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Auricular Acupuncture for Chronic Lower Back Pain
N/A
Waitlist Available
Led By Jian Kong
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Meet the Classification Criteria of chronic LBP (having low back pain for more than 6 months), as determined by a referring physician
Volunteers 18-65 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
Study Summary
This trialstudies if acupuncture stimulation can help reduce chronic low back pain and may provide a new alternative to opioid painkillers. It could also help us better understand chronic pain.
Who is the study for?
This trial is for adults aged 18-65 with chronic low back pain lasting over 6 months, who have had stable or no treatment in the past month. Participants must understand English well and not be planning surgery during the study. Exclusions include those with certain other pains, severe psychological issues, recent substance abuse disorders, specific causes of back pain like malignancy or spinal stenosis, and conditions that could affect results or make MRI scanning unsafe.Check my eligibility
What is being tested?
The trial tests two types of transcutaneous acupuncture stimulation to treat chronic lower back pain. It aims to find new non-opioid treatments by understanding how nerve stimulation helps relieve pain and what changes occur in the body's response to long-term pain.See study design
What are the potential side effects?
While acupuncture is generally considered safe when performed correctly, potential side effects can include soreness at needle sites, minor bleeding or bruising where needles were inserted, dizziness or fainting. Rarely more serious complications may occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had low back pain for more than 6 months.
Select...
I am between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Low Back Pain Intensity
Secondary outcome measures
Pain Catastrophizing Scale
Pain medication dose changes
Patient-Reported Outcomes Measurement Information System (PROMIS) scores
+2 moreOther outcome measures
CBF as measured by ASL
Inflammation biomarkers
Resting state functional connectivity changes of the PAG
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Ear stimulation (Location 2)Experimental Treatment1 Intervention
Group II: Ear stimulation (Location 1)Experimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,285 Total Patients Enrolled
Jian KongPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
4 Previous Clinical Trials
247 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had low back pain for more than 6 months.My back pain is not due to infections, fractures, cancer, or nerve issues.I have used prescription steroids for pain in the last 6 months.You have a medical condition or implant that makes it unsafe for you to have an MRI scan, or you feel very scared in small spaces or are pregnant.I suffer from headaches or migraines and widespread body pain like fibromyalgia.I do not have severe conditions like fibromyalgia or rheumatoid arthritis.I am between 18 and 65 years old.I have another ongoing pain condition.I plan to have surgery while in the study.I haven't changed my treatment or started any new one in the last month.I have had back surgery or legal issues related to my back condition.You have had problems with drugs or alcohol in the past 2 years.You have any medical conditions, like nerve problems, that might change the results of the QST test.
Research Study Groups:
This trial has the following groups:- Group 1: Ear stimulation (Location 2)
- Group 2: Ear stimulation (Location 1)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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