CompletedNot Applicable

Acupuncture in Traumatic Brain Injury

United States39 participantsStarted 2020-11-23

Plain-language summary

The purpose of the study is to determine the effect of a low vs. high dose of acupuncture treatment in individuals with chronic post-traumatic headache (CPTH). A total of 36 people with mild traumatic brain injury (mTBI) suffering from CPTH will be enrolled in this study to receive acupuncture treatment for 5 weeks. Participants will be randomized into two groups: 1) Low Acupuncture group (5 treatments) and 2) High Acupuncture group (10 treatments). It is hypothesized that both treatment groups will have decreased headaches, but that 10 treatments will greater alleviate headaches when compared to 5 treatments.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Ability to provide and provision of signed and dated informed consent form * Age 18-65 * Diagnosis of mild traumatic brain injury (mTBI) (as defined by the International classification of headache disorders 3rd edition (ICHD-3); a. Either no loss of consciousness, or loss of consciousness of \<30 minutes duration, b. Glascow Coma Scale (GCS) ≥ 13, and c. Symptoms and/or signs diagnostic of concussion) * Diagnosis of mTBI ≥3 months and ≤12 months at the time of study enrollment * Suffering from chronic post-traumatic headache (CPTH) of any etiology (e.g. tension or migraine), with chronic defined as developed within 7 days after injury and lasting ≥3 months from the time of injury * Stable medication regimen for ≥1 months and agree to adhere to his or her current medication treatment regimen through study participation Exclusion Criteria: * Non-English speaking * History of acupuncture since diagnosis of mTBI * History of pre-existing primary headache, defined as more than 12 days of tension-type headache annually and/or more than one migraine attacks per month in the last year * History of any other serious neurological, psychiatric, chronic pain disorders, or seizures * History of bleeding diathesis, other bleeding disorders, or syncope with needle puncture * History of cardiac arrhythmia or current pacemaker, neurostimulator, or other implanted stimulation device * Recent or active substance use disorder * Women who are currently pregnant, lactating…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial looked at acupuncture for chronic headaches after a mild traumatic brain injury — given my specific situation, does my headache pattern look similar enough to what they were studying that the results might be relevant to me?
2The trial measured whether acupuncture reduced the number of headache days per month — do you know what the results showed, and does that kind of improvement seem meaningful compared to my current headache burden?
3Since this trial is already completed and wasn't testing a drug but a therapy like acupuncture, how would I actually access acupuncture as a treatment option now, and would my insurance be likely to cover it?
4Acupuncture is a non-drug approach — before we consider this direction, are there standard medical treatments for post-traumatic headache that I should try first, or would acupuncture be something we'd use alongside those?
5This study was listed as Phase NA, meaning it wasn't a traditional drug trial — does that change how confident you'd be recommending acupuncture based on this kind of evidence, and are there other studies on acupuncture for post-traumatic headache you'd want me to look at?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Number of Headache Days

Timeframe: baseline to 3 months

Trial details

NCT IDNCT04369911

SponsorHealthPartners Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-17

Results submitted2024-11-06

View on ClinicalTrials.gov More Chronic Post-traumatic Headache trials