Acupuncture Analgesia in Relation to Psychiatric Comorbidity

Completed · Phase 3

Conditions studied: Low Back Pain

In brief

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.

Key facts

Study ID: NCT00307788
Run by: Brigham and Women's Hospital
People needed: 60
Starts: 2004-05-01
Expected to finish: 2010-05-01
Last updated by the study team: 2012-05-25

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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].
Average pain intensity of ≥4 on a scale from 0 to 10, because <4 is considered a level with acceptable pain and function
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.
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.
No prescription benzodiazepines.

You may not qualify if…

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.
Having received acupuncture treatment before for any condition.
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.
Non-ambulatory status
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.
An inability to complete questionnaires accurately.
. Current opioid treatment through an intrathecal device
Cancer or other malignant disease, except carcinoma in situ of the skin or cervix

Where it is running

Pain Management Center — Chestnut Hill, Massachusetts, United States

Full record on ClinicalTrials.gov

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