PTSDNCT05516862
Determining the Right Acupuncture for Good Recovery Over Neuropsychiatric Trauma
A study testing Dragons acupuncture and Dragons acupressure in people with PTSD and Post Traumatic Stress Disorder, run by Paul Crawford at 1 site in United States.
Trial summary
This study seeks to verify that a specific acupuncture treatment is effective at reducing symptoms of neuropsychiatric trauma found in those diagnosed with Post-Traumatic Stress Disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- PTSD, Post Traumatic Stress Disorder, Acupuncture
- What is being tested?
- Dragons acupuncture and Dragons acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active Duty members and DoD beneficiaries(i.e. former military, spouse, dependent child), 18-65 years old
- Meeting the criteria for PTSD based on PCL-5 (past month scores) score of 31 or higher
- At least 1 positive response to at least one item on the LEC-5.
Who cannot join
- Pregnant, may be pregnant, or attempting to become pregnant. There areno known risks of this acupuncture in pregnant patients; however, we will exclude pregnancy due to the location of the needles (right over the uterus in 3rd trimester) and risk of exacerbating anxiety that may cause stress on the baby. Subjects will be told to let us know if they become pregnant so we can disenroll them from the study.
- Prior treatment with Dragons acupuncture
- History of hospitalization for mental health reasons within the last year
- Active Suicidal thoughts (is currently considering suicide or has a plan) or suicide attempt within the last year. This will be assessed by direct questioning.
- Is currently receiving acupuncture or other non-medication treatments specifically for PTSD (patients can elect to forgo PTSD treatments during the study period and then resume after the study period is over; ie halt therapy during the study period)
- Legally Authorized Representatives will not be utilized in this study
- Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Mike O'Callaghan Military Medical Center
Nellis Air Force Base, Nevada, 89191
About this study
Official title: Determining the Right Acupuncture for Good Recovery Over Neuropsychiatric Trauma (DRAGON)
This study seeks to verify that a specific acupuncture treatment is effective at reducing symptoms of neuropsychiatric trauma found in those diagnosed with Post-Traumatic Stress Disorder (PTSD).
Read the detailed description
Traumatic stress experienced by service members negatively affects their ability to psychologically and emotionally cope with operational and family stressors. Physically, chronic pain complaints are higher in those with neuropsychiatric trauma. These can lead to a decrease in quality and duration of life. The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) classifies Post-Traumatic Stress Disorder as an anxiety disorder (DSM). To achieve this diagnosis a person must be exposed to a traumatic event and then experience long lasting intrusive symptoms such as nightmares, irritability, flashbacks and trauma related thoughts or feelings that impair their ability to function in their day-to-day activities. These symptoms can be very distressing to individuals, often leading to other mental health disorders such as depression and generalized anxiety. They also frequently have widespread negative effects on their families, friends, co-workers and ultimately the mission of the United States Military. A leading theory regarding the underlying cause of PTSD states that the sympathetic nervous system (fight or flight) is upregulated every time the emotional centers of the brain are reminded of the traumatic event. This upregulation causes symptoms listed above along with physiologic symptoms such as elevations in heart rate, breathing and blood pressure. This can occur even in the absence of the conscious mind recognizing what is triggering this sympathetic response1.
The overall effect for a patient is the overwhelming feeling that a terrifying traumatic event experienced many years ago is happening again in the present. Treatments aimed at downregulation of the sympathetic nervous system are common; however, treatments that can "break" the connection between prior trauma, the emotional centers of the brain and the sympathetic nervous system have the potential to treat the true underlying cause of PTSD.
Treatment of psychological, emotional, and physical symptoms of Post-Traumatic Stress Disorder (PTSD) can include medication, psychotherapy, or some combination of the two. Evidence supports the idea that receiving traditional treatment for PTSD symptoms such as psychotherapy is something that many veterans are disinclined to do due to a perceived stigma of admitting that they have a mental illness (Mittal); although when adhered to, psychotherapy can cause significant improvement in PTSD symptoms such as sleep disturbance, depression, and suicidality 2. Alternatives to these traditional therapies are needed.
Compared to traditional CBT, acupuncture offers a treatment effect for PTSD similar to CBT (Hollifield)6. A systematic review and meta-analysis examining prospective controlled clinical trials found no statistical difference between acupuncture and CBT (Kim)7. Compared to traditional SSRIs, acupuncture may be a treatment option for those experiencing SSRI side effects of sexual dysfunction, weight gain, and sleep disturbance (Kim)7. One part of Acupuncturists Without Borders (AWB) reports that veterans given acupuncture for PTSD reported better sleep with fewer nightmares, a clearer mental state, and less stress (Sneizck)8. Auricular (ear) acupuncture treatments in the veteran and servicemember population diagnosed with PTSD found that those treated had improved sleep, increased relaxation, decreased pain, and improvements in depression symptoms (Huang; Engel; King)9,10,11.
