Brain Imaging Study of Acupuncture in Chronic Low Back Pain

Study Overview
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Brief Summary
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We are doing this research study to learn about how acupuncture treatment works. This study is being done to look at changes in the brain, NOT to treat pain. We want to learn about brain activity during acupuncture. We will look at brain activity when a heating device touches the skin of a subject before and after the subject has acupuncture, to see what changes.

Official Title
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A Physiological fMRI Study of Acupuncture and Perceptions of Pain in Chronic Low Back Pain Patients.

Conditions
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Low Back Pain, Back Pain Lower Back Chronic, Low Back Pain, Recurrent

Intervention / Treatment
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* Procedure: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the Classification Criteria of chronic LBP (having low back pain for more than 6 months), as determined by the referring physician At least 4/10 clinical pain on the 10-point LBP intensity scale on average during the past two weeks prior to enrollment At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures Must have had a prior evaluation of their low back pain by a health care provider, which may include radiographic studies. Documentation of this evaluation will be obtained from the subject's medical record Exclusion Criteria: Specific causes of back pain (e.g., cancer, fractures, spinal stenosis, infections) Radicular pain extending below the knee Complicated back problems (e.g., prior back surgery, medicolegal issues) Possible contraindications for acupuncture (e.g., coagulation disorders, cardiac pacemakers, pregnancy, seizure disorder), and conditions that might confound treatment effects or interpretation of results (e.g., severe fibromyalgia, rheumatoid arthritis) Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator and/or a T score > 60 on the psychological measures assessed during Session 1) Prior acupuncture treatment for back pain; 1 year minimum wait for any condition other condition. Active substance abuse disorder in the past two years, as determined by subject self-report. The intent to undergo surgery during the time of involvement in the study. History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome. For example: asthma or claustrophobia. Presence of any contraindications to MRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy. Unresolved legal/disability/workers compensation claims in connection with low back. Instability of pain ratings in Session 2 or Session 3. Use of more than 60 mg prescription opioids or steroids for pain.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traditional Acupuncture<br>Traditional Acupuncture given at 2 visits. | Procedure: Acupuncture<br>* A licensed acupuncturist will perform acupuncture for two 30 minute sessions.<br>|
| Experimental: Electroacupuncture<br>Electro-acupuncture given at 2 visits. | Procedure: Acupuncture<br>* A licensed acupuncturist will perform acupuncture for two 30 minute sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain changes to acupuncture | The effects of pain on the brain | 3 visits | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, fMRI, CLBP, Pain, Low Back Pain, Back Pain