Does Acupuncture Activate Endogenous Pain Inhibition in Chronic Whiplash?

Whiplash Clinical Trial

Official title:

Does Acupuncture Activate Endogenous Pain Inhibition in Chronic Whiplash Associated Disorders? A Randomized Cross-over Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512576
• Other study ID #: AcuWAD
• Status: Completed
• Phase: Phase 2
• First received: January 11, 2012
• Last updated: January 15, 2012
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Whiplash
• Whiplash Injuries

Intervention

Other:
• 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

Behavioral:
• relaxation
1 treatment session of 30 minutes

Locations

Country	Name	City	State
Belgium	Vrije Universiteit Brussel	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	measured prior to (week 1 and week 2) and immediately following (week1 and week 2) each treatment session	No
Secondary	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.	measured prior to (week 1 and 2) and immediately following (week 1 and 2) each treatment session	No
Secondary	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.	week 1 and 2 : measured continuously in real time during CPM and during both treatment sessions	No
Secondary	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.	measured prior to (week 1 and 2) and immediately following (week 1 and 2) each treatment session	No

External Links

•   Belgian research group on chronic pain and chronic fatigue