Acupuncture Analgesia in Relation to Psychiatric Comorbidity (LBP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00307788
Recruitment Status : Completed
First Posted : March 28, 2006
Last Update Posted : May 25, 2012
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Ajay D. Wasan,M.D.,M.Sc., Brigham and Women's Hospital

Brief Summary:
It is our hypothesis that patient's expectations concerning treatment outcome will be influenced by their psychiatric symptoms, and that this expectancy will have a strong influence on the efficacy of acupuncture treatment to suppress experimentally induced pain. We will conduct a study, monitoring expectations but not manipulating them, in a cohort of patients with chronic low back pain.

Condition or disease Intervention/treatment Phase
Low Back Pain Procedure: acupuncture Phase 3

Detailed Description:

Specific Aim: To characterize subjective analgesia (behavioral effect) of different expectancy levels on verum and sham acupuncture treatment and the relative contribution of acupuncture treatment and expectancy to the resultant analgesia in healthy normals and in those with low back pain, controlling for psychiatric comorbidity.

Hypothesis 1: Patients with low back pain, low psychiatric comorbidity, and high expectations for acupuncture treatment will experience the same magnitude of acupuncture analgesia to thermal pain stimuli as healthy volunteers with high expectations for treatment.

Hypothesis 2: Patients with low back pain and high psychiatric comorbidity will experience less acupuncture analgesia compared to patients with low back pain and low psychiatric comorbidity, regardless of the level of expectations for acupuncture treatment.

Hypothesis 3: Patients with low back pain and high psychiatric comorbidity will have increased acupuncture placebo analgesia to thermal pain stimuli than both other groups.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Association Amongst Acupuncture Analgesia, Expectancy, and Psychiatric Comorbidity in Patients With Low Back Pain
Study Start Date : May 2004
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Intervention Details:
  • Procedure: acupuncture

Primary Outcome Measures :
  1. Pain relief [ Time Frame: start and end ]
    %change in pain

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Volunteers between 21 and 65 years of age with discogenic low back pain, either with or without radicular pain for more than three months, assessed by the treating physician with the use of imaging. Patients with discogenic low back are chosen in order to study a more uniform pain syndrome, a concern in pain medicine research [153]. Patients must have pain for at least three months because 90% of back pain resolves within three months of onset, and back pain beyond this time is more likely to remain chronic [156].
  2. Average pain intensity of ≥4 on a scale from 0 to 10, because <4 is considered a level with acceptable pain and function
  3. At least an 8th grade English-reading level; English can be a second language provided that the subjects feel they understand all the questions used in the assessment measures.
  4. No long-acting opioids. Short acting opioids are acceptable, provided that subjects undergo a 7-10 day washout period. It is not possible to recruit an entirely opioid naïve population.
  5. No prescription benzodiazepines.

Exclusion Criteria:

  1. Any interventional procedure for low back or radicular pain two weeks prior to the study or during the two week study period, such as lumbar epidural steroids, nerve root blocks, or facet joint injections/ radiofrequency lesioning.
  2. Having received acupuncture treatment before for any condition.
  3. Back surgery in the previous 12 weeks, the intent to undergo back surgery during the study period, or any clinically unstable systemic illness that is judged to interfere with the trial.
  4. Non-ambulatory status
  5. History of cardiac or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome.
  6. An inability to complete questionnaires accurately.
  7. . Current opioid treatment through an intrathecal device
  8. Cancer or other malignant disease, except carcinoma in situ of the skin or cervix

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00307788

United States, Massachusetts
Pain Management Center
Chestnut Hill, Massachusetts, United States, 02167
Sponsors and Collaborators
Brigham and Women's Hospital
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Ajay Wasan, M.D., MSc. Brigham and Women's Hospital
Study Director: Bruce Rosen, MD, PhD Brigham and Womens Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ajay D. Wasan,M.D.,M.Sc., Psychiatrist, Brigham and Women's Hospital Identifier: NCT00307788     History of Changes
Other Study ID Numbers: 2004P001139
P01AT002048-01 ( U.S. NIH Grant/Contract )
First Posted: March 28, 2006    Key Record Dates
Last Update Posted: May 25, 2012
Last Verified: May 2012

Keywords provided by Ajay D. Wasan,M.D.,M.Sc., Brigham and Women's Hospital:
Psychiatric Comorbidity

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms