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Does Acupuncture Activate Endogenous Pain Inhibition in Chronic Whiplash?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jo Nijs, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier:
NCT01512576
First received: January 11, 2012
Last updated: January 15, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Whiplash
Other: acupuncture
Behavioral: relaxation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Acupuncture Activate Endogenous Pain Inhibition in Chronic Whiplash Associated Disorders? A Randomized Cross-over Trial

Resource links provided by NLM:


Further study details as provided by Vrije Universiteit Brussel:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • the change in autonomic activity [ Time Frame: week 1 and 2 : measured continuously in real time during CPM and during both treatment sessions ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 39
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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
Other Name: complex somatosensory stimulation
Active Comparator: 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.
Behavioral: relaxation
1 treatment session of 30 minutes
Other Name: visualization

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512576

Locations
Belgium
Vrije Universiteit Brussel
Brussel, Belgium, B-1050
Sponsors and Collaborators
Vrije Universiteit Brussel
Investigators
Principal Investigator: Jo Nijs, PhD Vrije Universiteit Brussel
  More Information

Publications:
Responsible Party: Jo Nijs, Associate professor, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT01512576     History of Changes
Other Study ID Numbers: AcuWAD
Study First Received: January 11, 2012
Last Updated: January 15, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by Vrije Universiteit Brussel:
whiplash
chronic pain
sensitization
treatment
acupuncture
relaxation

Additional relevant MeSH terms:
Whiplash Injuries
Neck Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014