Veterans also reacted favorably to the concept of the brief course of auricular acupuncture treatments, especially those who had avoided PTSD treatment due to associated stigma or lack of faith in traditional methods (King)11.
There is an urgent need for additional, empirically validated, non-opioid alternative strategies attached to less stigma for symptoms associated with PTSD. Programs across the United States military are showing the effect of integrative medicine approaches, and this study will serve as another building block in the emerging whole person approach to military medicine12.
One path to successful PTSD treatments may involve the vagal nerve. The vagal nerve is responsible for connecting the brain's central functions with peripheral organ function all throughout the body and counteracts the sympathetic response ( creating a rest and digest response)13. It regulates the body's stress response; dysregulation of the vagus-controlled hypothalamic-pituitary-adrenal axis is connected to PTSD14. Accordingly, external stimulus to the vagal nerve could forcefully alleviate dysregulation15. Historically, vagal nerve stimulation was achieved through surgical device implantation. Noninvasive vagal nerve stimulation methods are being newly developed and can positively affect a variety of physiologic processes (Bremner)13.
We suggest that our acupuncture protocol is another novel method that can stimulate parts of the vagal nerve.
MicroRNA biomarkers for posttraumatic stress disorder: MicroRNAs (miRNAs, miRs) are small RNA molecules (~ 22 nucleotides long) and are often, but need not be, post-transcriptional regulators that bind to complementary sequences on target messenger RNA transcripts (mRNA), usually resulting in translational repression and gene silencing. MiRNA may serve as good biomarkers because they are highly stable in serum due to their ability to withstand repeated freeze thaw, enzymatic degradation, and extreme pH conditions.
- Conditions
- PTSD, Post Traumatic Stress Disorder, Acupuncture
- Being tested
- Dragons acupuncture, Dragons acupressure, Dragons placebo
- Keywords
- PTSD, DRAGONS, family medicine residency
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dragons acupunctureOther
The treatment we are studying is supposed to help the rational and emotional brain effectively communicate, so that the emotional brain can finally realize the trauma experienced is no longer a threat. We call this re-processing. It does not take away the memory but it allows the rational brain to see the memory as just a memory without the emotional brain initiating your fight, flight or freeze system. This allows the mind to take the file off the messy desk and put it away. The treatment was named by the Chinese and is called "External and Internal Dragons". According to the Chinese, the External Dragons represent all the bad (traumatic) things that happen to us. The Internal Dragons live inside us, and fight off the External Dragons.
Subject will lay on your stomach and have 7 needles placed in head, upper back, lower back and ankles.
Dragons acupressureOther
The treatment we are studying is supposed to help the rational and emotional brain effectively communicate, so that the emotional brain can finally realize the trauma experienced is no longer a threat. We call this re-processing. It does not take away the memory but it allows the rational brain to see the memory as just a memory without the emotional brain initiating your fight, flight or freeze system. This allows the mind to take the file off the messy desk and put it away. The treatment was named by the Chinese and is called "External and Internal Dragons". According to the Chinese, the External Dragons represent all the bad (traumatic) things that happen to us. The Internal Dragons live inside us, and fight off the External Dragons.
Subject will lay on your stomach and have 7 small acupressure adhesive bandages placed on head, upper back, lower back and ankles.
Dragons placeboOther
The treatment we are studying is supposed to help the rational and emotional brain effectively communicate, so that the emotional brain can finally realize the trauma experienced is no longer a threat. We call this re-processing. It does not take away the memory but it allows the rational brain to see the memory as just a memory without the emotional brain initiating your fight, flight or freeze system. This allows the mind to take the file off the messy desk and put it away. The treatment was named by the Chinese and is called "External and Internal Dragons". According to the Chinese, the External Dragons represent all the bad (traumatic) things that happen to us. The Internal Dragons live inside us, and fight off the External Dragons.
