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

Primary Purpose

Pain, Chronic, Whiplash Injury

Status
Unknown status
Phase
Early Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Pain neurophysiology education (PNE) and psychologic inoculation (PI)
Neck school (NS)
Sponsored by
Vrije Universiteit Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Chronic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Artesis College Antwerp

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PNE+PI

NS

Arm Description

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

The control group who will receive the neck school treatment.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
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.
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).
Changes in the Chronic Pain Self Efficacy Questionnaire
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
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
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
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
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
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
This questionnaire wil be used in order to examine whether patients are depressed.
Impact of Events Scale
This questionnaire will be used in order to examine whether post traumatic stress disorder in present in the patients.

Full Information

First Posted
February 21, 2012
Last Updated
June 2, 2015
Sponsor
Vrije Universiteit Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT01544075
Brief Title
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

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic, Whiplash Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PNE+PI
Arm Type
Experimental
Arm Description
The interventional group who will receive the experimental PNE+PI treatment.
Arm Title
NS
Arm Type
Active Comparator
Arm Description
The control group who will receive the neck school treatment.
Intervention Type
Behavioral
Intervention Name(s)
Pain neurophysiology education (PNE) and psychologic inoculation (PI)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Neck school (NS)
Intervention Description
3 sessions of NS which includes advice on posture, ergonomics and on performing activities.
Primary Outcome Measure Information:
Title
Change in pain pressure thresholds (conditioned pain modulation)
Description
Measures over different locations on the body. Used as test stimulus while a conditioning stimulus is applied (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.
Secondary Outcome Measure Information:
Title
Change in scores on the Neck Disability Index questionnaire
Description
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.
Time Frame
Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.
Title
Changes in the scores on the Neurophysiology of Pain Test Questionnaire
Description
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.
Time Frame
Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.
Title
Changes in scores on the Tampa Scale Kinesiophobia Questionnaire
Description
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.
Time Frame
Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up
Title
Changes in scores on the Pain Catastrophizing Scale Questionnaire
Description
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.
Time Frame
Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.
Title
Changes in score on the Pain Coping Inventory Questionnaire
Description
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).
Time Frame
Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.
Title
Changes in the Chronic Pain Self Efficacy Questionnaire
Description
This is a questionnaire which can be used to measure self efficacy in chronic pain patients.
Time Frame
Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.
Title
Changes in the scores on the Whiplash Associated Disorders Symptom list
Description
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.
Time Frame
Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.
Title
Changes in scores on the Short Form 36 questionnaire
Description
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.
Time Frame
Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.
Title
Changes in range of movement and pain during the Brachial Plexus Provocation Test
Description
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.
Time Frame
Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.
Title
Changes in pain during the Neck Extension Test
Description
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.
Time Frame
Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.
Title
Changes is force during the Cranio Cervical Flexion Test
Description
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.
Time Frame
Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.
Title
Hospital Anxiety and Depression Scale
Description
This questionnaire wil be used in order to examine whether patients are depressed.
Time Frame
Baseline=day1
Title
Impact of Events Scale
Description
This questionnaire will be used in order to examine whether post traumatic stress disorder in present in the patients.
Time Frame
Baseline=day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jo Nijs, Phd Msc
Organizational Affiliation
Vrije Universiteit Brussel
Official's Role
Study Director
Facility Information:
Facility Name
Artesis College Antwerp
City
Antwerp
ZIP/Postal Code
2170
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
21328162
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.
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Efficacy of Pain Neurophysiology Education in Combination With Psychologic Inoculation in Chronic Whiplash

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