Acupuncture for PTSD

Overseen By Amanda Crawford, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Paul Crawford

Disqualifiers: Pregnancy, Recent mental hospitalization, others

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a specific type of acupuncture can reduce symptoms in people with PTSD (Post-Traumatic Stress Disorder). Participants receive either the actual Dragons acupuncture, a sham acupressure that mimics the procedure, or a placebo touch, allowing researchers to assess its effectiveness. This trial is ideal for active duty military members or their families with PTSD symptoms who can access care at Nellis Air Force Base. As an unphased trial, it offers a unique opportunity to contribute to innovative PTSD treatment research.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot be receiving acupuncture or other non-medication treatments specifically for PTSD during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that acupuncture can safely treat PTSD. Previous studies have found that acupuncture treatments successfully reduced PTSD symptoms without major side effects. For example, one study showed that participants experienced fewer PTSD, depression, and pain symptoms after 12 weeks of acupuncture. Another study confirmed that acupuncture was effective and well-tolerated among combat veterans with PTSD.

While these findings are promising, individual experiences can vary. Most studies suggest that acupuncture is generally safe, but discussing any concerns with a healthcare provider before joining a trial is essential. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Dragons acupuncture for PTSD because it offers a unique, non-pharmacological approach that could complement or provide an alternative to traditional treatments like cognitive behavioral therapy and medication. Unlike standard therapies that often focus on altering brain chemistry or behavior, Dragons acupuncture targets specific points on the body to potentially alleviate symptoms through physical means. This method may offer fewer side effects compared to medications and could provide relief for individuals who haven't responded well to other treatments. The two additional methods being studied, Dragons sham acupressure and lightly touching Dragons points, will help determine the specific effectiveness of real acupuncture compared to placebo effects, offering new insights into how acupuncture might benefit PTSD patients.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research has shown that acupuncture can help reduce symptoms of PTSD. Some studies found it to be as effective as cognitive-behavioral therapy (CBT), a common PTSD treatment. Acupuncture may help by affecting certain brain areas and the body's stress-response system. In this trial, participants in Group 1 will receive Dragons Acupuncture, which involves specific acupuncture points. One study found that after 12 weeks, patients who received acupuncture experienced significant reductions in PTSD, depression, and pain symptoms. This suggests that acupuncture could be a promising option for managing PTSD. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for active duty members and DoD beneficiaries aged 18-65 with PTSD, as indicated by a PCL-5 score of 31 or higher. Participants must be able to receive care at Nellis Air Force Base and not be pregnant, hospitalized for mental health recently, have active suicidal thoughts, or currently receiving specific non-medication PTSD treatments.

Inclusion Criteria

At least 1 positive response to at least one item on the LEC-5

My PTSD score is 31 or higher, indicating I have PTSD.

I am between 18-65 years old and connected to the military as an active member, veteran, spouse, or child.

Exclusion Criteria

Active Suicidal thoughts (is currently considering suicide or has a plan) or suicide attempt within the last year

Pregnant, may be pregnant, or attempting to become pregnant

Legally Authorized Representatives will not be utilized in this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive acupuncture or sham treatments targeting Dragons points for PTSD symptom reduction

8 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dragons acupressure
• Dragons acupuncture
• Dragons placebo

Trial Overview The study tests the effectiveness of Dragons acupuncture versus placebo and acupressure in reducing neuropsychiatric trauma symptoms in individuals with PTSD. It aims to determine which method may offer better recovery outcomes.

How Is the Trial Designed?

Group I: Group 1 Experimental Treatment 1 Intervention

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).

Group II: Group 2 Placebo Group 1 Intervention

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).

Group III: Group 3 Placebo Group 1 Intervention

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).

Dragons acupressure is already approved in United States, European Union for the following indications:

Approved in United States as Seven Dragons for:

• Post-Traumatic Stress Disorder (PTSD)

Approved in European Union as Seven Dragons for:

• Neuropsychiatric trauma
• PTSD

Who Is Running the Clinical Trial?

Paul Crawford

Lead Sponsor

Trials

6

Recruited

970+

Published Research Related to This Trial

This study aims to systematically review the clinical evidence regarding the use of acupuncture as a treatment for posttraumatic stress disorder (PTSD) in military veterans, addressing the limitations of conventional treatments.

The findings will help identify effective research designs and outcomes for future studies, potentially establishing acupuncture as a novel first-line treatment for PTSD in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for military veterans with posttraumatic stress disorder and related symptoms after combat exposure: Protocol for a scoping review of clinical studies. Seung, HB., Leem, J., Kwak, HY., et al.[2023]

Traditional Chinese Medicine (TCM) does not recognize posttraumatic stress disorder (PTSD) as a distinct disease, but historical texts like Huangdi's Canon of Medicine describe conditions with similar causes and symptoms.

Recent studies, particularly following the 2008 Sichuan earthquake, have increased interest in TCM approaches to treating PTSD, suggesting a potential for integrating TCM remedies into contemporary PTSD treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment and research for posttraumatic stress disorder with Chinese medicine. Zhang, YH.[2020]

In a 5-week acupuncture intervention for earthquake victims in Amatrice, Italy, 54.05% of patients reported significant improvements in psychological symptoms and 60.6% in pain symptoms after three daily treatments.

The study found no serious adverse events associated with acupuncture, suggesting it is a safe complementary approach for managing earthquake-related psychological and physical distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Observational Study on Acupuncture for Earthquake-Related Post-Traumatic Stress Disorder: The Experience of the Lombard Association of Medical Acupuncturists/Acupuncture in the World, in Amatrice, Central Italy. Moiraghi, C., Poli, P., Piscitelli, A.[2020]

Acupuncture may significantly reduce PTSD symptoms in adults, with a standardized mean difference of -0.80 compared to other treatments, although the quality of evidence is very low.

