Does Acupuncture Activate Endogenous Pain Inhibition in Chronic Whiplash?

NCT01512576 | Completed Phase 2

• 1 other identifier: AcuWAD
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Whiplash

Keywords

whiplash; chronic pain; sensitization; treatment; acupuncture; relaxation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• the change in Neck Disability Index (NDI)

  measured prior to (week 1 and 2) and immediately following (week 1 and 2) each treatment session

• the change in autonomic activity

  week 1 and 2 : measured continuously in real time during CPM and during both treatment sessions

• the change in scores obtained from the Whiplash Associated Disorders Symptom List

  measured prior to (week 1 and 2) and immediately following (week 1 and 2) each treatment session

Study Arms (2)

acupuncture

EXPERIMENTAL

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.

Other: acupuncture

relaxation

ACTIVE COMPARATOR

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.

Behavioral: relaxation

Interventions

acupuncture 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

Also known as: complex somatosensory stimulation

acupuncture

relaxation BEHAVIORAL

1 treatment session of 30 minutes

Also known as: visualization

relaxation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (1)

Vrije Universiteit Brussel

Brussels, B-1050, Belgium

Location

Related Publications (3)

• 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.

  PMID: 21254866 BACKGROUND

• 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.

  PMID: 19160000 BACKGROUND

• 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.

  PMID: 21853277 BACKGROUND

MeSH Terms

Conditions

Whiplash Injuries; Chronic Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neck Injuries; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Jo Nijs, PhD

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 11, 2012
• First Posted: January 19, 2012
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 19, 2012

Record last verified: 2012-01

Locations

BE (1)