Effect of needle selection on battlefield acupuncture tolerance and pain reduction: an exploratory randomized controlled trial

Abstract

Introduction:

There has been limited research comparing the different types of needles used for auricular battlefield acupuncture (BFA). The aim of this exploratory study was to determine the feasibility of examining whether there are differences in needle tolerance and/or pain reduction between different needle types.

Methods:

We conducted an unblinded, exploratory, randomized controlled trial in human subjects with complaints of acute or chronic pain. We randomized 30 patients to receive BFA with ASP needles, disposable needles of 15 mm length or Pyonex needles (n = 10 per group). Differences in Defense and Veteran Pain Rating Scale (DVPRS) scores and needle tolerance questionnaire responses by treatment group and follow-up time point (baseline, 10 min, 24 h and 1 week) were assessed using random effects regression and ordinal logistics models.

Results:

A difference in needle tolerance by treatment group was observed for pain at the site(s) of needling (p = 0.002), which was lower for 15-mm needles (odds ratio (OR) = 0.12, p = 0.005) than for ASP needles, but not significantly different for Pyonex versus ASP (OR = 1.45, p = 0.525). There were no difference in overall patient satisfaction, dizziness, bruising, fatigue or headaches between the three BFA needle groups (p = 0.190). No statistically significant associations were observed between treatment group and clinical characteristics (all p > 0.05). DVPRS scores significantly declined after treatment (interaction beta coefficient (β) = −1.40, p < 0.001) across all treatment groups. Declines were also observed post treatment for DVPRS questions 1 (β = −1.23, p = 0.003), 3 (β = −1.23, p < 0.002) and 4 (β = −1.10, p = 0.002). A decline over time after treatment was also observed for DVPRS question 1 (β = −0.15, p = 0.014), 3 (β = −0.12, 0.049) and 4 (β = −0.13, p = 0.016) but was not DVPRS overall score. No significant interactions by treatment group were observed.

Conclusion:

Testing BFA needle types against each other was feasible and the interventions were acceptable to subjects. Through a post hoc power calculation, this study provides a greater understanding of the number of patients that would be needed to more definitively assess for potential differences in effectiveness (pain reduction) between various types of needles in BFA.

Trial registration number:

NCT04464954 (ClinicalTrials.gov)

Keywords

acupuncture battlefield acupuncture exploratory trial needles pain management pilot trial

Introduction

Battlefield acupuncture (BFA), which was developed by Dr Richard Niemtzow,¹ is a simple standardized auricular acupuncture protocol that is ideal for austere environments. Efficient and low-cost, it can be used to treat acute pain while allowing active-duty military members to return to duty. Pilot studies and case studies have supported the implementation of BFA in the acute treatment of musculoskeletal pain and other ailments within the military and Veterans Affairs (VA) health systems.² In a randomized controlled trial (RCT), 56 patients that were treated for acute sore throat pain with BFA compared to usual treatment showed a significant reduction in pain and nearly a 50% reduction in ibuprofen use and missed work hours, compared to those receiving usual treatment.³ While a full medical acupuncture qualification requires hundreds of hours of training, BFA training requires only 4–8 h.⁴

The United States Department of Defense (DoD) has educated and trained military health system and VA providers in BFA—there is now at least one BFA trained provider in all DoD facilities and most VA facilities.⁵ BFA providers are trained to treat a wide array of pain conditions. A survey of 50 graduates of a 300-h medical acupuncture training program revealed that all were still practicing acupuncture and reported increased satisfaction and decreased opioid prescribing.⁶ This program has shown increased patient-centered communication and enhanced patient-physician relationships.^7,8 Furthermore, 172 patients were observed over the course of one year for treatment of chronic pain at this base, and there was a 45% reduction in opioid use with comparable reductions in muscle relaxants and non-steroidal anti-inflammatory drug (NSAID) use.⁹ Providers trained in medical acupuncture show significant decreases in opioid prescribing practices compared to those with no acupuncture training.¹⁰

The protocol for BFA needle placement includes a stepwise progression of needle insertion at five different traditional acupuncture point locations in the ear: Cingulate Gyrus followed sequentially by Thalamus, Omega 2, Point Zero and Shenmen (Figure 1(a)). After each needle the patient’s pain is reassessed. If an analgesic effect is reached, there is no need to continue with the subsequent needle insertion.¹ In the DoD, BFA is taught using only ASP gold-plated (Sedatelec) needles; however, other needles are used commonly in acupuncture practice (Figure 1(b)). These include disposable needles of 15 mm length (Seirin J-type, with guide tube) and 0.2 gauge × 0.9 mm Seirin Pyonex needles (Figure 1(b)).

