Clinical trial NCT01512576: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Whiplash
Keywords: whiplash
chronic pain
sensitization
treatment
acupuncture
relaxation
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2012-01-19
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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:

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.

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

Primary outcomes:
measure: the change in Conditioned pain modulation
timeFrame: measured prior to (week 1 and week 2) and immediately following (week1 and week 2) each treatment session
Secondary outcomes:
measure: the change in Neck Disability Index (NDI)
timeFrame: measured prior to (week 1 and 2) and immediately following (week 1 and 2) each treatment session
measure: the change in autonomic activity
timeFrame: week 1 and 2 : measured continuously in real time during CPM and during both treatment sessions
measure: the change in scores obtained from the Whiplash Associated Disorders Symptom List
timeFrame: measured prior to (week 1 and 2) and immediately following (week 1 and 2) each treatment session
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Vrije Universiteit Brussel
Study officials:
affiliation: Vrije Universiteit Brussel
name: Jo Nijs, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.