Subject will lay on your stomach and the doctor will touch 7 points on head, upper back, lower back and ankles.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Script followed by Dragons Acupuncture (external Dragons points with patient prone for 15 minutes followed by internal Dragons points with patient supine for 15 minutes). Receives: Other: Dragons acupuncture |
| Group 2 | Sham comparator | Script followed by Dragons sham acupressure placed at the Dragons points (external Dragons points with patient prone for 15 minutes followed by internal Dragons points with patient supine for 15 minutes). Receives: Other: Dragons acupressure |
| Group 3 | Placebo comparator | Script followed by Acupuncturist lightly touching Dragons points (external Dragons points with patient prone for 15 minutes followed by internal Dragons points with patient supine for 15 minutes). Receives: Other: Dragons placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
The CAPS-5 is a structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The CAPS-5 will be applied for its first purpose in this study. The instrument produces a total symptom severity score by summing severity scores for the 20 DSM-5 PTSD symptoms and symptom cluster severity scores calculated by summing individual item severity scores for symptoms corresponding to a given DSM-5 cluster. There are five symptom cluster severity scores: Criterion B, Criterion C, Criterion D, Criterion E and Criterion disassociation.
Measured: visit 1 (week 0)
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
The CAPS-5 is a structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The CAPS-5 will be applied for its first purpose in this study. The instrument produces a total symptom severity score by summing severity scores for the 20 DSM-5 PTSD symptoms and symptom cluster severity scores calculated by summing individual item severity scores for symptoms corresponding to a given DSM-5 cluster. There are five symptom cluster severity scores: Criterion B, Criterion C, Criterion D, Criterion E and Criterion disassociation.
Measured: visit 6 (week 8)
PTSD checklist for DSM-5 (PCL-5)
PCL-5 is a 20-item self-reporting measure of PTSD rating how the respondent has been bothered by PTSD symptoms over the past month using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Responses are summed to a total score with higher scores indicate greater PTSD symptom severity. A total symptom severity score (range 0 - 80) can be obtained by summing the scores for each of the 20 items. Research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD. A 5 - 10 point change represents reliable change (i.e., change not due to chance) and a 10 - 20 point change represents clinically significant change.
Measured: visit 1 (week 0)
PTSD checklist for DSM-5 (PCL-5)
PCL-5 is a 20-item self-reporting measure of PTSD rating how the respondent has been bothered by PTSD symptoms over the past month using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Responses are summed to a total score with higher scores indicate greater PTSD symptom severity. A total symptom severity score (range 0 - 80) can be obtained by summing the scores for each of the 20 items. Research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD. A 5 - 10 point change represents reliable change (i.e., change not due to chance) and a 10 - 20 point change represents clinically significant change.
Measured: visit 3 (week 2)
PTSD checklist for DSM-5 (PCL-5)
PCL-5 is a 20-item self-reporting measure of PTSD rating how the respondent has been bothered by PTSD symptoms over the past month using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Responses are summed to a total score with higher scores indicate greater PTSD symptom severity. A total symptom severity score (range 0 - 80) can be obtained by summing the scores for each of the 20 items. Research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD. A 5 - 10 point change represents reliable change (i.e., change not due to chance) and a 10 - 20 point change represents clinically significant change.
Measured: visit 4 (week 3)
PTSD checklist for DSM-5 (PCL-5)
PCL-5 is a 20-item self-reporting measure of PTSD rating how the respondent has been bothered by PTSD symptoms over the past month using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Responses are summed to a total score with higher scores indicate greater PTSD symptom severity. A total symptom severity score (range 0 - 80) can be obtained by summing the scores for each of the 20 items. Research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD. A 5 - 10 point change represents reliable change (i.e., change not due to chance) and a 10 - 20 point change represents clinically significant change.
Measured: visit 5 (week 4)
PTSD checklist for DSM-5 (PCL-5)
PCL-5 is a 20-item self-reporting measure of PTSD rating how the respondent has been bothered by PTSD symptoms over the past month using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Responses are summed to a total score with higher scores indicate greater PTSD symptom severity. A total symptom severity score (range 0 - 80) can be obtained by summing the scores for each of the 20 items. Research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD. A 5 - 10 point change represents reliable change (i.e., change not due to chance) and a 10 - 20 point change represents clinically significant change.
Measured: visit 6 (week 8)
Secondary outcomes (2)
microRNA biomarkers
Changes in microRNA (miRNA) serum biomarkers miRNA-518f-3p, miRNA-486-5p, miRNA-let-7b, miRNA-220, and miRNA-433.
Measured: visit 1 (week 0)
microRNA biomarkers
Changes in microRNA (miRNA) serum biomarkers miRNA-518f-3p, miRNA-486-5p, miRNA-let-7b, miRNA-220, and miRNA-433.
Measured: visit 6 (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start1 Oct 2022
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paul Crawford
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, Paul Crawford, Mike O'Callaghan Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516862
- Sponsor's protocol ID
- USUHS.2022-101
- Status last verified
- Oct 2026
- First submitted
- 24 Aug 2022
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan on sharing data.
