Clinical trial NCT00307788: Acupuncture Analgesia in Relation to Psychiatric Comorbidity
Official title: The Association Amongst Acupuncture Analgesia, Expectancy, and Psychiatric Comorbidity in Patients With Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Keywords: Psychiatric Comorbidity
Acupuncture
expectancy
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2006-03-28
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Pain relief
timeFrame: start and end
Secondary outcomes:
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Pain Management Center
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Ajay Wasan, M.D., MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Womens Hospital
name: Bruce Rosen, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Wasan AD, Kong J, Pham LD, Kaptchuk TJ, Edwards R, Gollub RL. The impact of placebo, psychopathology, and expectations on the response to acupuncture needling in patients with chronic low back pain. J Pain. 2010 Jun;11(6):555-63. doi: 10.1016/j.jpain.2009.09.013. Epub 2010 Jan 13.