Musculoskeletal PainNCT04464954

BFA Treatment of Pain

A study testing Auricular semi-permanent (ASP gold) needles, Intradermal (long) needles using J-type No. 2 (.18)x 15mm and Pyonex needles (Seirin Yellow 0.2 x 0.6mm) in people with Musculoskeletal Pain and Acute Pain, run by Paul Crawford at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Musculoskeletal Pain, Acute Pain
What is being tested?: Auricular semi-permanent (ASP gold) needles, Intradermal (long) needles using J-type No. 2 (.18)x 15mm and Pyonex needles (Seirin Yellow 0.2 x 0.6mm)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2020to 20 Apr 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Mike O'Callaghan Military Medical Center
Nellis Air Force Base, Nevada, 89191

Other trials in United States

About this study

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

Read the 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.

Conditions: Musculoskeletal Pain, Acute Pain
Being tested: 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)
Keywords: acupuncture, battlefield acupuncture
Medical subject headings: Musculoskeletal Pain, Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Auricular semi-permanent (ASP gold) needlesDevice
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 15mmDevice
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.

Study groups in NCT04464954
Study group	Role	What they receive
Auricular semi-permanent (ASP gold) needles	Experimental	Not described Receives: Device: Auricular semi-permanent (ASP gold) needles
Intradermal (long) needles using J-type No. 2 (.18)x 15mm	Experimental	Not described Receives: Device: Intradermal (long) needles using J-type No. 2 (.18)x 15mm
Pyonex needles (Seirin Yellow 0.2 x 0.6mm)	Experimental	Not described Receives: Device: Pyonex needles (Seirin Yellow 0.2 x 0.6mm)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: average pain at needle site 1-week post insertion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202020 Apr 2021

First posted9 Jul 2020
Study start1 Nov 2020
Primary completion20 Apr 2021
Study completion20 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04464954
Sponsor's protocol ID: FWH20200117H
Status last verified: Apr 2024
First submitted: 29 Jun 2020
Last updated: 4 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: We do not plan on sharing data.

Publications

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.
PubMed 19174438
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.
PubMed 29198932
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.
PubMed 27471137
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.
PubMed 27601311
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.
PubMed 28874924
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.
PubMed 29937955
DHA-PI 6025.33, Acupuncture Practice in Military Medical Treatment Facilities February 20, 2020. Retrieved from pdf.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Musculoskeletal Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study: Effect of Battlefield Acupuncture Needle Selection on Symptom Relief and Patient Tolerance in the Treatment of Pain
ClinicalTrials.gov ID: NCT04464954
Acronym / sponsor ID: FWH20200117H
Conditions: Musculoskeletal Pain, Acute Pain
Keywords: acupuncture, battlefield acupuncture
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Paul CrawfordUS federal agency
Study start: 1 Nov 2020 (actual)
Primary completion: 20 Apr 2021 (actual)
Study completion: 20 Apr 2021 (actual)
First posted: 9 Jul 2020 (actual)
Results: Posted 4 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Auricular semi-permanent (ASP gold) needles	Experimental	Device: Auricular semi-permanent (ASP gold) needles
Intradermal (long) needles using J-type No. 2 (.18)x 15mm	Experimental	Device: Intradermal (long) needles using J-type No. 2 (.18)x 15mm
Pyonex needles (Seirin Yellow 0.2 x 0.6mm)	Experimental	Device: Pyonex needles (Seirin Yellow 0.2 x 0.6mm)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Auricular semi-permanent (ASP gold) needlesASP 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	Device	Auricular semi-permanent (ASP gold) needles
Intradermal (long) needles using J-type No. 2 (.18)x 15mmIntradermal (long) needles will remain in subject ears for 15-30 minutes and will be removed by a member of the study staff.	Device	Intradermal (long) needles using J-type No. 2 (.18)x 15mm
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.	Device	Pyonex needles (Seirin Yellow 0.2 x 0.6mm)

Primary outcome

Effectiveness: Scale
Time frame: repeated measurements of change in the DVRPS. (Pre-acupuncture, 10-15 minutes post-acupuncture, 24 hours post-acupuncture, and 1 week post-acupuncture)
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
Time frame: average pain at needle site 1-week post insertion
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.

Results and safety

Results posted to the registry on 4 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Auricular Semi-permanent (ASP Gold) Needles	10	10
Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm	10	10
Pyonex Needles (Seirin Yellow 0.2 x 0.6mm)	10	10

Primary outcome: Effectiveness: Scale

Time frame: repeated measurements of change in the DVRPS. (Pre-acupuncture, 10-15 minutes post-acupuncture, 24 hours post-acupuncture, and 1 week post-acupuncture). Mean (Full Range). Unit: score on a scale

Measure	Auricular Semi-permanent (ASP Gold) Needles n = 10	Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm n = 10	Pyonex Needles (Seirin Yellow 0.2 x 0.6mm) n = 10
DVPRS preacupuncture	4.2 (3 to 6)	5.1 (2 to 6)	4.9 (2 to 7)
DVPRS postacupuncture (10-15 minutes post)	3.2 (2 to 4)	3.7 (1 to 7)	4.0 (0 to 7)
DVPRS postacupuncture 24 hours	3.0 (1 to 6)	2.8 (0 to 6)	3.1 (0 to 7)
DVPRS postacupuncture 1 week	3.3 (1 to 5)	2.9 (0 to 8)	3.5 (0 to 8)

Primary outcome: Needle Tolerance: Questionnaire

Time frame: average pain at needle site 1-week post insertion. Mean (Full Range). Unit: score on a scale

Measure	Auricular Semi-permanent (ASP Gold) Needles n = 10	Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm n = 10	Pyonex Needles (Seirin Yellow 0.2 x 0.6mm) n = 10
Value	2.0 (1 to 5)	1.0 (1 to 5)	1.8 (1 to 5)

Adverse events

Time frame: through study completion, 1 week. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Auricular Semi-permanent (ASP Gold) Needles	0 of 10 (0%)	1 of 10 (10%)	0 of 10
Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm	0 of 10 (0%)	1 of 10 (10%)	0 of 10
Pyonex Needles (Seirin Yellow 0.2 x 0.6mm)	0 of 10 (0%)	1 of 10 (10%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundChen 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.
BackgroundMelzack, Ronald. Pain Forum. Volume 5 (2). Summer 1996. Pages 128-138.
Background: PubMed 19174438Madsen 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.
Background: PubMed 29198932Vickers 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.
Background: PubMed 27471137Yuan 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.
BackgroundDevitt 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
BackgroundCenter 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
BackgroundPain 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.
Background: PubMed 27601311Walker 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.
BackgroundDefense and Veterans Center for Integrative Pain Management.(2016). Retrieved from http://www. dvcipm.org/.
BackgroundSpotswood, 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/.
BackgroundKoffman, R., & Helms, M. (2013). Acupuncture and PTSD: 'come for the needles, stay for the therapy'. Psychiatric Annals, 43(5),236e239.
Individual participant dataSharing planned: No. We do not plan on sharing data.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness: Scale (time frame: repeated measurements of change in the DVRPS. (Pre-acupuncture, 10-15 minutes post-acupuncture, 24 hours post-acupuncture, and 1 week post-acupuncture)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04464954, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.