Acupuncture in Traumatic Brain Injury
Ключові слова
Анотація
Дати
Востаннє перевірено: | 03/31/2020 |
Перший поданий: | 04/27/2020 |
Орієнтовна реєстрація подана: | 04/27/2020 |
Опубліковано вперше: | 04/29/2020 |
Останнє оновлення надіслано: | 07/26/2020 |
Останнє оновлення опубліковано: | 07/28/2020 |
Фактична дата початку навчання: | 07/31/2020 |
Розрахункова дата первинного завершення: | 07/31/2022 |
Розрахункова дата завершення дослідження: | 10/31/2022 |
Стан або захворювання
Втручання / лікування
Procedure: Acupuncture
Фаза
Групи рук
Рука | Втручання / лікування |
---|---|
Experimental: Low Dose Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed. | |
Experimental: High Dose Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed. |
Критерії прийнятності
Вік, придатний для навчання | 18 Years До 18 Years |
Стать, яка підходить для вивчення | All |
Приймає здорових добровольців | Так |
Критерії | 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 |
Результат
Заходи первинного результату
1. Change in number of headache days [baseline to 3 months]
Заходи вторинного результату
1. Adverse Events [2 years]
2. Compliance with overall protocol [3 months]
3. Compliance with treatment protocol [3 months]
Інші результати діяльності
1. Pittsburgh Sleep Quality Index (PSQI) [3 months]
2. Traumatic Brain Injury-Quality of Life Headache Pain (TBI-QOL-Headache) [3 months]
3. Change in Headache Duration [baseline to 3 months]
4. Change in Headache Pain Intensity [baseline to 3 months]