Acupuncture Analgesia in Relation to Psychiatric Comorbidity (LBP)
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.
|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|
- Pain relief [ Time Frame: start and end ] [ Designated as safety issue: No ]%change in pain
|Study Start Date:||May 2004|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307788
|United States, Massachusetts|
|Pain Management Center|
|Chestnut Hill, Massachusetts, United States, 02167|
|Principal Investigator:||Ajay Wasan, M.D., MSc.||Brigham and Women's Hospital|
|Study Director:||Bruce Rosen, MD, PhD||Brigham and Womens Hospital|