Publications
Van, K. B. A. (2014). The body keeps the score: Brain, mind, and body in the healing of trauma. p 44-46
Vitale A, Byma L, Sun S, Podolak E, Wang Z, Alter S, Galfalvy H, Geraci J, Langhoff E, Klingbeil H, Yehuda R, Haghighi F, Feder A. Effectiveness of Complementary and Integrative Approaches in Promoting Engagement and Overall Wellness Toward Suicide Prevention in Veterans. J Altern Complement Med. 2021 Mar;27(S1):S14-S27. doi: 10.1089/acm.2020.0245.
PubMed 33788604Jiang Y, Hao Y, Zhang Y, Liu J, Wang X, Han J, Fang J, Zhang J, Cui C. Thirty minute transcutaneous electric acupoint stimulation modulates resting state brain activities: a perfusion and BOLD fMRI study. Brain Res. 2012 May 31;1457:13-25. doi: 10.1016/j.brainres.2012.03.063. Epub 2012 Apr 3.
PubMed 22541167Xiang XH, Chen YM, Zhang JM, Tian JH, Han JS, Cui CL. Low- and high-frequency transcutaneous electrical acupoint stimulation induces different effects on cerebral mu-opioid receptor availability in rhesus monkeys. J Neurosci Res. 2014 May;92(5):555-63. doi: 10.1002/jnr.23351. Epub 2014 Jan 31.
PubMed 24482187Feng B, Zhang Y, Luo LY, Wu JY, Yang SJ, Zhang N, Tan QR, Wang HN, Ge N, Ning F, Zheng ZL, Zhu RM, Qian MC, Chen ZY, Zhang ZJ. Transcutaneous electrical acupoint stimulation for post-traumatic stress disorder: Assessor-blinded, randomized controlled study. Psychiatry Clin Neurosci. 2019 Apr;73(4):179-186. doi: 10.1111/pcn.12810. Epub 2019 Jan 22.
PubMed 30565342Hollifield M. Acupuncture for posttraumatic stress disorder: conceptual, clinical, and biological data support further research. CNS Neurosci Ther. 2011 Dec;17(6):769-79. doi: 10.1111/j.1755-5949.2011.00241.x. Epub 2011 Feb 26.
PubMed 22070661Kim YD, Heo I, Shin BC, Crawford C, Kang HW, Lim JH. Acupuncture for posttraumatic stress disorder: a systematic review of randomized controlled trials and prospective clinical trials. Evid Based Complement Alternat Med. 2013;2013:615857. doi: 10.1155/2013/615857. Epub 2013 Feb 6.
PubMed 23476697Sniezek DP. Community-Based Wounded Warrior Sustainability Initiative (CBWSI): an integrative medicine strategy for mitigating the effects of PTSD. J Rehabil Res Dev. 2012;49(3):ix-xix. doi: 10.1682/jrrd.2012.02.0025. No abstract available.
PubMed 22773206Huang W, Johnson TM, Kutner NG, Halpin SN, Weiss P, Griffiths PC, Bliwise DL. Acupuncture for Treatment of Persistent Disturbed Sleep: A Randomized Clinical Trial in Veterans With Mild Traumatic Brain Injury and Posttraumatic Stress Disorder. J Clin Psychiatry. 2018 Dec 11;80(1):18m12235. doi: 10.4088/JCP.18m12235.
PubMed 30549498Engel CC, Cordova EH, Benedek DM, Liu X, Gore KL, Goertz C, Freed MC, Crawford C, Jonas WB, Ursano RJ. Randomized effectiveness trial of a brief course of acupuncture for posttraumatic stress disorder. Med Care. 2014 Dec;52(12 Suppl 5):S57-64. doi: 10.1097/MLR.0000000000000237.
PubMed 25397825King CH, Moore LC, Spence CD. Exploring Self-Reported Benefits of Auricular Acupuncture Among Veterans With Posttraumatic Stress Disorder. J Holist Nurs. 2016 Sep;34(3):291-9. doi: 10.1177/0898010115610050. Epub 2015 Nov 3.
PubMed 26530240Hull A, Brooks Holliday S, Eickhoff C, Sullivan P, Courtney R, Sossin K, Adams A, Reinhard M. Veteran participation in the integrative health and wellness program: Impact on self-reported mental and physical health outcomes. Psychol Serv. 2019 Aug;16(3):475-483. doi: 10.1037/ser0000192. Epub 2018 Apr 5.
