Chronic Post-traumatic Headache, Mild Traumatic Brain Injury
Conditions
Keywords
acupuncture
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.
Interventions
PROCEDUREAcupuncture
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.
Sponsors
Minnesota Office of Higher Education
HealthPartners Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Headache Days | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 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. |
| Compliance With Overall Protocol | 3 months | Completion of treatment sessions. Percent of target treatments. Range: 0-100. A higher percentage indicates more compliance. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | 3 months | The PSQI contains questions about participant's sleeping habits. Range: 0-21. Sum of 7 subscores. Higher score indicates worse sleep quality |
| Traumatic Brain Injury-Quality of Life Headache Pain (TBI-QOL-Headache) | 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. |
| Change in Headache Pain Intensity | 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. |
Countries
United States
Participant flow
Pre-assignment details
One participant was withdrawn for eligibility reasons prior to randomization to study group. This participant was not included in analysis.
Participants by arm
| Arm | Count |
|---|---|
| Low Dose Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed.
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. | 18 |
| High Dose Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed.
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. | 20 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Total | Low Dose | High Dose |
|---|---|---|---|
| Age, Categorical <=18 years | 8 Participants | 5 Participants | 3 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 12 Participants | 17 Participants |
| Age, Continuous | 45 years STANDARD_DEVIATION 13 | 44 years STANDARD_DEVIATION 14 | 47 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 17 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 29 Participants | 12 Participants | 17 Participants |
| Sex: Female, Male Female | 29 Participants | 14 Participants | 15 Participants |
| Sex: Female, Male Male | 9 Participants | 4 Participants | 5 Participants |
| Time to diagnosis of TBI | 7.7 months | 7.5 months | 8.9 months |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 20 |
| other Total, other adverse events | 14 / 18 | 17 / 20 |
| serious Total, serious adverse events | 0 / 18 | 0 / 20 |
Outcome results
Primary
Change in Number of Headache Days
The number of self-reported headache days over a 4 week period. Range: 0-28 days. More headache total days indicates a worse outcome.
Time frame: baseline to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Dose | Change in Number of Headache Days | -8 headache days | Standard Deviation 10 |
| High Dose | Change in Number of Headache Days | -6 headache days | Standard Deviation 8 |
Secondary
Adverse Events
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.
Time frame: 16 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Dose | Adverse Events | 13 total number of AEs |
| High Dose | Adverse Events | 25 total number of AEs |
Secondary
Compliance With Overall Protocol
Completion of treatment sessions. Percent of target treatments. Range: 0-100. A higher percentage indicates more compliance.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Dose | Compliance With Overall Protocol | 95 percentage of treatments completed | Standard Deviation 19 |
| High Dose | Compliance With Overall Protocol | 91 percentage of treatments completed | Standard Deviation 27 |
Other Pre-specified
Change in Headache Pain Intensity
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.
Time frame: baseline to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Dose | Change in Headache Pain Intensity | -.57 score on a scale | Standard Deviation 0.74 |
| High Dose | Change in Headache Pain Intensity | -.20 score on a scale | Standard Deviation 1.09 |
Other Pre-specified
Pittsburgh Sleep Quality Index (PSQI)
The PSQI contains questions about participant's sleeping habits. Range: 0-21. Sum of 7 subscores. Higher score indicates worse sleep quality
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Dose | Pittsburgh Sleep Quality Index (PSQI) | 9.9 score on a scale | Standard Deviation 5 |
| High Dose | Pittsburgh Sleep Quality Index (PSQI) | 9.1 score on a scale | Standard Deviation 3.4 |
Other Pre-specified
Traumatic Brain Injury-Quality of Life Headache Pain (TBI-QOL-Headache)
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Dose | Traumatic Brain Injury-Quality of Life Headache Pain (TBI-QOL-Headache) | 59 T-score | Standard Deviation 5 |
| High Dose | Traumatic Brain Injury-Quality of Life Headache Pain (TBI-QOL-Headache) | 58 T-score | Standard Deviation 6 |