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Does Acupuncture Activate Endogenous Pain Inhibition in Chronic Whiplash?

Primary Purpose

Whiplash

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
acupuncture
relaxation
Sponsored by
Vrije Universiteit Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Whiplash focused on measuring whiplash, chronic pain, sensitization, treatment, acupuncture, relaxation

Eligibility Criteria

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

Inclusion Criteria:

  • a diagnosis of chronic WAD grade 1 to 3 according to the criteria as defined by the Quebec Task Force classification
  • chronic neck pain and WAD persisting for at least 3 months
  • age between 18 and 65 years

Exclusion Criteria:

  • classified as WAD grade 4 (neck complaints including fracture or dislocation, or injury to the spinal cord)
  • pregnant
  • initiated a new conventional therapy during the study period
  • taking analgesic drugs 48 hours before testing and/or nicotine, alcohol and caffeine 24 hours before testing

Sites / Locations

  • Vrije Universiteit Brussel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

acupuncture

relaxation

Arm Description

All patients were treated at the basic points bilaterally situated in the local region (neck), distal region (low back, arms and legs) and ear. In addition, acupuncture treatment was performed according to the rules of traditional Chinese medicine and was semi-standardized. This means that the therapist was allowed to choose from a list of the following acupuncture points: GV14, Huatuojiaji C1-C7, GB20, SI11, GB21, TE15, SI14, BL17, MT10, SI3, BL64, TE5, GB41, Zero point, Jerome point, C0. The combination of acupuncture points were chosen individually, according to the patients' self-reported symptoms. In order to obtain the required information, patients had to fill out a Margolis pain diagram, and the acupuncturist questioned the patient and performed a tongue- and pulse diagnosis.

For the relaxation treatment the method of guided imagery is applied. Guided imagery is a system of visualization. During guided imagery relaxation, the patient's state of consciousness is similar to one which occurs in meditative status. Patients are instructed to listen to a CD with relaxation music (Arcade TV-CD Ad Vissesr's Brainsessions, track 3). Patients will sit in an identical position like during the acupuncture treatment (i.e. on a relaxation chair) and listened to the audio CD by headphone.

Outcomes

Primary Outcome Measures

the change in Conditioned pain modulation
For assessing CPM, the method examining the influence of the Diffuse Noxious Inhibitory Control system (or spatial summation) on temporal summation (TS) was applied. The experimental pain assessments before and after each treatment were carried out by the same assessor.

Secondary Outcome Measures

the change in Neck Disability Index (NDI)
The Neck Disability Index (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 when multiplied by two the percentage of disability can be obtained. The NDI is a valid and reliable instrument, sensitive to measure changes within a population of patient with neck pain.
the change in autonomic activity
For measuring autonomic activity, the Nexus 10 device (Mind Media, the Netherlands) will be used. Skin conductance, body temperature, heart rate, blood volume pressure and heart rate variability will be measured continuously in real time during CPM and during both treatment sessions. Electrodes will be placed on the left hand in all patients.
the change in scores obtained from the Whiplash Associated Disorders Symptom List
The Whiplash Associated Disorders Symptom List is a self-reported measure for assessing symptom severity in WAD patients. The questionnaire is composed of the most frequently reported WAD symptoms in the literature and some autonomic symptoms. Every symptom is presented by a visual analogue scale (VAS) (100 mm), a method that is known for its validity and reliability.

Full Information

First Posted
January 11, 2012
Last Updated
January 15, 2012
Sponsor
Vrije Universiteit Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT01512576
Brief Title
Does Acupuncture Activate Endogenous Pain Inhibition in Chronic Whiplash?
Official Title
Does Acupuncture Activate Endogenous Pain Inhibition in Chronic Whiplash Associated Disorders? A Randomized Cross-over Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