PubMed 29620393Bremner JD, Gurel NZ, Wittbrodt MT, Shandhi MH, Rapaport MH, Nye JA, Pearce BD, Vaccarino V, Shah AJ, Park J, Bikson M, Inan OT. Application of Noninvasive Vagal Nerve Stimulation to Stress-Related Psychiatric Disorders. J Pers Med. 2020 Sep 9;10(3):119. doi: 10.3390/jpm10030119.
PubMed 32916852de Kloet CS, Vermetten E, Geuze E, Kavelaars A, Heijnen CJ, Westenberg HG. Assessment of HPA-axis function in posttraumatic stress disorder: pharmacological and non-pharmacological challenge tests, a review. J Psychiatr Res. 2006 Sep;40(6):550-67. doi: 10.1016/j.jpsychires.2005.08.002. Epub 2005 Oct 7.
PubMed 16214171Thrivikraman KV, Zejnelovic F, Bonsall RW, Owens MJ. Neuroendocrine homeostasis after vagus nerve stimulation in rats. Psychoneuroendocrinology. 2013 Jul;38(7):1067-77. doi: 10.1016/j.psyneuen.2012.10.015. Epub 2012 Nov 16.
PubMed 23159723
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Right Acupuncture for Good Recovery Over Neuropsychiatric Trauma (DRAGON)
- ClinicalTrials.gov ID
- NCT05516862
- Acronym / sponsor ID
- USUHS.2022-101
- Conditions
- PTSD, Post Traumatic Stress Disorder, Acupuncture
- Keywords
- PTSD, DRAGONS, family medicine residency
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Paul CrawfordUS federal agency
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to verify that a specific acupuncture treatment is effective at reducing symptoms of neuropsychiatric trauma found in those diagnosed with Post-Traumatic Stress Disorder (PTSD).
Detailed description
Traumatic stress experienced by service members negatively affects their ability to psychologically and emotionally cope with operational and family stressors. Physically, chronic pain complaints are higher in those with neuropsychiatric trauma. These can lead to a decrease in quality and duration of life. The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) classifies Post-Traumatic Stress Disorder as an anxiety disorder (DSM). To achieve this diagnosis a person must be exposed to a traumatic event and then experience long lasting intrusive symptoms such as nightmares, irritability, flashbacks and trauma related thoughts or feelings that impair their ability to function in their day-to-day activities. These symptoms can be very distressing to individuals, often leading to other mental health disorders such as depression and generalized anxiety. They also frequently have widespread negative effects on their families, friends, co-workers and ultimately the mission of the United States Military. A leading theory regarding the underlying cause of PTSD states that the sympathetic nervous system (fight or flight) is upregulated every time the emotional centers of the brain are reminded of the traumatic event. This upregulation causes symptoms listed above along with physiologic symptoms such as elevations in heart rate, breathing and blood pressure. This can occur even in the absence of the conscious mind recognizing what is triggering this sympathetic response1.
The overall effect for a patient is the overwhelming feeling that a terrifying traumatic event experienced many years ago is happening again in the present. Treatments aimed at downregulation of the sympathetic nervous system are common; however, treatments that can "break" the connection between prior trauma, the emotional centers of the brain and the sympathetic nervous system have the potential to treat the true underlying cause of PTSD.
Treatment of psychological, emotional, and physical symptoms of Post-Traumatic Stress Disorder (PTSD) can include medication, psychotherapy, or some combination of the two. Evidence supports the idea that receiving traditional treatment for PTSD symptoms such as psychotherapy is something that many veterans are disinclined to do due to a perceived stigma of admitting that they have a mental illness (Mittal); although when adhered to, psychotherapy can cause significant improvement in PTSD symptoms such as sleep disturbance, depression, and suicidality 2. Alternatives to these traditional therapies are needed.
Compared to traditional CBT, acupuncture offers a treatment effect for PTSD similar to CBT (Hollifield)6. A systematic review and meta-analysis examining prospective controlled clinical trials found no statistical difference between acupuncture and CBT (Kim)7. Compared to traditional SSRIs, acupuncture may be a treatment option for those experiencing SSRI side effects of sexual dysfunction, weight gain, and sleep disturbance (Kim)7. One part of Acupuncturists Without Borders (AWB) reports that veterans given acupuncture for PTSD reported better sleep with fewer nightmares, a clearer mental state, and less stress (Sneizck)8. Auricular (ear) acupuncture treatments in the veteran and servicemember population diagnosed with PTSD found that those treated had improved sleep, increased relaxation, decreased pain, and improvements in depression symptoms (Huang; Engel; King)9,10,11.
Veterans also reacted favorably to the concept of the brief course of auricular acupuncture treatments, especially those who had avoided PTSD treatment due to associated stigma or lack of faith in traditional methods (King)11.
