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BFA Treatment of Pain

Primary Purpose

Musculoskeletal Pain, Acute Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Auricular semi-permanent (ASP gold) needles

Intradermal (long) needles using J-type No. 2 (.18)x 15mm

Pyonex needles (Seirin Yellow 0.2 x 0.6mm)

About this trial

This is an interventional treatment trial for Musculoskeletal Pain focused on measuring acupuncture, battlefield acupuncture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

**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

Sites / Locations

Mike O'Callaghan Military Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Auricular semi-permanent (ASP gold) needles

Intradermal (long) needles using J-type No. 2 (.18)x 15mm

Pyonex needles (Seirin Yellow 0.2 x 0.6mm)

Arm Description

Outcomes

Primary Outcome Measures

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.

Needle Tolerance: questionnaire

Will be measured using an in-house developed questionnaire. It employs 5-point ordinal scales to evaluate 12 post-therapy experiences or perception encompassing adverse outcomes, inconveniences, and satisfaction

Secondary Outcome Measures

Full Information

NCT ID

NCT04464954

First Posted

June 29, 2020

Last Updated

January 13, 2022

Sponsor

Paul Crawford

1. Study Identification

Unique Protocol Identification Number

NCT04464954

Brief Title

BFA Treatment of Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

November 1, 2020 (Actual)

Primary Completion Date

April 20, 2021 (Actual)

Study Completion Date

April 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Paul Crawford

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Musculoskeletal Pain, Acute Pain

Keywords

acupuncture, battlefield acupuncture

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Auricular semi-permanent (ASP gold) needles

Arm Type

Experimental

Arm Title

Intradermal (long) needles using J-type No. 2 (.18)x 15mm

Arm Type

Experimental

Arm Title

Pyonex needles (Seirin Yellow 0.2 x 0.6mm)

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Auricular semi-permanent (ASP gold) needles

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Intradermal (long) needles using J-type No. 2 (.18)x 15mm

Intervention Description

Intradermal (long) needles will remain in subject ears for 15-30 minutes and will be removed by a member of the study staff.

Intervention Type

Device

Intervention Name(s)

Pyonex needles (Seirin Yellow 0.2 x 0.6mm)

Intervention Description

Pyonex needles will remain in subject ears for 2-21 days and allowed to fall out on their own.

Primary Outcome Measure Information:

Title

Effectiveness: scale

Description

Time Frame

Four repeated measurements of change in the DVRPS: preacupuncture (Day 0), post-acupuncture (10-15 minutes post needle insertion), 24 hours and one week post-therapy.

Title

Needle Tolerance: questionnaire

Description

Time Frame

Three repeated measurements of change in needle tolerance: post-acupuncture (10-15 minutes post needle insertion), 24 hours and 1 week posttherapy.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

**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

Facility Information:

Facility Name

Mike O'Callaghan Military Medical Center

City

Nellis Air Force Base

State/Province

Nevada

ZIP/Postal Code

89191

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We do not plan on sharing data.

Citations:

Citation

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.

Results Reference

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Citation

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

Results Reference

background

PubMed Identifier

19174438

Citation

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.

Results Reference

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PubMed Identifier

29198932

Citation

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.

Results Reference

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PubMed Identifier

27471137

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.

Results Reference

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Citation

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

Results Reference

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Citation

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

Results Reference

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Citation

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.

Results Reference

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PubMed Identifier

27601311

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.

Results Reference

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Citation

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

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Citation

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/.

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Citation

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

Results Reference

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PubMed Identifier

28874924

Citation

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.

Results Reference

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Citation

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

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Citation

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

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Citation

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.

Results Reference

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BFA Treatment of Pain

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