Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
30 participants
INTERVENTIONAL
2020-11-01
2021-04-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Rapid Extremity Pain Relief by Battlefield Acupuncture After Orthopedic Surgery
NCT02093637
Battlefield Acupuncture for Low Back Pain
NCT03491124
Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled Study
NCT05969353
PEACE: Comparing Chronic Pain Treatment Options
NCT02979574
Veteran Ear Acupuncture Pilot Project
NCT04208659
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
2. Identify patient experiences and tolerance of three commonly used acupuncture needles at Mike O'Callaghan Military Medical Center at Nellis Air Force Base. This study will compare 30 patients (10 per needling group) and will serve as a pilot study for a potential larger randomized control trial (RCT) across multiple MTFs in the Defense Health Agency (DHA) to establish better BFA care practices. We will be recruiting a total of 39 subjects, which is inclusive of a 30% drop out rate to accommodate those that may be lost to the study or have missing data to achieve a final total of 30 subjects.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Auricular semi-permanent (ASP gold) needles
Auricular semi-permanent (ASP gold) needles
ASP semi-permanent Battlefield Acupuncture needles are semi-permanent needles that will remain in subject ears for 2-8 days and will be allowed to fall out on their own
Intradermal (long) needles using J-type No. 2 (.18)x 15mm
Intradermal (long) needles using J-type No. 2 (.18)x 15mm
Intradermal (long) needles will remain in subject ears for 15-30 minutes and will be removed by a member of the study staff.
Pyonex needles (Seirin Yellow 0.2 x 0.6mm)
Pyonex needles (Seirin Yellow 0.2 x 0.6mm)
Pyonex needles will remain in subject ears for 2-21 days and allowed to fall out on their own.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Auricular semi-permanent (ASP gold) needles
ASP semi-permanent Battlefield Acupuncture needles are semi-permanent needles that will remain in subject ears for 2-8 days and will be allowed to fall out on their own
Intradermal (long) needles using J-type No. 2 (.18)x 15mm
Intradermal (long) needles will remain in subject ears for 15-30 minutes and will be removed by a member of the study staff.
Pyonex needles (Seirin Yellow 0.2 x 0.6mm)
Pyonex needles will remain in subject ears for 2-21 days and allowed to fall out on their own.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Acute (0-4 days) musculoskeletal injury
* Injuries eligible for inclusion include all acute non-fracture related musculoskeletal injuries of the axial or peripheral skeleton.
Exclusion Criteria
* Rheumatologic and autoimmune conditions which may be creating pain, such as rheumatoid arthritis, advanced osteoarthritis, or spinal stenosis
* Contra-indication to needle use including known bleeding disorder and psychogenic issues related to needle use (e.g., needle-phobia)
* Evidence or history of clinically significant immune deficiency, hematological, oncological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or severe allergic disease (including to metals and adhesive tapes) which could interfere with this study
* Individuals with progressive radiating pain with motor-sensory changes (including weakness or numbness) related to their presenting pain complaint
* Women who are pregnant, may be pregnant, or attempting to become pregnant
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Paul Crawford
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Paul Crawford
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mike O'Callaghan Military Medical Center
Nellis Air Force Base, Nevada, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Chen YM. Clinical application of lower He-Sea points for abdominal pain [presentation] 28th Annual International Symposium on Acupuncture, Electro-Therapeutics Researches, Columbia University Faculty House, New York, NY, October 27, 2012.
Melzack, Ronald. Pain Forum. Volume 5 (2). Summer 1996. Pages 128-138.
Madsen MV, Gotzsche PC, Hrobjartsson A. Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups. BMJ. 2009 Jan 27;338:a3115. doi: 10.1136/bmj.a3115.
Vickers AJ, Vertosick EA, Lewith G, MacPherson H, Foster NE, Sherman KJ, Irnich D, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis. J Pain. 2018 May;19(5):455-474. doi: 10.1016/j.jpain.2017.11.005. Epub 2017 Dec 2.
Yuan QL, Wang P, Liu L, Sun F, Cai YS, Wu WT, Ye ML, Ma JT, Xu BB, Zhang YG. Acupuncture for musculoskeletal pain: A meta-analysis and meta-regression of sham-controlled randomized clinical trials. Sci Rep. 2016 Jul 29;6:30675. doi: 10.1038/srep30675.
Devitt M. Research Finds Acupuncture Effective for Chronic Pain [Internet]. AAFP Home | American Academy of Family Physicians. 2018 [cited 2020Apr1]. Available from: https://www.aafp.org/home. html
Center for Medicare and Medicaid Services. Decision Summary: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N). Center for Medicare and Medicaid Services. July 15, 2019. https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decisionmemo. aspx?NCAId=295
Pain management task force final report77. (2010). Office of the Army Surgeon General. Retrieved from http://www.armymedicine.army.mil/reports/Pain_Management_Task_Force.pdf.
Walker PH, Pock A, Ling CG, Kwon KN, Vaughan M. Battlefield acupuncture: Opening the door for acupuncture in Department of Defense/Veteran's Administration health care. Nurs Outlook. 2016 Sep-Oct;64(5):491-8. doi: 10.1016/j.outlook.2016.07.008. Epub 2016 Jul 20.
Defense and Veterans Center for Integrative Pain Management.(2016). Retrieved from http://www. dvcipm.org/.
Spotswood, S. (2014). Auricular acupuncture: Convenient technique for battlefield pain. U.S. Medicine, Retrieved from http://www.usmedicine.com/agencies/department-ofdefense-dod/auricular-acupunctureconvenient- techniquefor-battlefield-pain/.
Koffman, R., & Helms, M. (2013). Acupuncture and PTSD: 'come for the needles, stay for the therapy'. Psychiatric Annals, 43(5),236e239.
Crawford P, Penzien DB, Coeytaux R. Reduction in Pain Medication Prescriptions and Self-Reported Outcomes Associated with Acupuncture in a Military Patient Population. Med Acupunct. 2017 Aug 1;29(4):229-231. doi: 10.1089/acu.2017.1234.
Niemtzow, R. (2007). Battlefield acupuncture. Medical Acupuncture,19, 225e228.
DHA-PI 6025.33, Acupuncture Practice in Military Medical Treatment Facilities February 20, 2020. Retrieved from pdf.
Bonakdar RA, Mills PJ. Auricular Acupuncture Therapy for Treatment of Musculoskeletal Pain in the Setting of Military Personnel: A Randomized Trial. United States Naval Medical Center San Diego in collaboration with Scripps Integrative Medical Center at La Jolla, CA. NIH Clinical Trail NCT02263001. Last Updated May 4, 2017.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FWH20200117H
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.