There is an urgent need for additional, empirically validated, non-opioid alternative strategies attached to less stigma for symptoms associated with PTSD. Programs across the United States military are showing the effect of integrative medicine approaches, and this study will serve as another building block in the emerging whole person approach to military medicine12.
One path to successful PTSD treatments may involve the vagal nerve. The vagal nerve is responsible for connecting the brain's central functions with peripheral organ function all throughout the body and counteracts the sympathetic response ( creating a rest and digest response)13. It regulates the body's stress response; dysregulation of the vagus-controlled hypothalamic-pituitary-adrenal axis is connected to PTSD14. Accordingly, external stimulus to the vagal nerve could forcefully alleviate dysregulation15. Historically, vagal nerve stimulation was achieved through surgical device implantation. Noninvasive vagal nerve stimulation methods are being newly developed and can positively affect a variety of physiologic processes (Bremner)13.
We suggest that our acupuncture protocol is another novel method that can stimulate parts of the vagal nerve.
MicroRNA biomarkers for posttraumatic stress disorder: MicroRNAs (miRNAs, miRs) are small RNA molecules (~ 22 nucleotides long) and are often, but need not be, post-transcriptional regulators that bind to complementary sequences on target messenger RNA transcripts (mRNA), usually resulting in translational repression and gene silencing. MiRNA may serve as good biomarkers because they are highly stable in serum due to their ability to withstand repeated freeze thaw, enzymatic degradation, and extreme pH conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Dragons acupunctureScript followed by Dragons Acupuncture (external Dragons points with patient prone for 15 minutes followed by internal Dragons points with patient supine for 15 minutes). |
| Group 2 | Sham comparator | Other: Dragons acupressureScript followed by Dragons sham acupressure placed at the Dragons points (external Dragons points with patient prone for 15 minutes followed by internal Dragons points with patient supine for 15 minutes). |
| Group 3 | Placebo comparator | Other: Dragons placeboScript followed by Acupuncturist lightly touching Dragons points (external Dragons points with patient prone for 15 minutes followed by internal Dragons points with patient supine for 15 minutes). |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Active Duty members and DoD beneficiaries(i.e. former military, spouse, dependent child), 18-65 years old
- Meeting the criteria for PTSD based on PCL-5 (past month scores) score of 31 or higher
- At least 1 positive response to at least one item on the LEC-5.
Key exclusion criteria (7 listed)
- Pregnant, may be pregnant, or attempting to become pregnant. There areno known risks of this acupuncture in pregnant patients; however, we will exclude pregnancy due to the location of the needles (right over the uterus in 3rd trimester) and risk of exacerbating anxiety that may cause stress on the baby. Subjects will be told to let us know if they become pregnant so we can disenroll them from the study.
- Prior treatment with Dragons acupuncture
- History of hospitalization for mental health reasons within the last year
- Active Suicidal thoughts (is currently considering suicide or has a plan) or suicide attempt within the last year. This will be assessed by direct questioning.
- Is currently receiving acupuncture or other non-medication treatments specifically for PTSD (patients can elect to forgo PTSD treatments during the study period and then resume after the study period is over; ie halt therapy during the study period)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dragons acupunctureThe treatment we are studying is supposed to help the rational and emotional brain effectively communicate, so that the emotional brain can finally realize the trauma experienced is no longer a threat. We call this re-processing. It does not take away the memory but it allows the rational brain to see the memory as just a memory without the emotional brain initiating your fight, flight or freeze system. This allows the mind to take the file off the messy desk and put it away. The treatment was named by the Chinese and is called "External and Internal Dragons". According to the Chinese, the External Dragons represent all the bad (traumatic) things that happen to us. The Internal Dragons live inside us, and fight off the External Dragons. Subject will lay on your stomach and have 7 needles placed in head, upper back, lower back and ankles. | Other | Group 1 |
| Dragons acupressureThe treatment we are studying is supposed to help the rational and emotional brain effectively communicate, so that the emotional brain can finally realize the trauma experienced is no longer a threat. We call this re-processing. It does not take away the memory but it allows the rational brain to see the memory as just a memory without the emotional brain initiating your fight, flight or freeze system. This allows the mind to take the file off the messy desk and put it away. The treatment was named by the Chinese and is called "External and Internal Dragons". According to the Chinese, the External Dragons represent all the bad (traumatic) things that happen to us. The Internal Dragons live inside us, and fight off the External Dragons. Subject will lay on your stomach and have 7 small acupressure adhesive bandages placed on head, upper back, lower back and ankles. | Other | Group 2 |
| Dragons placeboThe treatment we are studying is supposed to help the rational and emotional brain effectively communicate, so that the emotional brain can finally realize the trauma experienced is no longer a threat. We call this re-processing. It does not take away the memory but it allows the rational brain to see the memory as just a memory without the emotional brain initiating your fight, flight or freeze system. This allows the mind to take the file off the messy desk and put it away. The treatment was named by the Chinese and is called "External and Internal Dragons". According to the Chinese, the External Dragons represent all the bad (traumatic) things that happen to us. The Internal Dragons live inside us, and fight off the External Dragons. Subject will lay on your stomach and the doctor will touch 7 points on head, upper back, lower back and ankles. | Other | Group 3 |
Primary outcome
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: visit 1 (week 0)
The CAPS-5 is a structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The CAPS-5 will be applied for its first purpose in this study. The instrument produces a total symptom severity score by summing severity scores for the 20 DSM-5 PTSD symptoms and symptom cluster severity scores calculated by summing individual item severity scores for symptoms corresponding to a given DSM-5 cluster. There are five symptom cluster severity scores: Criterion B, Criterion C, Criterion D, Criterion E and Criterion disassociation.
