NCT04464954

BFA Treatment of Pain

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Paul Crawford · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Musculoskeletal Pain
• Acute Pain

Interventions

Type	Name	Description
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
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-04-20
• Completion: 2021-04-20
• First posted: 2020-07-09
• Last updated: 2024-04-04
• Results posted: 2024-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study