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NCT Number: NCT01512576

Does Acupuncture Activate Endogenous Pain Inhibition in Chronic Whiplash?

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vrije Universiteit Brussel

Brussels, B-1050, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: complex somatosensory stimulation

Relaxation

Behavioral

1 treatment session of 30 minutes

Other names: visualization

Primary outcomes

  1. the change in Conditioned pain modulation

    Time frame: measured prior to (week 1 and week 2) and immediately following (week1 and week 2) each treatment session

    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 outcomes

  1. the change in Neck Disability Index (NDI)

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

    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.

  2. the change in autonomic activity

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

    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.

  3. the change in scores obtained from the Whiplash Associated Disorders Symptom List

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

    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.

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 19, 2012
Registry last updated
Jan 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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