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Acupuncture Analgesia in Relation to Psychiatric Comorbidity (LBP)

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
acupuncture
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Psychiatric Comorbidity, Acupuncture, expectancy

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • Pain Management Center

Outcomes

Primary Outcome Measures

Pain relief
%change in pain

Secondary Outcome Measures

Full Information

First Posted
March 24, 2006
Last Updated
May 24, 2012
Sponsor
Brigham and Women's Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00307788
Brief Title
Acupuncture Analgesia in Relation to Psychiatric Comorbidity
Acronym
LBP
Official Title
The Association Amongst Acupuncture Analgesia, Expectancy, and Psychiatric Comorbidity in Patients With Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Psychiatric Comorbidity, Acupuncture, expectancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
acupuncture
Intervention Description
acupuncture
Primary Outcome Measure Information:
Title
Pain relief
Description
%change in pain
Time Frame
start and end

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ajay Wasan, M.D., MSc.
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruce Rosen, MD, PhD
Organizational Affiliation
Brigham and Womens Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Pain Management Center
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02167
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20075014
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.
Results Reference
derived

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Acupuncture Analgesia in Relation to Psychiatric Comorbidity

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