Does Acupuncture Activate Endogenous Pain Inhibition in Chronic Whiplash?

NCT ID: NCT01512576

Last Updated: 2012-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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:

1. Immediate activation of endogenous pain inhibition (i.e. conditioned pain modulation);
2. Concomitant pain relief;
3. And reduced disability level. Further it is examined whether acupuncture vs. relaxation results in different autonomic nervous system responses.

Conditions

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Whiplash

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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acupuncture

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.

Group Type EXPERIMENTAL

acupuncture

Intervention Type OTHER

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

relaxation

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.

Group Type ACTIVE_COMPARATOR

relaxation

Intervention Type BEHAVIORAL

1 treatment session of 30 minutes

Interventions

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acupuncture

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 OTHER

relaxation

1 treatment session of 30 minutes

Intervention Type BEHAVIORAL

Other Intervention Names

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complex somatosensory stimulation visualization

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vrije Universiteit Brussel

OTHER

Sponsor Role lead

Responsible Party

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Jo Nijs

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jo Nijs, PhD

Role: PRINCIPAL_INVESTIGATOR

Vrije Universiteit Brussel

Locations

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Vrije Universiteit Brussel

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 21254866 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19160000 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21853277 (View on PubMed)

Other Identifiers

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AcuWAD

Identifier Type: -

Identifier Source: org_study_id

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