Clinical trial NCT03959111: Auricular Acupuncture Stimulation for Chronic Pain
Official title: Auricular Acupuncture Stimulation for Chronic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This proposal aims to investigate the treatment effect and underlying mechanism of transcutaneous acupuncture stimulation on chronic low back pain. We believe that this study, if successful, will provide new treatment options for chronic low back pain, reduce the use of opioid analgesics in chronic pain management, and enhance our understanding of the underlying mechanism of nerve stimulation treatment, as well as the pathophysiology and development of chronic pain.


Eligibility criteria: Inclusion Criteria:

* Volunteers 18-65 years of age.
* Meet the Classification Criteria of chronic LBP (having low back pain for more than 6 months), as determined by a referring physician.
* Received stable treatment or no treatment in the past month.
* 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.

Exclusion Criteria:

* Specific causes of back pain (e.g., epidural abscess, compression fracture, spondyloarthropathy, malignancy, cauda equina syndrome) or radicular pain, radiculopathy, or spinal canal stenosis. Complicated back problems (e.g., prior back surgery, medico-legal issues).
* Presence of headache/migraine, as well as widespread body pain such as fibromyalgia.
* The intent to undergo surgery during participation 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 outcomes (e.g., asthma or claustrophobia).
* Presence of any contraindications to MRI scanning (e.g., cardiac pacemaker, metal implants, fear of enclosed spaces, pregnancy, cannot lie still in fMRI scanner).
* Conditions that might confound longitudinal effects or interpretation of results (e.g. severe fibromyalgia, rheumatoid arthritis).
* Pregnant or lactating.
* Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator during Session 1).
* Active substance abuse disorders within the last 24 months (based on subject self-report).
* Use of prescription steroids for pain during the past six months.
* Presence of any other acute or chronic pain disorder.
* Any medical conditions, such as peripheral neuropathy, that could affect the results of QST.

Primary outcomes:
measure: Low Back Pain Intensity
timeFrame: 4 months
Secondary outcomes:
measure: Roland-Morris Disability Questionnaire score
timeFrame: 4 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) scores
timeFrame: 4 months
measure: Pain medication dose changes
timeFrame: 4 months
measure: Pain Catastrophizing Scale
timeFrame: 4 months
measure: The Pennebaker Inventory of Limbic Languidness
timeFrame: 4 months
Other outcomes:
measure: Resting state functional connectivity changes of the PAG
timeFrame: 1 month
measure: Resting state functional connectivity of the medial and lateral hypothalamus
timeFrame: 1 month
measure: CBF as measured by ASL
timeFrame: 1 month
measure: Inflammation biomarkers
timeFrame: 1 month
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jian Kong
role: PRINCIPAL_INVESTIGATOR
References: