Battlefield Acupuncture for Chronic Lower Back Pain
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stephanie K. Bunt
Disqualifiers: Prior BFA treatment, Dementia
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?Lower back pain (LBP) is one of the most common causes of disability, with 68% of adults over 60 years of age suffering from chronic Lower Back Pain (cLBP). In addition to the exacerbation of physical, social and emotional health issues, LBP has a staggeringly high US economic burden. Community-dwelling older adults experience a significant amount of chronic pain and treatments that are effective in their younger adult counterparts (e.g., pain medications, exercise) are often not safe or feasible. Our long-term goal is to decrease cLBP and improve function in older adults residing in continuing care retirement communities (CCRC). Battlefield Acupuncture (BFA), a promising treatment for cLBP, is an auricular (ear-based) treatment intended to compliment traditional allopathic medical treatments for acute and chronic pain. Auricular acupuncture has been implemented and used widely in the US military. Despite emerging evidence supporting the use of BFA in chronic pain, BFA has not been used to treat older adults with cLBP residing in CCRC. To this end, we propose an adapted group BFA protocol for CCRC residents. We will determine the feasibility and acceptability of implementing group BFA for cLBP at the University of Iowa (UI) Family Medicine-affiliated CCRCs by evaluating patient participation rates and retention, comfort with the protocol and satisfaction with the sessions, protocol delivery and ease of use. We will also determine treatment effectiveness by evaluating pain scales in cLBP, pain medication use, mobility, and falls. Data obtained from this study will inform the design of a future clinical trial testing group BFA for the management of cLBP in older adults.
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop taking your current medications. It seems to be designed to complement existing treatments, so you may not need to stop them.
What data supports the effectiveness of the treatment Battlefield Acupuncture for chronic lower back pain?
Research shows that Battlefield Acupuncture, a type of ear acupuncture, is effective for immediate pain relief in various settings, including military and civilian environments. It has been used successfully for pain management in veterans and is considered a low-risk alternative to traditional pain treatments.
12345Is Battlefield Acupuncture safe for humans?
Battlefield Acupuncture is considered very safe with a very low risk of adverse reactions, which are usually mild and temporary.
23456How is Battlefield Acupuncture different from other treatments for chronic lower back pain?
Battlefield Acupuncture is unique because it involves placing small needles in specific points on the ear to quickly relieve pain, and it can be performed by non-specialists, making it accessible in various settings. Unlike many pain treatments, it does not involve medication, reducing the risk of side effects and dependency.
23457Eligibility Criteria
This trial is for adults over 65 with chronic lower back pain who live at the Oaknoll Community Center and can move around (with or without help). They must be patients of UIHC. People with a history of battlefield acupuncture treatment or diagnosed dementia cannot participate.Inclusion Criteria
I have long-term lower back pain from a muscle or bone condition.
I am over 65 years old and live at the Oaknoll Community Center.
UIHC patient
+1 more
Exclusion Criteria
I have previously received BFA acupuncture treatment.
You have been diagnosed with dementia.
Anyone not meeting inclusion criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Data Collection
Participants receive weekly SMS prompts to report pain levels and other data for 12 weeks
12 weeks
Weekly SMS prompts
Treatment
Participants undergo group Battlefield Acupuncture sessions every other week
12 weeks
6 in-person sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests group Battlefield Acupuncture, an ear-based acupuncture method, to see if it helps older adults in retirement communities manage chronic lower back pain better than current treatments. It will look at how feasible and satisfying this approach is for participants.
1Treatment groups
Experimental Treatment
Group I: Acupuncture ArmExperimental Treatment3 Interventions
No control
Battlefield Acupuncture is already approved in United States for the following indications:
🇺🇸 Approved in United States as Battlefield Acupuncture for:
- Chronic pain
- Anxiety
- Insomnia
- Low back pain
- Headaches
- Arthritis
- Fibromyalgia
- Joint pain
- Hidradenitis suppurativa
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of IowaIowa City, IA
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Who Is Running the Clinical Trial?
Stephanie K. BuntLead Sponsor
Korey KenneltyLead Sponsor
References
Auricular acupuncture for chronic back pain in adults: a systematic review and metanalysis. [2022]To investigate randomized clinical trials on the action of auricular acupuncture for chronic back pain in adults, and to identify the most commonly used outcomes for assessing this condition, the protocol used for applying the intervention, and the efficacy of the therapy on pain intensity.