Figure 1.

(a) Battlefield acupuncture (BFA) needle placement. (b) Pyonex needle (far left), 15 mm Seirin J-type needle, pictured without guide tube (middle left) and ASP needle (middle right) with United States dime (17.9 mm diameter) for scale (far right).

While BFA appears to be effective, to our knowledge, no research has compared the three commonly used needles for this technique against each other, either in terms of patient tolerance or pain. By studying treatment outcomes with each needle type and patient preference regarding the three types of needle, we sought to determine which needles are better tolerated by patients and whether there is similar treatment efficacy across the needle types. Anecdotally, many patients report not liking BFA because of the pain associated with ASP needle insertion or tenderness over subsequent days. Demonstrating improved tolerance with certain needles while maintaining efficacy could potentially lead to more patients being open to BFA and thereby achieve a reduction in opioid use. Accordingly, we conducted an exploratory RCT to determine whether testing needle types against each other is likely to be worthwhile in a future, fully-powered trial.

Methods

Participants

We recruited active-duty and DoD beneficiaries at the Mike O’Callaghan Military Medical Center at Nellis Air Force Base who were ⩾ 18 years old had a scheduled Family Medicine residency clinic visit for pain of any kind. Providers notified research coordinators who then approached potential subjects for consideration of enrollment in this study. Exclusion criteria included: rheumatologic and autoimmune conditions; contraindications to needle use; evidence of or history of clinically significant immune deficiency, hematological, oncological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric or neurologic conditions; severe allergic disease (including allergy to metals and adhesive tapes); progressive radiating pain with motor-sensory changes related to their present pain complaint; and treatment with acupuncture or auricular therapy within the last year. The Institutional Review Board at the Wilford Hall Ambulatory Surgical Center approved this study (FWH20200117 H), which was prospectively registered at ClinicalTrials.gov (NCT04464954) on 29 June 2020. Our first subject was recruited on 19 August 2020 and our last subject was recruited on 31 March 2021.

Outcome measures

Our two pre-specified primary outcome measures for this study were: (1) the Defense and Veterans Pain Rating Scale (DVPRS), as a marker of effectiveness (Figure 2); and (2) a needle tolerance questionnaire (Figure 3). A priori, we aimed to measure DVPRS scores pre-acupuncture and again at 10–15 min, 24 h and 1 week post-acupuncture (four time points) and to administer the needle tolerance questionnaire at 1 week post-acupuncture (single time point), although the latter was ultimately administered multiple times. No secondary outcome measures were pre-specified.

Figure 2.

Defense and Veterans Pain Rating Scale (DVPRS) questionnaire.

Figure 3.

Needle tolerance questionnaire.

The DVPRS is a widely used 11-point linear pain scale and quality of life questionnaire (with 0 indicating no pain and 10 indicating severe pain). The DVPRS been specifically validated in military populations,¹¹ its reliability and validity for the measurement of both acute and chronic pain have been confirmed, and it is currently the standard for pain measurement throughout DoD and VA health systems. The needle tolerance questionnaire (which has not been validated) was developed in house and included a 5-point (1–5) ordinal scale to evaluate pain at the needling sites (with 1 indicating no pain and 5 indicating constant pain).