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: visit 6 (week 8)
The CAPS-5 is a structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The CAPS-5 will be applied for its first purpose in this study. The instrument produces a total symptom severity score by summing severity scores for the 20 DSM-5 PTSD symptoms and symptom cluster severity scores calculated by summing individual item severity scores for symptoms corresponding to a given DSM-5 cluster. There are five symptom cluster severity scores: Criterion B, Criterion C, Criterion D, Criterion E and Criterion disassociation.
PTSD checklist for DSM-5 (PCL-5)
Time frame: visit 1 (week 0)
PCL-5 is a 20-item self-reporting measure of PTSD rating how the respondent has been bothered by PTSD symptoms over the past month using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Responses are summed to a total score with higher scores indicate greater PTSD symptom severity. A total symptom severity score (range 0 - 80) can be obtained by summing the scores for each of the 20 items. Research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD. A 5 - 10 point change represents reliable change (i.e., change not due to chance) and a 10 - 20 point change represents clinically significant change.
PTSD checklist for DSM-5 (PCL-5)
Time frame: visit 3 (week 2)
PCL-5 is a 20-item self-reporting measure of PTSD rating how the respondent has been bothered by PTSD symptoms over the past month using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Responses are summed to a total score with higher scores indicate greater PTSD symptom severity. A total symptom severity score (range 0 - 80) can be obtained by summing the scores for each of the 20 items. Research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD. A 5 - 10 point change represents reliable change (i.e., change not due to chance) and a 10 - 20 point change represents clinically significant change.
PTSD checklist for DSM-5 (PCL-5)
Time frame: visit 4 (week 3)
PCL-5 is a 20-item self-reporting measure of PTSD rating how the respondent has been bothered by PTSD symptoms over the past month using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Responses are summed to a total score with higher scores indicate greater PTSD symptom severity. A total symptom severity score (range 0 - 80) can be obtained by summing the scores for each of the 20 items. Research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD. A 5 - 10 point change represents reliable change (i.e., change not due to chance) and a 10 - 20 point change represents clinically significant change.
PTSD checklist for DSM-5 (PCL-5)
Time frame: visit 5 (week 4)
PCL-5 is a 20-item self-reporting measure of PTSD rating how the respondent has been bothered by PTSD symptoms over the past month using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Responses are summed to a total score with higher scores indicate greater PTSD symptom severity. A total symptom severity score (range 0 - 80) can be obtained by summing the scores for each of the 20 items. Research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD. A 5 - 10 point change represents reliable change (i.e., change not due to chance) and a 10 - 20 point change represents clinically significant change.
PTSD checklist for DSM-5 (PCL-5)
Time frame: visit 6 (week 8)
PCL-5 is a 20-item self-reporting measure of PTSD rating how the respondent has been bothered by PTSD symptoms over the past month using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Responses are summed to a total score with higher scores indicate greater PTSD symptom severity. A total symptom severity score (range 0 - 80) can be obtained by summing the scores for each of the 20 items. Research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD. A 5 - 10 point change represents reliable change (i.e., change not due to chance) and a 10 - 20 point change represents clinically significant change.
2 secondary outcomes
microRNA biomarkers
Time frame: visit 1 (week 0)
microRNA biomarkers
Time frame: visit 6 (week 8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- BackgroundVan, K. B. A. (2014). The body keeps the score: Brain, mind, and body in the healing of trauma. p 44-46
- Background: PubMed 33788604Vitale A, Byma L, Sun S, Podolak E, Wang Z, Alter S, Galfalvy H, Geraci J, Langhoff E, Klingbeil H, Yehuda R, Haghighi F, Feder A. Effectiveness of Complementary and Integrative Approaches in Promoting Engagement and Overall Wellness Toward Suicide Prevention in Veterans. J Altern Complement Med. 2021 Mar;27(S1):S14-S27. doi: 10.1089/acm.2020.0245.
