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Pain, ChronicEarly Phase 1NCT01544075

Efficacy of Pain Neurophysiology Education in Combination With Psychologic Inoculation in Chronic Whiplash

A Early Phase 1 study testing Pain neurophysiology education (PNE) and psychologic inoculation (PI) and Neck school (NS) in people with Pain, Chronic and Whiplash Injury, run by Vrije Universiteit Brussel at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Pain, Chronic, Whiplash Injury
What is being tested?
Pain neurophysiology education (PNE) and psychologic inoculation (PI) and Neck school (NS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteBelgium
Study dates
Feb 2012to Sep 2015
Phase
Early Phase 1
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

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Artesis College Antwerp

    Antwerp, 2170

Other trials in Belgium

About this study

Official title: Efficacy of Pain Neurophysiology Education in Combination With Psychologic Inoculation in Chronic Whiplash Associated Disorders : a Double-blind Randomised Controlled Trial

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.

Read the 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.

Being tested
Pain neurophysiology education (PNE) and psychologic inoculation (PI), Neck school (NS)
Medical subject headings
Chronic Pain, Whiplash Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pain neurophysiology education (PNE) and psychologic inoculation (PI)Behavioural

    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.

  • Neck school (NS)Behavioural

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

Study groups in NCT01544075
Study groupRoleWhat they receive
PNE+PIExperimentalThe interventional group who will receive the experimental PNE+PI treatment.
Receives: Behavioral: Pain neurophysiology education (PNE) and psychologic inoculation (PI)
NSActive comparatorThe control group who will receive the neck school treatment.
Receives: Behavioral: Neck school (NS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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: 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)
  1. Change in scores on the Neck Disability Index questionnaire

    The NDI was developed in 1991 as a modification of the Oswestry Back Pain Index and was the first instrument designed to assess self-rated disability in patients with neck pain. The NDI is scored from 0 (good function) to 50(poor function), and the percentage of disability can be obtained when the score is multiplied by two. The NDI is a valid and reliable instrument sensitive to measure changes within a population of patients with neck pain.

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

  2. Changes in the scores on the Neurophysiology of Pain Test Questionnaire

    This is a questionnaire developed by Moseley et al. which assess the knwoledge of pain physiology in patients. A total score of 19 can be obtained when adding up one point for each item anwsered correctly.

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

  3. Changes in scores on the Tampa Scale Kinesiophobia Questionnaire

    The TSK is a 17-item questionnaire that measures the fear of (re)injury due to movement [48]. Items are scored on a 4-point Likert scale, and a total score is calculated(1-4 for each item) after inversion of the individual scores of items 4, 8, 12, and 16. The total scores for the TSK range from 17 to 68.

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

  4. Changes in scores on the Pain Catastrophizing Scale Questionnaire

    This selfreported questionnaire measures catastrophic thinking about pain and consists of 13 items describing different thoughts and feelings that individuals may experience when experiencing pain. Items are scored on a 5-point scale, and one general score can be obtained for the degree of catastrophic thoughts about pain by adding up all individual item scores. This general score can be subdivided into three subscales: Helplessness, Magnification, and Rumination. Higher scores correspond to more severe catastrophic thoughts about pain.

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

  5. Changes in score on the Pain Coping Inventory Questionnaire

    The PCI consists of six scales (33 items) measuring cognitive and behavioral pain-coping strategies that represent two higher order pain coping dimensions: active(distraction, transformation, and reducing demands) and passive (resting, retreating, and worrying).

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

  6. Changes in the Chronic Pain Self Efficacy Questionnaire

    This is a questionnaire which can be used to measure self efficacy in chronic pain patients.

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

  7. Changes in the scores on the Whiplash Associated Disorders Symptom list

    This is a self-reported measure for assessing symptom severity in patients with WAD. The questionnaire is composed of the most reported WAD symptoms in the literature and some autonomic symptoms. Every symptom is presented by a visual analog scale (VAS) (100 mm), a method that is known for its validity and reliability.

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

  8. Changes in scores on the Short Form 36 questionnaire

    The SF-36 is a questionnaire to measure general health. Score reach from 0 to 100, and higher scores are obtained when havind a better general health.

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

  9. Changes in range of movement and pain during the Brachial Plexus Provocation Test

    Brachial Plexus Provocation Test is a neurodynamic test during which the range of elbow extension corresponding with the moment of "pain onset" and "submaximal pain" can be measured reliably, both in laboratory and clinical conditions. At the completion of the test, the subjects are asked to rate pain on a Visual Analogue Scale.

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

  10. Changes in pain during the Neck Extension Test

    The Neck Extension Test is used to diagnose sensory disturbances in patients with whiplash and is able to discriminate between subjects with symptoms after a whiplash injury and subjects without head or neck complaints. During cervical extension the patient's willingness to perform the movement is registered and the degree of pain experienced during the test performance is measured using a VAS.

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

  11. Changes is force during the Cranio Cervical Flexion Test

    This is a clinical test of the anatomical action of the deep cervical flexor muscles and evaluates neuromotor control. The features assessed are the activation and isometric endurance of the deep cervical flexors as well as their interaction with the superficial cervical flexors during the performance of five progressive stages of increasing craniocervical flexion range of motion. It is a low-load test performed in the supine position with the patient guided to each stage by feedback from a pressure sensor placed behind the neck.

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

  12. Hospital Anxiety and Depression Scale

    This questionnaire wil be used in order to examine whether patients are depressed.

    Measured: Baseline=day1

  13. Impact of Events Scale

    This questionnaire will be used in order to examine whether post traumatic stress disorder in present in the patients.

    Measured: Baseline=day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionSep 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01544075
Sponsor's protocol ID
143201112788
Status last verified
Jun 2015
First submitted
21 Feb 2012
Last updated
3 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21328162

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Pain neurophysiology education (PNE) and psychologic inoculation (PI) and Neck school (NS) in people with Pain, Chronic and Whiplash Injury, run by Vrije Universiteit Brussel at 1 site 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Change in pain pressure thresholds (conditioned pain modulation) (time frame: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.). 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 NCT01544075, which also lists 1 linked publication.

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 3 Jun 2015.

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