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Acupuncture in Traumatic Brain Injury (AccuTBI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369911
Recruitment Status : Not yet recruiting
First Posted : April 30, 2020
Last Update Posted : September 22, 2020
Sponsor:
Collaborator:
Minnesota Office of Higher Education
Information provided by (Responsible Party):
HealthPartners Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Post-traumatic Headache Mild Traumatic Brain Injury Procedure: Acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture Treatment for Chronic Post-traumatic Headache in Individuals With Mild Traumatic Brain Injury
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Dose
Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed.
Procedure: Acupuncture
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.

Experimental: High Dose
Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed.
Procedure: Acupuncture
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 Outcome Measures :
  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 Outcome Measures :
  1. Adverse Events [ Time Frame: 2 years ]
    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.

  3. Compliance with treatment protocol [ Time Frame: 3 months ]
    Completion of treatment duration. Proportion of participants completed the full 30 minutes treatment session. Range: 0-1. A higher proportion indicates more compliance.


Other Outcome Measures:
  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. Range: 10-50. Raw score converted to T-score. Higher score indicates more headache pain.

  3. Change in Headache Duration [ Time Frame: baseline to 3 months ]
    The headache duration, measured in minutes for each headache day. Days will be totaled for the 4 week period measured. Higher number of headache minutes indicates worse headache control.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369911


Contacts
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Contact: Amanda A Herrmann, PhD 651-495-6356 Amanda.A.Herrmann@HealthPartners.com

Locations
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United States, Minnesota
HealthPartners Neuroscience Center
Saint Paul, Minnesota, United States, 55130
Sponsors and Collaborators
HealthPartners Institute
Minnesota Office of Higher Education
Investigators
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Principal Investigator: Amanda A Herrmann, PhD HealthPartners Neuroscience Research
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Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT04369911    
Other Study ID Numbers: A19-094
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HealthPartners Institute:
acupuncture
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Post-Traumatic Headache
Tension-Type Headache
Headache
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Pain
Neurologic Manifestations
Head Injuries, Closed
Wounds, Nonpenetrating
Headache Disorders, Secondary
Headache Disorders
Headache Disorders, Primary