Auricular Acupuncture Stimulation for Chronic Pain

Low Back Pain Clinical Trial

Official title:

Auricular Acupuncture Stimulation for Chronic Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03959111
• Other study ID #: 2016P000678
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 17, 2019
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: April 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Low Back Pain

Intervention

Other:
• Stimulation at Location 1
Stimulation parameters will include 1) density wave adjusted to 20Hz with less than 1 ms pulse width, 2) intensity adjusted based on the tolerance of the patient (moderate tolerable stimulation without pain), and 3) treatment will be applied 1 time per day, 5 times per week for four weeks (on-site tVNS treatment plus self-administration at home).
• Stimulation at Location 2
Stimulation parameters will include 1) density wave adjusted to 20Hz with less than 1 ms pulse width, 2) intensity adjusted based on the tolerance of the patient (moderate tolerable stimulation without pain), and 3) treatment will be applied 1 time per day, 5 times per week for four weeks (on-site tVNS treatment plus self-administration at home).

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Charlestown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Resting state functional connectivity changes of the PAG	Functional connectivity changes of the periaqueductal gray while at rest.	1 month
Other	Resting state functional connectivity of the medial and lateral hypothalamus	Functional connectivity changes of the hypothalamus while at rest.	1 month
Other	CBF as measured by ASL	Changes in cerebral blood flow.	1 month
Other	Inflammation biomarkers	Changes in inflammatory biomarker levels	1 month
Primary	Low Back Pain Intensity	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.	4 months
Secondary	Roland-Morris Disability Questionnaire score	The modified RMDQ is a self-administered disability measure in cLBP patients.	4 months
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) scores	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.	4 months
Secondary	Pain medication dose changes	Pain medication dose changes as determined by a weekly-collected medication log	4 months
Secondary	Pain Catastrophizing Scale	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.	4 months
Secondary	The Pennebaker Inventory of Limbic Languidness	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).	4 months