Experimental groups

Following enrollment, subjects were randomized into three groups in blocks of three using a random number generator. The research coordinator was blinded until informed consent was signed, after which an independent assigned research coordinator provided subject allocation based off a master randomization list. Due to the nature of our study, subject blinding was not feasible. Group 1 was assigned to BFA with ASP gold-plated (Sedatelec) needles, group 2 was assigned to BFA with disposable Seirin needles of 15 mm length (Seirin J-type no. 1 (0.16 mm diameter, Japanese gauge 1, Chinese gauge 40) and group 3 was assigned to BFA using Pyonex needles. A baseline DVPRS score and DVPRS supplemental questionnaire scores were obtained before treatment. The needle tolerance questionnaire was also administered at multiple time points to measure adverse effects, inconvenience and satisfaction. BFA treatment was then completed according to each subjects’ random group allocation. The physicians on the research team who performed the treatment had previously undergone 300-h acupuncture training courses and had practiced acupuncture regularly for many years prior to their participation in this study.

Acupuncture and data collection

For consistency, one of the two following acupuncture procedures was used across the subject population. For the first option, either the left or right ear was chosen for the placement of the needles based on hand dominance or laterality of the subject’s pain. Then, a needle was inserted at Cingulate Gyrus and the patient was ambulated to determine a new pain level. Needles were placed in a similar sequential manner at Thalamus, Omega 2, Point Zero and Shenmen. Pain was evaluated in between each needle placement. After the dominant ear received needles at all the BFA points, the pain level was evaluated. If pain persisted, the contralateral ear was needled in the same fashion. Alternatively, providers had the option to insert needles at all BFA points sequentially in one ear and then to have the patient ambulate. Ambulation time (and distance) was not standardized but did not exceed 1 min. If adequate analgesia was not achieved (pain level of 0–1) then needles were inserted at all BFA points in the opposite ear. Of note, both of these procedures were deviations from the original BFA protocol as taught by Dr Niemtzow,¹ who would determine the side with greater pain relief after placing one needle on each side, then continue to needle the BFA points on the more effective side prior to returning to the opposite ear. Per BFA protocols, needle placement ceases if resolution of pain is achieved (pain level of 0–1) prior to all 10 needles being placed in the ears. After 10 min of BFA, the DVPRS was obtained for post-treatment data and the needle tolerance questionnaire was completed. ASP gold-plated (Sedatelec) needles remained in place for 2–8 days and were allowed to fall out on their own. Serin J-type disposable needles (0.16 mm × 15 mm) remained in place for 15–30 min and were removed by a member of the study staff. Pyonex needles remained in the ears for 2–21 days and were allowed to fall out on their own. Post care instructions for needles left in place (ASP and Pyonex) were given to each subject. Subjects were then offered naproxen 220 mg twice daily as standard of care treatment for pain and discharged from the clinic. Subjects were subsequently contacted in person, over telephone or via SurveyMonkey or GoogleDocs to complete additional DVPRS and DVPRS supplemental questionnaires, as well as the needle tolerance questionnaire, at 24 ± 4 h and 7 ± 2 days post-treatment.

Statistical analysis

As this was an exploratory RCT, an a priori power calculation was not performed; however, assuming a 30% drop-out rate, we initially aimed to recruit a total of 39 patients in order to achieve an arbitrary target of n = 10 patients per group for data analysis (n = 30 in total).

Baseline characteristics—including age, sex, any prescription for pain medication, naproxen prescription, ears treated (left/right/both) and pain (DVPRS scores)—were summarized and compared by treatment group using one-way analysis of variance (ANOVA) for age/DPVRS and Fisher’s exact test for all other (categorical variables).

After assessing skewness (all < 0.39) and kurtosis (all < 2.4), follow-up DVPRS scores were found to be normally distributed and so were summarized as mean ± standard deviation. Needle tolerance questionnaire responses were not normally distributed and so were summarized as median [interquartile range (IQR)]. Changes in DVPRS after treatment were assessed using random effects regression to account for repeated measures, including parameters for post-treatment (dichotomous) and days post-treatment. To assess differential changes by treatment group, another model was constructed, which added parameters for the interaction between treatment group and the dichotomous post-treatment variable. Differences in needle tolerance by group were assessed using random effects ordinal logistic models, adjusted for follow-up time. The treatment group variable was analyzed using a likelihood ratio test. For instances where differences by treatment group were observed, the treatment group comparison statistics are reported.

