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The aim of this pilot study is to conduct an unblinded pilot randomized clinical study on the effectiveness and tolerability of auricular semi-permanent (ASP) vs intradermal (long), and pyonex needles in Battlefield Acupuncture (BFA) for the treatment of pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auricular semi-permanent (ASP gold) needles | Experimental |
| |
| Intradermal (long) needles using J-type No. 2 (.18)x 15mm | Experimental |
| |
| Pyonex needles (Seirin Yellow 0.2 x 0.6mm) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auricular semi-permanent (ASP gold) needles | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness: Scale | Defense and Veterans Pain Rating Scale (DVPRS).DVPRS is an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS demonstrates linear scale qualities allowing parametric methods to be used. | repeated measurements of change in the DVRPS. (Pre-acupuncture, 10-15 minutes post-acupuncture, 24 hours post-acupuncture, and 1 week post-acupuncture) |
| Needle Tolerance: Questionnaire | Measured using an in-house developed questionnaire. It employed a 5-point (1-5) ordinal scale to evaluate pain at needle site. Lower score (1) is no pain. Higher score (5) is constant pain. | average pain at needle site 1-week post insertion |
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**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study**
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mike O'Callaghan Military Medical Center | Nellis Air Force Base | Nevada | 89191 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| Background | Melzack, Ronald. Pain Forum. Volume 5 (2). Summer 1996. Pages 128-138. | ||
| 19174438 | Background | 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. | |
| 29198932 |
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We do not plan on sharing data.
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1 subject screen failed, leaving 30 subjects in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effectiveness: Scale | Defense and Veterans Pain Rating Scale (DVPRS).DVPRS is an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS demonstrates linear scale qualities allowing parametric methods to be used. | Posted | Mean | Full Range | score on a scale | repeated measurements of change in the DVRPS. (Pre-acupuncture, 10-15 minutes post-acupuncture, 24 hours post-acupuncture, and 1 week post-acupuncture) |
|
through study completion, 1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse Event | Ear and labyrinth disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Crawford | Mike O'Callaghan Military Medical Center | 7026532067 | amanda.j.crawford.ctr@health.mil |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 16, 2021 | Aug 11, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 13, 2020 | Jan 13, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D009339 | Needles |
| D007271 | Injections, Intradermal |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D007279 | Injections, Subcutaneous |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
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| Intradermal (long) needles using J-type No. 2 (.18)x 15mm | Device | 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) | Device | Pyonex needles will remain in subject ears for 2-21 days and allowed to fall out on their own. |
|
| Background |
| 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. |
| 27471137 | Background | 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. |
| Background | 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 |
| Background | 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 |
| Background | 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. |
| 27601311 | Background | 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. |
| Background | Defense and Veterans Center for Integrative Pain Management.(2016). Retrieved from http://www. dvcipm.org/. |
| Background | 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/. |
| Background | Koffman, R., & Helms, M. (2013). Acupuncture and PTSD: 'come for the needles, stay for the therapy'. Psychiatric Annals, 43(5),236e239. |
| 28874924 | Background | 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. |
| 29937955 | Background | Niemtzow RC. Battlefield Acupuncture: My Story. Med Acupunct. 2018 Apr 1;30(2):57-58. doi: 10.1089/acu.2018.29077.rcn. No abstract available. |
| Background | DHA-PI 6025.33, Acupuncture Practice in Military Medical Treatment Facilities February 20, 2020. Retrieved from pdf. |
| Background | 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. |
| 41317090 | Derived | Burton SJ, Moss DA, Crawford PF 3rd. Effect of needle selection on battlefield acupuncture tolerance and pain reduction: an exploratory randomized controlled trial. Acupunct Med. 2026 Feb;44(1):25-35. doi: 10.1177/09645284251400386. Epub 2025 Nov 29. |
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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
| OG002 | 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. |
|
|
| Primary | Needle Tolerance: Questionnaire | Measured using an in-house developed questionnaire. It employed a 5-point (1-5) ordinal scale to evaluate pain at needle site. Lower score (1) is no pain. Higher score (5) is constant pain. | Posted | Mean | Full Range | score on a scale | average pain at needle site 1-week post insertion |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | 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. | 0 | 10 | 0 | 10 | 1 | 10 |
| EG002 | 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. | 0 | 10 | 0 | 10 | 1 | 10 |
| Adverse Event | Ear and labyrinth disorders | Systematic Assessment | headache |
|
| Adverse Event | Skin and subcutaneous tissue disorders | Non-systematic Assessment | numbness/tingles |
|
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004358 |
| Drug Therapy |
| D013812 | Therapeutics |