Patient Feedback on the Effectiveness of Auricular Acupuncture on Pain in Routine Clinical Care: The Experience of 11,406 Veterans. [2022]Veterans Health Administration (VHA) launched a national initiative to train providers in a specific, protocolized auricular acupuncture treatment (also called Battlefield Acupuncture or BFA) as a nonpharmacological approach to pain management. This evaluation assessed the real-world effectiveness of BFA on immediate pain relief and identified subgroups of patients for whom BFA is most effective.
Treating pain using acupuncture for nonacupuncturists. [2023]Battlefield acupuncture is a specific auricular acupuncture protocol that can be performed by nonacupuncturists in military and civilian clinical settings. Battlefield acupuncture is purported to be efficacious in controlling pain, is quickly administered, and requires minimal postadministration observation. With very low risk and a negligible adverse reaction profile, this technique can be used as an alternative or complement to manage pain. More large randomized controlled trials are needed to compare acupuncture with standard therapy in military and civilian settings.
Does Offering Battlefield Acupuncture Lead to Subsequent Use of Traditional Acupuncture? [2023]Veterans Health Administration encourages auricular acupuncture (Battlefield Acupuncture/BFA) as a nonpharmacologic approach to pain management. Qualitative reports highlighted a "gateway hypothesis": providing BFA can lead to additional nonpharmacologic treatments. This analysis examines subsequent use of traditional acupuncture.
Battlefield acupuncture to treat low back pain in the emergency department. [2019]Battlefield acupuncture (BFA) is an ear acupuncture protocol used by the military for immediate pain relief. This is a pilot feasibility study of BFA as a treatment for acute low back pain (LBP) in the emergency department (ED).
Battlefield Acupuncture for Adult Pain: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2021]Pain is a major public health problem, causing heavy social and economic burdens to patients and society while consuming tremendous medical resources at the same time. Thus, there is a critical need to find low-cost, efficacious, and therapeutic approaches to help manage pain. While acupuncture is increasingly recognized as a promising pain-relieving method, less is known about a specific form of auricular acupuncture known as Battlefield Acupuncture (BFA). The BFA technique involves the sequential placement of semi-permanent, single-use, French ASP[Formula: see text] golden needles to five specific acupoints in one or both ears, where they are left in place for 3-4 days or longer [Niemtzow, R.C., Battlefield acupuncture. Med. Acupunct. 19: 225-228, 2007]. The BFA needles (more accurately described as tiny conical darts) pierce the ear in designated locations in a particular order [Levy, C.E., N. Casler and D.B. FitzGerald. Battlefield acupuncture: an emerging method for easing pain. Am. J. Phys. Med. Rehabil. 97: e18-e19, 2018.]. (Figs. 4 and 5) It was developed by Dr. Richard C. Niemtzow in 2001, as a subgroup form of an auricular acupuncture technique based on the somatotopic arrangement of an inverted fetus pattern on the external ear [Romoli, M. Ear acupuncture: historical abstract-differences of ear cartography between the east and the west. Dtsch. Z. Akupunkt. 53: 24-33, 2010.]. Currently, BFA is widely used in the US military, but to our knowledge, there is no review which comprehensively synthesizes the current publications surrounding pain management. This review aims to investigate the effects and safety of BFA in adults with pain. Electronic databases were searched for randomized controlled trials (RCTs) published in English evaluating efficacy and safety of BFA in adults with pain, from database inception to September 6, 2019. The primary outcome was pain intensity change, and the secondary outcome was safety. Nine RCTs were included in this review, and five trials involving 344 participants were analyzed quantitatively. Compared with no intervention, usual care, sham BFA, and delayed BFA interventions, BFA had no significant improvement in the pain intensity felt by adults suffering from pain. Few adverse effects (AEs) were reported with BFA therapy, but they were mild and transitory. BFA is a safe, rapid, and easily learned acupuncture technique, mainly used in acute pain management, but no significant efficacy was found in adult individuals with pain, compared with the control groups. Given the poor methodological quality of the included studies, high-quality RCTs with rigorous evaluation methods are needed in the future.
Provider Perspectives of Battlefield Acupuncture: Advantages, Disadvantages and Its Potential Role in Reducing Opioid Use for Pain. [2022]Nonpharmacological options to treat pain are in demand, in part to address the opioid crisis. One such option is acupuncture. Battlefield acupuncture (BFA) is an auricular needling protocol currently used to treat pain in the Veterans Health Administration. We aimed to identify the advantages and disadvantages of BFA from providers' perspectives.