Results

A total of 31 patients were assessed for enrolment in the study, among which 30 met the inclusion criteria (Figure 4). Ten patients were assigned randomly to each group, which received BFA using ASP needles, disposable needles of 15 mm length and Pyonex needles, respectively. There were no documented harms or unintended effects of BFA in this study.

Figure 4.

Consolidated STandards of Reporting Trials (CONSORT) flow diagram.

Demographic data, including age and sex, were similar between the three groups, with no significant differences at baseline (Table 1). The distribution of males and females between groups was similar; however, there were more women than men overall in the study (24 women vs 6 men). The median age per group was between 43 and 51 years. Pain medication use was similar between the groups, with 12 patients using some form of analgesia (such as ibuprofen, acetaminophen or similar over-the-counter medications). Six subjects accepted the prescribed naproxen 220 mg twice daily, with no between-group differences in uptake. Needle use including number and bilaterality of needle placement was also similar between groups, and 23 out of 30 subjects had 10 needles placed. We did not evaluate how long the semi-permanent needles stayed in the ear.

Table 1.

Baseline characteristics of participants by treatment group.

	ASP group	15 mm group	Pyonex group	p-value
Age (years)	51 ± 11.2	46 ± 13.5	43 ± 15.5	0.381
Sex
Male	3 (30)	0 (0)	3 (30)	0.195
Female	7 (70)	10 (100)	7 (70)
Any pain medication use	4 (40)	7 (70)	5 (50)	0.534
Prescribed naproxen	3 (30)	3 (30)	0 (0)	0.195
Ears treated
Both	5 (50)	9 (90)	8 (80)	0.119
Right only	0 (0)	0 (0)	1 (10)
Left only	5 (50)	1 (10)	1 (10)
DVPRS score	4.2 ± 0.9	5.1 ± 1.6	4.9 ± 2.2	0.460

Data are mean ± standard deviation or n (%). Differences between groups for categorical variables were analyzed using Fishers exact test. Age was compared between groups using one-way analysis of variance. DVPRS: Defense and Veterans Pain Rating Scale.

Pain scores

Although it was not intended that this study be adequately powered to detect differences between the three treatments in terms of the effects of BFA on pain, it was noted that DVPRS scores significantly declined post-treatment across all three treatment groups (p < 0.001; Table 2), as did individual scores for DVPRS questions 1, 3 and 4. A decline over time after treatment was also observed for DVPRS questions 1, 3 and 4 but not for overall DVPRS scores. No significant interactions by treatment group were observed.

Table 2.

Changes in DVPRS scores following treatment and associations between treatment group and follow-up time point.