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
This physiological study examines whether acupuncture exerts short-term effects of analgesic mechanisms in patients with chronic whiplash pain. More specifically, it is examined whether acupuncture activates brain-orchestrated pain inhibitory action.
Detailed Description
Many patients with chronic pain, including those with chronic whiplash-associated disorders (WAD), show features of central sensitization (CS), a process characterized by generalized hypersensitivity of the somatosensory system. it would be worthwhile identifying treatments able of activating the dysfunctional endogenous pain inhibition in patients with CS and chronic WAD. Acupuncture is a treatment method widely used for patients with chronic pain, including those with chronic WAD. The effectiveness of acupuncture for the treatment of chronic (neck) pain is supported by several randomized controlled clinical trials, systematic reviews including meta-analyses. However, the effect-sizes are rather small and only short-term effects have been shown consistently. A randomized cross-over trial comparing acupuncture with relaxation is conducted in order to examine whether acupuncture vs. relaxation for patients with chronic WAD results in: Immediate activation of endogenous pain inhibition (i.e. conditioned pain modulation); Concomitant pain relief; And reduced disability level. Further it is examined whether acupuncture vs. relaxation results in different autonomic nervous system responses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whiplash
Keywords
whiplash, chronic pain, sensitization, treatment, acupuncture, relaxation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
acupuncture
Arm Type
Experimental
Arm Description
All patients were treated at the basic points bilaterally situated in the local region (neck), distal region (low back, arms and legs) and ear. In addition, acupuncture treatment was performed according to the rules of traditional Chinese medicine and was semi-standardized. This means that the therapist was allowed to choose from a list of the following acupuncture points: GV14, Huatuojiaji C1-C7, GB20, SI11, GB21, TE15, SI14, BL17, MT10, SI3, BL64, TE5, GB41, Zero point, Jerome point, C0. The combination of acupuncture points were chosen individually, according to the patients' self-reported symptoms. In order to obtain the required information, patients had to fill out a Margolis pain diagram, and the acupuncturist questioned the patient and performed a tongue- and pulse diagnosis.
Arm Title
relaxation
Arm Type
Active Comparator
Arm Description
For the relaxation treatment the method of guided imagery is applied. Guided imagery is a system of visualization. During guided imagery relaxation, the patient's state of consciousness is similar to one which occurs in meditative status. Patients are instructed to listen to a CD with relaxation music (Arcade TV-CD Ad Vissesr's Brainsessions, track 3). Patients will sit in an identical position like during the acupuncture treatment (i.e. on a relaxation chair) and listened to the audio CD by headphone.
Intervention Type
Other
Intervention Name(s)
acupuncture
Other Intervention Name(s)
complex somatosensory stimulation
Intervention Description
one 30-minute treatment session using sterile 1-time-use needles (Euro-acupuncture needles) were used, but the therapist was allowed to chose the needle length and diameter
Intervention Type
Behavioral
Intervention Name(s)
relaxation
Other Intervention Name(s)
visualization
Intervention Description
1 treatment session of 30 minutes
Primary Outcome Measure Information:
Title
the change in Conditioned pain modulation
Description
For assessing CPM, the method examining the influence of the Diffuse Noxious Inhibitory Control system (or spatial summation) on temporal summation (TS) was applied. The experimental pain assessments before and after each treatment were carried out by the same assessor.
Time Frame
measured prior to (week 1 and week 2) and immediately following (week1 and week 2) each treatment session
Secondary Outcome Measure Information:
Title
the change in Neck Disability Index (NDI)
Description
The Neck Disability Index (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 when multiplied by two the percentage of disability can be obtained. The NDI is a valid and reliable instrument, sensitive to measure changes within a population of patient with neck pain.
Time Frame
measured prior to (week 1 and 2) and immediately following (week 1 and 2) each treatment session
Title
the change in autonomic activity
Description
For measuring autonomic activity, the Nexus 10 device (Mind Media, the Netherlands) will be used. Skin conductance, body temperature, heart rate, blood volume pressure and heart rate variability will be measured continuously in real time during CPM and during both treatment sessions. Electrodes will be placed on the left hand in all patients.
Time Frame
week 1 and 2 : measured continuously in real time during CPM and during both treatment sessions
Title
the change in scores obtained from the Whiplash Associated Disorders Symptom List
Description
The Whiplash Associated Disorders Symptom List is a self-reported measure for assessing symptom severity in WAD patients. The questionnaire is composed of the most frequently reported WAD symptoms in the literature and some autonomic symptoms. Every symptom is presented by a visual analogue scale (VAS) (100 mm), a method that is known for its validity and reliability.
Time Frame
measured prior to (week 1 and 2) and immediately following (week 1 and 2) each treatment session

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: a diagnosis of chronic WAD grade 1 to 3 according to the criteria as defined by the Quebec Task Force classification chronic neck pain and WAD persisting for at least 3 months age between 18 and 65 years Exclusion Criteria: classified as WAD grade 4 (neck complaints including fracture or dislocation, or injury to the spinal cord) pregnant initiated a new conventional therapy during the study period taking analgesic drugs 48 hours before testing and/or nicotine, alcohol and caffeine 24 hours before testing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jo Nijs, PhD
Organizational Affiliation
Vrije Universiteit Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vrije Universiteit Brussel
City
Brussel
ZIP/Postal Code
B-1050
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
21254866
Citation
Nijs J, Meeus M, Van Oosterwijck J, Roussel N, De Kooning M, Ickmans K, Matic M. Treatment of central sensitization in patients with 'unexplained' chronic pain: what options do we have? Expert Opin Pharmacother. 2011 May;12(7):1087-98. doi: 10.1517/14656566.2011.547475. Epub 2011 Jan 22.
Results Reference
background
PubMed Identifier
19160000
Citation
Nijs J, Van Oosterwijck J, De Hertogh W. Rehabilitation of chronic whiplash: treatment of cervical dysfunctions or chronic pain syndrome? Clin Rheumatol. 2009 Mar;28(3):243-51. doi: 10.1007/s10067-008-1083-x. Epub 2009 Jan 22.
Results Reference
background
PubMed Identifier
21853277
Citation
Nijs J, Inghelbrecht E, Daenen L, Hachimi-Idrissi S, Hens L, Willems B, Roussel N, Cras P, Wouters K, Bernheim J. Recruitment bias in chronic pain research: whiplash as a model. Clin Rheumatol. 2011 Nov;30(11):1481-9. doi: 10.1007/s10067-011-1829-8. Epub 2011 Aug 19.
Results Reference
background

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Does Acupuncture Activate Endogenous Pain Inhibition in Chronic Whiplash?

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