- Background: PubMed 22541167Jiang Y, Hao Y, Zhang Y, Liu J, Wang X, Han J, Fang J, Zhang J, Cui C. Thirty minute transcutaneous electric acupoint stimulation modulates resting state brain activities: a perfusion and BOLD fMRI study. Brain Res. 2012 May 31;1457:13-25. doi: 10.1016/j.brainres.2012.03.063. Epub 2012 Apr 3.
- Background: PubMed 24482187Xiang XH, Chen YM, Zhang JM, Tian JH, Han JS, Cui CL. Low- and high-frequency transcutaneous electrical acupoint stimulation induces different effects on cerebral mu-opioid receptor availability in rhesus monkeys. J Neurosci Res. 2014 May;92(5):555-63. doi: 10.1002/jnr.23351. Epub 2014 Jan 31.
- Background: PubMed 30565342Feng B, Zhang Y, Luo LY, Wu JY, Yang SJ, Zhang N, Tan QR, Wang HN, Ge N, Ning F, Zheng ZL, Zhu RM, Qian MC, Chen ZY, Zhang ZJ. Transcutaneous electrical acupoint stimulation for post-traumatic stress disorder: Assessor-blinded, randomized controlled study. Psychiatry Clin Neurosci. 2019 Apr;73(4):179-186. doi: 10.1111/pcn.12810. Epub 2019 Jan 22.
- Background: PubMed 22070661Hollifield M. Acupuncture for posttraumatic stress disorder: conceptual, clinical, and biological data support further research. CNS Neurosci Ther. 2011 Dec;17(6):769-79. doi: 10.1111/j.1755-5949.2011.00241.x. Epub 2011 Feb 26.
- Background: PubMed 23476697Kim YD, Heo I, Shin BC, Crawford C, Kang HW, Lim JH. Acupuncture for posttraumatic stress disorder: a systematic review of randomized controlled trials and prospective clinical trials. Evid Based Complement Alternat Med. 2013;2013:615857. doi: 10.1155/2013/615857. Epub 2013 Feb 6.
- Background: PubMed 22773206Sniezek DP. Community-Based Wounded Warrior Sustainability Initiative (CBWSI): an integrative medicine strategy for mitigating the effects of PTSD. J Rehabil Res Dev. 2012;49(3):ix-xix. doi: 10.1682/jrrd.2012.02.0025. No abstract available.
- Background: PubMed 30549498Huang W, Johnson TM, Kutner NG, Halpin SN, Weiss P, Griffiths PC, Bliwise DL. Acupuncture for Treatment of Persistent Disturbed Sleep: A Randomized Clinical Trial in Veterans With Mild Traumatic Brain Injury and Posttraumatic Stress Disorder. J Clin Psychiatry. 2018 Dec 11;80(1):18m12235. doi: 10.4088/JCP.18m12235.
- Background: PubMed 25397825Engel CC, Cordova EH, Benedek DM, Liu X, Gore KL, Goertz C, Freed MC, Crawford C, Jonas WB, Ursano RJ. Randomized effectiveness trial of a brief course of acupuncture for posttraumatic stress disorder. Med Care. 2014 Dec;52(12 Suppl 5):S57-64. doi: 10.1097/MLR.0000000000000237.
- Background: PubMed 26530240King CH, Moore LC, Spence CD. Exploring Self-Reported Benefits of Auricular Acupuncture Among Veterans With Posttraumatic Stress Disorder. J Holist Nurs. 2016 Sep;34(3):291-9. doi: 10.1177/0898010115610050. Epub 2015 Nov 3.
- Background: PubMed 29620393Hull A, Brooks Holliday S, Eickhoff C, Sullivan P, Courtney R, Sossin K, Adams A, Reinhard M. Veteran participation in the integrative health and wellness program: Impact on self-reported mental and physical health outcomes. Psychol Serv. 2019 Aug;16(3):475-483. doi: 10.1037/ser0000192. Epub 2018 Apr 5.
- Individual participant dataSharing planned: No. We do not plan on sharing data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dragons acupuncture and Dragons acupressure in people with PTSD and Post Traumatic Stress Disorder, run by Paul Crawford at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PTSD Scale for DSM-5 (CAPS-5) (time frame: visit 1 (week 0)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05516862, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.