Outcome measure	Treatment group	Mean ± standard deviation				Beta coefficient (p-value)
Outcome measure	Treatment group	Pre-treatment	10 min	24 h	1 week	Post-treatment	Days post-treatment	Interaction: 15 mm * post-treatment	Interaction: Pyonex * post-treatment
DVPRS	ASP	4.2 ± 0.9	3.2 ± 0.8	3.0 ± 1.6	3.3 ± 1.3	−1.40 (p < 0.001)	−0.02 (p = 0.539)	−0.93 (p = 0.080)	−0.33 (p = 0.528)
	15 mm	5.1 ± 1.6	3.7 ± 2.0	2.8 ± 1.8	2.9 ± 2.5
	Pyonex	4.9 ± 2.2	4.0 ± 2.5	3.1 ± 2.0	3.5 ± 2.9
DVPRS question 1	ASP	4.4 ± 1.9	3.9 ± 2.4	2.9 ± 1.9	2.7 ± 2.7	−1.23 (p = 0.003)	−0.15 (p = 0.014)	−1.13 (p = 0.204)	−0.03 (p = 0.970)
	15 mm	6.1 ± 2.1	5.4 ± 2.2	2.7 ± 2.9	3.1 ± 2.6
	Pyonex	4.9 ± 2.4	4.7 ± 2.5	3.0 ± 2.3	3.2 ± 3.1
DVPRS question 2	ASP	3.7 ± 2.4	3.4 ± 2.2	3.4 ± 2.5	3.8 ± 3.2	−0.76 (p = 0.108)	−0.13 (p = 0.057)	−1.60 (p = 0.132)	−1.27 (p = 0.232)
	15 mm	4.9 ± 3.6	4.3 ± 3.6	2.6 ± 2.5	2.5 ± 2.5
	Pyonex	5.5 ± 2.8	5.4 ± 2.8	3.9 ± 2.9	2.9 ± 3.6
DVPRS question 3	ASP	3.7 ± 2.3	3.3 ± 2.4	2.0 ± 1.4	2.7 ± 2.5	−1.23 (p = 0.002)	−0.12 (p = 0.049)	−0.43 (p = 0.626)	−1.10 (p = 0.218)
	15 mm	3.9 ± 3.0	3.9 ± 3.0	1.3 ± 1.8	2.1 ± 2.4
	Pyonex	5.1 ± 3.2	4.5 ± 3.3	2.2 ± 2.9	2.2 ± 2.4
DVPRS question 4	ASP	3.6 ± 2.4	3.1 ± 2.6	2.3 ± 1.8	2.4 ± 3.1	−1.10 (p = 0.002)	−0.13 (p = 0.016)	−0.37 (p = 0.641)	−0.93 (p = 0.236)
	15 mm	3.6 ± 2.7	3.6 ± 2.7	1.2 ± 1.8	1.9 ± 2.8
	Pyonex	5.1 ± 2.5	4.4 ± 2.9	2.7 ± 2.7	2.4 ± 2.7

Outcomes were analyzed using random effects regression models including parameters for post-treatment follow-up (dichotomous) and days post-follow-up. Separate models were also conducted to assess the interaction between treatment group (referent = ASP) and post-treatment follow-up changes (interaction beta coefficients and p-values are reported in the two right-most columns). DVPRS: Defense and Veterans Pain Rating Scale.

Needle tolerance

As shown in Table 3, a significant difference in needle tolerance by treatment group was observed with respect to pain at the site(s) of needling (needle tolerance question 2). Pairwise comparisons between groups showed that pain was lower in the 15 mm needle group compared to the ASP group (OR = 0.12, p = 0.005) but not significantly different in Pyonex versus ASP groups (OR = 1.45, p = 0.525). No other significant differences were seen in the responses to any other needle tolerance questions (p > 0.05). The proportion of patients reporting “other” adverse effects (needle tolerance question 7) at 10 min, 24 h and 1 week, respectively, was: 0%, 20% and 0% in the ASP group; 0%, 0% and 10% in the 15 mm needle group; and 10%, 20% and 10% in the Pyonex group. There were no significant differences between groups in these responses (p = 0.437).

Table 3.

Description of needle tolerance by treatment group and follow-up time point.

