Acupuncture Analgesia in Relation to Psychiatric Comorbidity (LBP)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ajay D. Wasan,M.D.,M.Sc., Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00307788
First received: March 24, 2006
Last updated: May 24, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Low Back Pain
Procedure: acupuncture
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Association Amongst Acupuncture Analgesia, Expectancy, and Psychiatric Comorbidity in Patients With Low Back Pain

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Pain relief [ Time Frame: start and end ] [ Designated as safety issue: No ]
    %change in pain


Enrollment: 60
Study Start Date: May 2004
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: acupuncture
    acupuncture
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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00307788

Locations
United States, Massachusetts
Pain Management Center
Chestnut Hill, Massachusetts, United States, 02167
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Ajay Wasan, M.D., MSc. Brigham and Women's Hospital
Study Director: Bruce Rosen, MD, PhD Brigham and Womens Hospital
  More Information

No publications provided by Brigham and Women's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ajay D. Wasan,M.D.,M.Sc., Psychiatrist, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00307788     History of Changes
Other Study ID Numbers: 2004P001139, P01AT002048-01
Study First Received: March 24, 2006
Last Updated: May 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Psychiatric Comorbidity
Acupuncture
expectancy

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

ClinicalTrials.gov processed this record on August 20, 2014