Auricular Acupuncture Stimulation for Chronic Pain

Not Applicable

Active, not recruiting

• Conditions: Low Back Pain
• Interventions: Other: Stimulation at Location 2; Other: Stimulation at Location 1

• Registration Number: NCT03959111
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-20
• Study First Submitted QC: 2019-05-20
• Study First Posted: 2019-05-22
• Study Start: 2019-10-17
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-09
• Primary Completion: 2023-06-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ear stimulation (Location 2)	Stimulation at Location 2	-
Ear stimulation (Location 1)	Stimulation at Location 1	-

Primary Outcome Measures

Name	Time	Method
Low Back Pain Intensity	4 months	This is a uni-dimensional measure of pain intensity. It uses an 11-point numeric scale. We will use it to measure the patient's average pain intensity in the past week, which will be measured at the beginning and end of the study.

Secondary Outcome Measures

Name	Time	Method
Pain medication dose changes	4 months	Pain medication dose changes as determined by a weekly-collected medication log
Roland-Morris Disability Questionnaire score	4 months	The modified RMDQ is a self-administered disability measure in cLBP patients.
Pain Catastrophizing Scale	4 months	The PCS is a 15-item questionnaire used to characterize an individual's tendency to magnify the threat value of a pain experience and to feel helpless in the presence of pain.
The Pennebaker Inventory of Limbic Languidness	4 months	PILL allows individuals to rate how frequently they have experienced each of 54 common symptoms over an unspecified time period in the past using a five-point Likert scale. The PILL contains a range of physical symptoms, including some items that are pain-related (e.g., headache, back pains, sore muscles).
Patient-Reported Outcomes Measurement Information System (PROMIS) scores	4 months	The PROMIS, funded by the NIH, is a system containing reliable, flexible, precise, and responsive assessment tools that have been widely validated in numerous samples. We will use PROMIS-29 to assess pain interferences and intensity, physical function, depression, anxiety, fatigue, and sleep in the past 7 days.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Charlestown, Massachusetts, United States