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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Vrije Universiteit Brussel.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Jessica Van Oosterwijck, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier:
NCT01544075
First received: February 21, 2012
Last updated: March 2, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Pain, Chronic
Whiplash Injury
Behavioral: Pain neurophysiology education and psychologic inoculation
Behavioral: Neck school
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Pain Neurophysiology Education in Combination With Psychologic Inoculation in Chronic Whiplash Associated Disorders : a Double-blind Randomised Controlled Trial

Further study details as provided by Vrije Universiteit Brussel:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Measures over different locations on the body. Used as test stimulus while a conditioning stimulus is applied (conditioned pain modulation).


Secondary Outcome Measures:
  • Change in scores on the Neck Disability Index questionnaire [ Time Frame: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up. ] [ Designated as safety issue: No ]
    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.

  • Changes in the scores on the Neurophysiology of Pain Test Questionnaire [ Time Frame: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up. ] [ Designated as safety issue: No ]
    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.

  • Changes in scores on the Tampa Scale Kinesiophobia Questionnaire [ Time Frame: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up ] [ Designated as safety issue: No ]
    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.

  • Changes in scores on the Pain Catastrophizing Scale Questionnaire [ Time Frame: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up. ] [ Designated as safety issue: No ]
    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.

  • Changes in score on the Pain Coping Inventory Questionnaire [ Time Frame: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up. ] [ Designated as safety issue: No ]
    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).

  • Changes in the Chronic Pain Self Efficacy Questionnaire [ Time Frame: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up. ] [ Designated as safety issue: No ]
    This is a questionnaire which can be used to measure self efficacy in chronic pain patients.

  • Changes in the scores on the Whiplash Associated Disorders Symptom list [ Time Frame: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up. ] [ Designated as safety issue: No ]
    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.

  • Changes in scores on the Short Form 36 questionnaire [ Time Frame: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up. ] [ Designated as safety issue: No ]
    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.

  • Changes in range of movement and pain during the Brachial Plexus Provocation Test [ Time Frame: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up. ] [ Designated as safety issue: No ]
    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.

  • Changes in pain during the Neck Extension Test [ Time Frame: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up. ] [ Designated as safety issue: No ]
    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.

  • Changes is force during the Cranio Cervical Flexion Test [ Time Frame: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up. ] [ Designated as safety issue: No ]
    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.

  • Hospital Anxiety and Depression Scale [ Time Frame: Baseline=day1 ] [ Designated as safety issue: No ]
    This questionnaire wil be used in order to examine whether patients are depressed.

  • Impact of Events Scale [ Time Frame: Baseline=day 1 ] [ Designated as safety issue: No ]
    This questionnaire will be used in order to examine whether post traumatic stress disorder in present in the patients.


Estimated Enrollment: 36
Study Start Date: February 2012
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PNE+PI
The interventional group who will receive the experimental PNE+PI treatment.
Behavioral: Pain neurophysiology education and psychologic inoculation
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.
Active Comparator: NS
The control group who will receive the neck school treatment.
Behavioral: Neck school
3 sessions of Neck school which includes advice on posture, ergonomics and on performing activities.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544075

Contacts
Contact: Jessica Van Oosterwijck, Phd Msc 026292753 ext +32 jvooster@vub.ac.be

Locations
Belgium
Artesis College Antwerp Recruiting
Antwerp, Belgium, 2170
Sponsors and Collaborators
Vrije Universiteit Brussel
Investigators
Study Director: Jo Nijs, Phd Msc Vrije Universiteit Brussel
  More Information

Publications:
Responsible Party: Jessica Van Oosterwijck, Dr., Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT01544075     History of Changes
Other Study ID Numbers: 143201112788
Study First Received: February 21, 2012
Last Updated: March 2, 2012
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Whiplash Injuries
Chronic Pain
Wounds and Injuries
Neck Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014