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OpenTrials
Completed

NCT Number: NCT04369911

Acupuncture in Traumatic Brain Injury

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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, or planning to become pregnant during the study
  • Any other medical conditions that could affect their ability to participate in acupuncture treatments for the study duration (as determined by study investigators)
  • Active participation or past participation ≤3 months in any other interventional study.
  • Unwilling to participate in all study related activities

Treatment and study plan

Acupuncture

Procedure

Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.

Primary outcomes

  1. Change in Number of Headache Days

    Time frame: baseline to 3 months

    The number of self-reported headache days over a 4 week period. Range: 0-28 days. More headache total days indicates a worse outcome.

Secondary outcomes

  1. Adverse Events

    Time frame: 16 weeks

    The total number of adverse events (AE) or serious adverse events (SAE) over the course of the study. A higher number of AE/SAEs indicates a less safe treatment.

  2. Compliance With Overall Protocol

    Time frame: 3 months

    Completion of treatment sessions. Percent of target treatments. Range: 0-100. A higher percentage indicates more compliance.

Other outcomes

  1. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 3 months

    The PSQI contains questions about participant's sleeping habits. Range: 0-21. Sum of 7 subscores. Higher score indicates worse sleep quality

  2. Traumatic Brain Injury-Quality of Life Headache Pain (TBI-QOL-Headache)

    Time frame: 3 months

    The TBI-QOL-Headache contains questions about participant's headache pain. Raw Score Range: 10-50. Raw scores converted to T-score (mean = 50, standard deviation = 10). Higher T-score indicates more headache pain.

  3. Change in Headache Pain Intensity

    Time frame: baseline to 3 months

    The headache pain intensity is self reported for each headache day. Pain intensity will be averaged for the 4 week period measured. Pain intensity scale range is 0 (no pain) to 10 (worst pain imaginable). Higher pain intensity score indicates more intense headaches.

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • Minnesota Office of Higher Education

Registry information

Official study title

Acupuncture Treatment for Chronic Post-traumatic Headache in Individuals With Mild Traumatic Brain Injury

Acronym: AccuTBI

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 30, 2020
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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