Outcome measure	Treatment group	Median [interquartile range]			Overall p-value for treatment group
Outcome measure	Treatment group	10 min	24 h	1 week	Overall p-value for treatment group
Needle tolerance question 1	ASP	1.0 [1.0–1.0]	1.0 [1.0–1.0]	1.0 [1.0–1.0]	p = 0.760
	15 mm	1.0 [1.0–1.0]	1.0 [1.0–1.0]	1.0 [1.0–1.0]
	Pyonex	1.0 [1.0–1.0]	1.0 [1.0–1.0]	1.0 [1.0–1.0]
Needle tolerance question 2	ASP	1.5 [1.0–2.8]	2.5 [1.0–3.0]	1.0 [1.0–2.0]	p = 0.002
	15 mm	1.0 [1.0–2.5]	1.0 [1.0–1.0]	1.0 [1.0–1.0]
	Pyonex	1.0 [1.0–2.8]	3.0 [2.2–3.0]	1.5 [1.0–2.0]
Needle tolerance question 3	ASP	1.0 [1.0–1.0]	1.0 [1.0–1.0]	1.0 [1.0–1.0]	*
	15 mm	1.0 [1.0–1.0]	1.0 [1.0–1.0]	1.0 [1.0–1.0]
	Pyonex	1.0 [1.0–1.0]	1.0 [1.0–1.0]	1.0 [1.0–1.0]
Needle tolerance question 4	ASP	1.0 [1.0–1.0]	1.0 [1.0–1.0]	1.0 [1.0–1.0]	p = 0.314
	15 mm	1.0 [1.0–1.0]	1.0 [1.0–1.0]	1.0 [1.0–1.0]
	Pyonex	1.0 [1.0–1.0]	1.0 [1.0–1.0]	1.0 [1.0–1.0]
Needle tolerance question 5	ASP	1.0 [1.0–1.0]	1.0 [1.0–1.0]	1.0 [1.0–1.8]	p = 0.207
	15 mm	1.0 [1.0–1.0]	1.0 [1.0–1.0]	1.0 [1.0–1.0]
	Pyonex	1.0 [1.0–1.0]	1.0 [1.0–1.0]	1.0 [1.0–1.0]
Needle tolerance question 6	ASP	1.0 [1.0–1.0]	1.0 [1.0–1.0]	1.0 [1.0–2.8]	p = 0.358
	15 mm	1.0 [1.0–1.0]	1.0 [1.0–1.0]	1.0 [1.0–1.0]
	Pyonex	1.0 [1.0–1.8]	1.0 [1.0–2.0]	1.0 [1.0–1.8]
Needle tolerance question 8	ASP	2.0 [2.0–2.0]	1.0 [1.0–2.8]	1.0 [1.0–2.5]	p = 0.716
	Pyonex	1.0 [1.0–1.0]	2.0 [1.0–3.0]	1.0 [1.0–2.0]
Needle tolerance question 9	ASP	1.0 [1.0–1.0]	1.0 [1.0–1.0]	1.0 [1.0–1.0]	p = 0.128
	Pyonex	1.0 [1.0–1.0]	1.5 [1.0–2.0]	1.0 [1.0–2.0]
Needle tolerance question 10	ASP	1.0 [1.0–1.0]	1.0 [1.0–2.0]	2.5 [2.0–5.0]	p = 0.782
	Pyonex	1.0 [1.0–1.0]	2.0 [1.0–2.0]	2.0 [1.2–4.8]
Needle tolerance question 11	ASP	1.0 [1.0–1.0]	1.0 [1.0–1.0]	1.0 [1.0–1.0]	p = 0.590
	Pyonex	N/A	1.0 [1.0–1.0]	1.0 [1.0–1.0]
Needle tolerance question 12	ASP	1.5 [1.0–2.8]	1.5 [1.0–3.0]	1.0 [1.0–3.8]	p = 0.527
	Pyonex	2.0 [1.2–2.8]	2.0 [1.0–3.0]	3.0 [1.2–4.0]

N/A = no responses. Needle tolerance question 7 is reported as percentages per group (see main text). Needle tolerance questions 8 to 12 pertain only to auricular and semi-permanent needles, therefore no data is presented for the 15 mm group. Outcomes were analyzed using random effects ordinal logistic regression models. The p-values are derived from the likelihood ratio test for including the treatment group variable in the model, which was adjusted for follow-up time period. * indicates insufficient variation between groups for statistical analysis.

Post hoc power and sample size calculations

A post hoc power calculation was performed, which demonstrated that we had only 8% power to detect a 0.1 difference in DVPRS scores between groups (10% difference) at an α level of 0.05. We then estimated the sample size that would be needed for a more definitive trial with two study groups (one treatment group compared to a reference group) and four time points (one baseline assessment and three equally-spaced follow-ups). Assuming a linear trend in DVPRS reduction over time, we determined that 50 participants per group would be needed to detect a 25% reduction in DVPRS scores from baseline by the last follow-up with ⩾ 80% power.