Safety data from the studies indicate that acupuncture poses little risk of serious adverse events, with only minor issues like pain and superficial bleeding reported at needle sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for the Treatment of Adults with Posttraumatic Stress Disorder: A Systematic Review and Meta-Analysis. Grant, S., Colaiaco, B., Motala, A., et al.[2022]

Acupuncture significantly reduced PTSD symptoms in service members compared to usual PTSD care, with improvements measured by the PTSD Checklist (PCL) and Clinician-administered PTSD Scale (CAPS) over 12 weeks.

In addition to alleviating PTSD symptoms, acupuncture also led to notable improvements in depression, pain severity, and overall mental and physical health functioning, suggesting it could be a valuable treatment option for those with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized effectiveness trial of a brief course of acupuncture for posttraumatic stress disorder. Engel, CC., Cordova, EH., Benedek, DM., et al.[2014]

A systematic review of 6 clinical trials, including 4 randomized controlled trials, suggests that acupuncture may be effective for treating PTSD, showing similar therapeutic effects to cognitive-behavioral therapy (CBT) and some advantages over waitlist controls.

While acupuncture plus moxibustion showed favorable outcomes compared to selective serotonin reuptake inhibitors (SSRIs) in some measures, the overall evidence remains inconclusive, indicating a need for more rigorous trials to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for posttraumatic stress disorder: a systematic review of randomized controlled trials and prospective clinical trials. Kim, YD., Heo, I., Shin, BC., et al.[2022]

Acupuncture may be an effective treatment for posttraumatic stress disorder (PTSD), supported by one published and one unpublished clinical trial, although more research is needed to confirm its efficacy.

Both modern western medicine and Chinese medicine recognize the complex interactions between individual factors and external conditions in the development of PTSD, and acupuncture has biological effects that could align with known PTSD pathology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for posttraumatic stress disorder: conceptual, clinical, and biological data support further research. Hollifield, M.[2021]

A single session of Thought Field Therapy (TFT) significantly reduced PTSD symptoms in 50 orphaned adolescents affected by the Rwandan genocide, with caregiver ratings showing a decrease in PTSD cutoffs from 100% to 6%.

The positive effects of TFT were sustained over a year, as indicated by follow-up checklists, and the therapy became integrated into the orphanage's culture, highlighting its long-term efficacy and acceptance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of PTSD in Rwandan child genocide survivors using thought field therapy. Sakai, CE., Connolly, SM., Oas, P.[2015]

Acupuncture has been found to have a superior effect on treating post-traumatic stress disorder (PTSD), which is characterized by various abnormal mental symptoms related to stress.

The article reviews the neurobiological mechanisms and brain imaging studies that help clarify how acupuncture may work to alleviate PTSD symptoms, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Modern research progress regarding effect mechanism of acupuncture on post-traumatic stress disorder]. Zhao, Z., Zhang, W., Xing, J., et al.[2016]

Acupuncture has been found to be more effective than both pharmacotherapy and psychotherapy in improving PTSD symptoms, based on a comprehensive review that included 56 acupoint analyses, eight meta-analyses, and 33 mechanistic studies.

The most commonly used acupuncture point for PTSD treatment was GV20, and the mechanisms of action may involve regulating brain structures, the neuroendocrine system, and various signaling pathways, highlighting acupuncture's potential as a therapeutic option for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and underlying mechanisms of acupuncture therapy for PTSD: evidence from animal and clinical studies. Tang, X., Lin, S., Fang, D., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05516862?tab=table

Determining the Right Acupuncture for Good Recovery ... This study seeks to verify that a specific acupuncture treatment is effective at reducing symptoms of neuropsychiatric trauma found in those diagnosed with Post ...

2. withpower.com withpower.com/trial/phase-stress-disorders-traumatic-9-2022-0f17e

Acupuncture for PTSD Research suggests that acupuncture may help reduce PTSD symptoms, with some studies showing it can be as effective as cognitive-behavioral therapy (CBT) and ...

3. neupsykey.com neupsykey.com/adding-a-face-and-the-story-to-the-data-acupuncture-for-ptsd-in-the-military/

Adding a Face and the Story to the Data: Acupuncture ... Acupuncture is a holistic approach, which has been used since ancient times to treat physical, emotional, psychological, and spiritual disorders.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10187757/

Efficacy and underlying mechanisms of acupuncture therapy ... Acupuncture may be effective in treating PTSD by regulating the structure and components of several brain areas, regulating the neuroendocrine system, and ...

5. liebertpub.com liebertpub.com/doi/full/10.1089/acu.2016.29016.cpl

How Do You Treat Post-Traumatic Stress Disorder in Your ... At 12 weeks, the acupuncture treatment group showed significantly greater reductions of PTSD, depression, and pain symptoms; and greater ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/46/NCT02869646/Prot_000.pdf

Protocol Rev 3. 4.10.2018 MH Acupuncture for Combat PTSD Acupuncture for posttraumatic stress disorder: Conceptual, clinical, and biological data support further research. CNS Neurosci Ther, 17, 769 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6493831/

Acupuncture for Posttraumatic Stress Disorder - PubMed Central There is preliminary evidence that acupuncture may be an efficacious, safe, and acceptable treatment for PTSD.

8. liebertpub.com liebertpub.com/doi/full/10.1089/acu.2016.29016.cpl?src=recsys

How Do You Treat Post-Traumatic Stress Disorder in Your ... At 12 weeks, the acupuncture treatment group showed significantly greater reductions of PTSD, depression, and pain symptoms; and greater ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38381417/

Acupuncture for Combat-Related Posttraumatic Stress ... The acupuncture intervention used in this study was clinically efficacious and favorably affected the psychobiology of PTSD in combat veterans.