The Impact of Acupuncture on Biomarkers of Brain Injury and Inflammatory Response in Migraine
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- NRS 3
Study Overview
Brief Summary
Migraine is more than just a headache-it can involve changes in the brain and inflammation. Recent research suggests that acupuncture may help by calming pain signals and reducing inflammation in the body. Scientists are studying whether acupuncture can also lower certain markers in the blood that show brain stress or inflammation. While more research is needed, acupuncture is considered safe and may reduce the number and severity of migraine attacks for many people. Acupuncture has been used for over 40 years in our practice to manage acute and chronic pain, including migraines. When performed by trained physicians, it is safe and typically reduces headache frequency and intensity, as well as nausea and vomiting, lowering the need for pain medication.
Investigators are exploring three different ways to help manage migraine headaches using gentle stimulation techniques. These include laser acupuncture, electroacupuncture, and traditional acupuncture.
Investigators want to see which method works best for reducing migraine symptoms. Investigators will look at how participants feel after treatment and also check blood samples for signs of inflammation and certain substances linked to migraines, such as calcitonin gene-related peptide (CGRP) and markers of brain stress.
Investigators have a goal to find safe and effective options that can improve migraine care and help people feel better.
Detailed Description
Investigators are conducting a study to compare three different types of acupuncture treatments. Each participant will be carefully evaluated to meet the requirements for participation. Before joining, each participant will have a conversation with investigators to explain the study and answer any questions.
Participants will be randomly placed into one of three groups:
Traditional Acupuncture - standard acupuncture treatment Electroacupuncture - standard acupuncture combined with gentle electrical stimulation.
Laser Acupuncture - standard acupuncture combined with acupuncture using a low-level laser instead of needles.
After the treatment, Investigators will check in with participants again after 1 and 3 months to see how they are feeling and whether the effects have lasted.Participation is voluntary, with no financial compensation, and care will not be affected by the decision to participate.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adults diagnosed with migraine headaches according to the International Classification of Headache Disorders (ICHD).
- •Patients who are not currently receiving monoclonal antibodies targeting CGRP (Calcitonin Gene-Related Peptide)
- •Ability to provide informed consent and comply with study procedures.
Exclusion Criteria
- •Use of CGRP monoclonal antibody therapy within the past 6 months.
- •Other significant neurological or systemic conditions that could interfere with study outcomes.
- •Pregnancy or breastfeeding.
Outcomes
Primary Outcomes
NRS 3
Time Frame: Baseline and three months from last acupuncture stimulation
Pain intensity three months after treatment measured with NRS (Numeric rate scale) from 0 (for = pain) to 10 (maximal pain)
Secondary Outcomes
- HIT- 6(Baseline and three months from last acupuncture stimulation)
- MIDAS(Baseline and three months from last acupuncture stimulation)
- Biomarkers of brain injury and inflammatory response(Baseline, day of last acupuncture stimulation and three months from last acupuncture stimulation)