Discussion

In the present study, we found that testing needle types against each other was feasible and that the intervention was acceptable to subjects. We also developed a better understanding of the number of patients needed to more robustly assess the impact of BFA pain. In our small sample of patients, disposable needles of 15 mm length appeared to be better tolerated than ASP or Pyonex needles, although this finding must be interpreted with caution given that our small sample size and the fact we did not correct for multiple testing together confer a high risk of type 1 error (i.e. a false positive result). We also noted that DVPRS pain scores improved over time in all three groups. While this finding is consistent with our suspicion that BFA using any of the three needle types is efficacious, we cannot draw such a conclusion based on our data, given we used a superiority (not equivalence) trial design and did not control for other factors that may explain decreased pain scores over time, such as the Hawthorne effect or regression to the mean.

Nevertheless, our findings are somewhat encouraging and suggest that use of different needle types in BFA treatment should be studied more definitively. If confirmed in a definitive trial, the potential superiority of BFA using needles of 15 mm length (with respect to needling site pain) could have implications both for the economic burden related to pain treatments and for the incidence of opioid addiction in the population. If more patients are willing to try BFA because they do not have to deal with ASP needles, a greater number may choose acupuncture as a pain treatment.

Making medical treatments a more comfortable experience increases adherence and the number of patients who seek out those treatments; for example, colonoscopies under sedation minimize patient discomfort and increase satisfaction and willingness to undergo future colonoscopies.¹² Anxiety and pain during dental and orthodontic procedures makes anesthesia key in convincing patients to undergo treatment and makes analgesic prescription especially important for post-procedural pain control.¹³

Medication adherence is also an issue due to potential adverse effects. For example, tolerability is an issue in atomoxetine treatment for attention-deficit/hyperactivity disorder and has been cited as a reason for many patients’ decisions to discontinue the medication,¹⁴ and the compliance of patients who require insulin therapy may be negatively impacted by injection-related discomfort.¹⁵ The latter observation has led to the development of thinner gauge needles and insulin pen needles, as well as advancements in alternative insulin delivery routes such as oral or transdermal (needle-free injection technology) to reduce patients’ pain perception and potentially increase medication compliance.^16–18

Discomfort with BFA using ASP needles can reduce patient adherence to repeated treatments. Acute pain during needle insertion, as well as tenderness and soreness at the needling site afterwards, affects both patients who have tried ASP BFA and are unwilling to continue treatment, as well as patients who have heard through word of mouth that ASP needles are painful and irritating. Post-needling soreness in myofascial trigger point dry needling has also been shown to reduce patient satisfaction and treatment adherence.¹⁹

Limitations

As an exploratory study, this investigation is greatly limited by the small sample size of n = 30; therefore, we are unable to make definitive clinical statements or recommendations from this data. In addition, the distribution of patients with acute and chronic pain across the study groups was not tracked and may have led to bias in tolerability results. It is also possible that the different needle types do actually have differential effects on pain reduction, which could not be detected due to the high risk of type 2 error (i.e. a false negative result). In addition, 24 out of the 30 patients were female (80%) and thus the findings may not be generalizable to the overall population with a greater proportion of males. This is particularly relevant when considering the United States Air Force, in which approximately 80% of personnel are male.²⁰ Thus, a higher powered, multi-site study conducted over a longer period is needed to assess differences in pain reduction and tolerance between different types of acupuncture needle.

Conclusion

In the present study, we found that testing needle types against each other was feasible and that the interventions were acceptable to subjects. Moreover, we have developed a better understanding of the number of patients that would be needed to more definitively assess for potential differences in effectiveness (pain reduction) between various types of needles in BFA.

Footnotes

Acknowledgements

We would like to thank Jill M. Clark and Jonica Estrada for their help with this research, Amanda Crawford at Eagle Global Scientific for her assistance with preparing this manuscript, and Weston Williams, PhD (Public Health Analytic Consulting Services, Inc., Hillsborough, NC, USA) for help with the statistical analysis. Please note that the views expressed in this article are those of the authors and do not reﬂect the ofﬁcial policy or position of the United States Air Force, the Department of Defense or the United States Government.

Declaration of conflicting interests

The authors declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article.

Funding

The authors received no financial support for the research, authorship and/or publication of this article.

ORCID iD

Paul F Crawford

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