

  • +8 more secondary outcomes

Study Arms (2)

PNE+PI

EXPERIMENTAL

The interventional group who will receive the experimental PNE+PI treatment.

Behavioral: Pain neurophysiology education (PNE) and psychologic inoculation (PI)

NS

ACTIVE COMPARATOR

The control group who will receive the neck school treatment.

Behavioral: Neck school (NS)

Interventions

Pain neurophysiology education (PNE) and psychologic inoculation (PI)BEHAVIORAL

3 sessions of PNE+PI are given which include education on pain neurophysiology and applying the PI technique for which subjects are asked to refute sentences which are read by the therapist.

PNE+PI
Neck school (NS)BEHAVIORAL

3 sessions of NS which includes advice on posture, ergonomics and on performing activities.

NS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Artesis College Antwerp

Antwerp, 2170, Belgium

Location

Related Publications (1)

  • 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: 21328162BACKGROUND

MeSH Terms

Conditions

Chronic PainWhiplash Injuries

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeck InjuriesWounds and Injuries

Study Officials

  • Jo Nijs, Phd Msc

    Vrije Universiteit Brussel

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 21, 2012

First Posted

March 5, 2012

Study Start

February 1, 2012

Primary Completion

September 1, 2015

Last Updated

June 3, 2015

Record last verified: 2015-06

Locations

BE(1)