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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00307788 |
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 |
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Low Back Pain |
Procedure: acupuncture |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | The Association Amongst Acupuncture Analgesia, Expectancy, and Psychiatric Comorbidity in Patients With Low Back Pain |
Estimated Enrollment: | 60 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | May 2008 |
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.
Ages Eligible for Study: | 21 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | P01 AT002048-01 |
Study First Received: | March 24, 2006 |
Last Updated: | September 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00307788 History of Changes |
Health Authority: | United States: Federal Government |
Psychiatric Comorbidity Acupuncture expectancy |
Signs and Symptoms Neurologic Manifestations Low Back Pain Pain Back Pain |
Signs and Symptoms Nervous System Diseases Neurologic Manifestations |
Low Back Pain Pain Back Pain |