BFA Treatment of Pain

Acute Pain Clinical Trial

Official title:

Pilot Study: Effect of Battlefield Acupuncture Needle Selection on Symptom Relief and Patient Tolerance in the Treatment of Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04464954
• Other study ID #: FWH20200117H
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: April 20, 2021

Study information

• Verified date: April 2024
• Source: Mike O'Callaghan Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

1. Begin to identify which of 3 needles is most efficacious for BFA treatment of pain; 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 20, 2021
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study**

Inclusion Criteria:

• Active duty and DoD Beneficiaries aged 18 years or older
• 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:

• Taking any opioid medications daily
• 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

Related Conditions & MeSH terms

• Acute Pain
• Musculoskeletal Pain

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Mike O'Callaghan Military Medical Center	Nellis Air Force Base	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Paul Crawford

Country where clinical trial is conducted

United States, 

References & Publications (16)

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.

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

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.

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. — View Citation

Defense and Veterans Center for Integrative Pain Management.(2016). Retrieved from http://www. dvcipm.org/.

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

DHA-PI 6025.33, Acupuncture Practice in Military Medical Treatment Facilities February 20, 2020. Retrieved from pdf.

Koffman, R., & Helms, M. (2013). Acupuncture and PTSD: 'come for the needles, stay for the therapy'. Psychiatric Annals, 43(5),236e239.

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. — View Citation

Melzack, Ronald. Pain Forum. Volume 5 (2). Summer 1996. Pages 128-138.

Niemtzow, R. (2007). Battlefield acupuncture. Medical Acupuncture,19, 225e228.

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.

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/.

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	repeated measurements of change in the DVRPS. (Pre-acupuncture, 10-15 minutes post-acupuncture, 24 hours post-acupuncture, and 1 week post-acupuncture)
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.	average pain at needle site 1-week post insertion