Acupuncture for Chronic Pain

(PEACE Trial)

Not currently recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Disease modifying drugs

Disqualifiers: Non-musculoskeletal pain, Inflammatory arthritis, Metastatic cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two types of acupuncture—Battle Field Acupuncture and Electro-Acupuncture—with regular care in treating chronic pain. Participants will receive one of these acupuncture treatments or continue their usual care for 12 weeks before trying acupuncture. It is suitable for English-speaking adults who have experienced musculoskeletal pain (pain in muscles, joints, or bones) for at least three months and feel pain on most days. As an unphased trial, this study provides a unique opportunity to explore alternative pain management options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these acupuncture methods are safe for treating chronic pain?

Research shows that both Electro-Acupuncture (EA) and Battle Field Acupuncture (BFA) are generally safe for relieving pain. Studies on Electro-Acupuncture indicate it is well-tolerated, with no serious side effects reported. This treatment has been used for various types of pain, such as long-term low back pain and nerve pain, without major issues.

Similarly, research on Battle Field Acupuncture suggests it is a safe method for pain treatment. Most patients experience reduced pain, and importantly, no serious side effects have been reported. This makes BFA a promising and safe option for managing pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for chronic pain because they offer unique approaches compared to standard options like medications and physical therapy. Battle Field Acupuncture (BFA) uses a specific ear acupuncture technique believed to provide rapid pain relief, which could be a game-changer for those experiencing intense discomfort. Meanwhile, Electro-Acupuncture (EA) combines traditional acupuncture with electrical stimulation, potentially enhancing pain reduction and improving overall effectiveness. These alternative methods could provide patients with non-drug options, reducing reliance on pain medications and their associated side effects.

What evidence suggests that this trial's acupuncture treatments could be effective for chronic pain?

Research has shown that electro-acupuncture (EA), one of the treatments in this trial, can alleviate chronic pain. Studies have found that EA reduces pain in conditions like osteoarthritis and long-term muscle pain. Patients often experience less pain and achieve better results compared to those receiving standard treatment.

Battlefield acupuncture (BFA), another treatment option in this trial, also shows promise for managing chronic pain. It has effectively provided quick pain relief, especially for veterans. Research highlights that it can reduce pain more effectively than usual care methods. Both EA and BFA combine traditional techniques with modern methods to help manage chronic pain. ^{1 4 6 7 8}

Who Is on the Research Team?

Jun Mao, MD, MSCE

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Adults over 18 with chronic pain for at least 3 months, experiencing significant pain levels, and have musculoskeletal issues like fibromyalgia. Cancer patients can join if they've finished active treatment a month prior but not if they have metastatic disease. Excludes those with inflammatory arthritis on specific drugs, non-musculoskeletal sole pain conditions, phantom limb pain, electronic medical implants or pending disability claims.

Inclusion Criteria

I finished my cancer treatment (except hormone therapy) over a month ago.

I have experienced pain for at least 3 months, with pain on at least 15 days in the last month.

I have cancer, but it has not spread to distant parts of my body.

Exclusion Criteria

I take medication for inflammatory arthritis like rheumatoid arthritis.

I have a primary musculoskeletal pain condition, even if I also have other types of pain like headaches or abdominal pain.

Have a pending pain-related VA or social security or worker's comp disability claim by self-report

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 treatments of either Electro-Acupuncture or Battle Field Acupuncture over 10 weeks

10 weeks

Up to 2 visits per week

Wait List Control

Participants receive usual standard of care for 12 weeks before receiving acupuncture

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Battle Field Acupuncture
• Electro-Acupuncture
• Wait List Control

Trial Overview The PEACE trial is testing two acupuncture techniques against standard care in managing chronic pain. Participants are divided into three groups: one receives Electro-Acupuncture (EA), another Battle Field Acupuncture (BFA), and the third group gets usual care before later receiving acupuncture.

How Is the Trial Designed?

Group I: Electro-Acupuncture (EA) Procedure Active Control 1 Intervention

Participants will receive 10 treatment of EA acupuncture over the course of 10 weeks (with a maximum of 2 treatments per week).

Group II: Battle Field Acupuncture (BFA) Procedure Active Control 1 Intervention

Participants will receive 10 treatment of BFA acupuncture over the course of 10 weeks (with a maximum of 2 treatments per week).

Group III: Wait List Control (WLC) Usual Care Procedure Active Control 3 Interventions

Subjects in the WLC group continue to receive their standard medical care and pain management as prescribed by their physicians or other health care providers, including analgesic medications. After the 12 week follow up period, patients in the WLC will receive up to ten treatments of either EA or BFA based on their personal preference.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

Battlefield acupuncture, a form of auricular acupuncture, shows promise for treating both acute and chronic pain, with 12 studies involving a total of 12,326 participants indicating positive outcomes, especially in nonrandomized trials.

While no severe adverse events were reported, many randomized trials had a high risk of bias due to lack of blinding, suggesting that more rigorous studies are needed to confirm its efficacy and safety before widespread adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Battlefield Acupuncture as a Treatment for Pain. Salamone, FJ., Federman, DG.[2021]

Auricular electroacupuncture (EA) significantly relieves chronic low back pain more effectively than conventional manual acupuncture, as shown in a study with 61 patients over 6 weeks, leading to better pain relief and improved psychological well-being.

Patients receiving EA also reported less need for analgesic medication and had better activity levels and sleep quality, with no adverse side effects noted, indicating it is a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The short- and long-term benefit in chronic low back pain through adjuvant electrical versus manual auricular acupuncture. Sator-Katzenschlager, SM., Scharbert, G., Kozek-Langenecker, SA., et al.[2019]

Battlefield acupuncture is a quick and effective pain management technique that can be performed by nonacupuncturists, making it accessible in both military and civilian healthcare settings.

This method has a very low risk of adverse reactions, suggesting it can be safely used as an alternative or complement to traditional pain management therapies, although more large randomized controlled trials are needed to confirm its efficacy compared to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating pain using acupuncture for nonacupuncturists. Toney, B.[2023]

A systematic review of 37 studies on electroacupuncture (EA) identified various adverse events (AEs), with common issues including pallor, skin pigmentation, and vertigo, highlighting the need for awareness of these potential side effects in clinical practice.

While most patients (62%) fully recovered from AEs related to EA, there were serious incidents reported, including three deaths, indicating that although EA can be beneficial, it carries risks that require careful monitoring and reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events related to electroacupuncture: a systematic review of single case studies and case series. Park, JH., Lee, JH., Lee, S., et al.[2021]

In a study involving 165 breast cancer survivors, electro-acupuncture (EA) significantly reduced pain severity more than battlefield auricular acupuncture (BFAA) at both 12 and 24 weeks, indicating EA may be a more effective treatment for chronic musculoskeletal pain.

Both EA and BFAA improved physical and mental health scores compared to usual care, suggesting that while EA is superior for pain relief, both methods are beneficial for overall well-being in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electro-acupuncture versus battle field auricular acupuncture in breast cancer survivors with chronic musculoskeletal pain: subgroup analysis of a randomized clinical trial. Bao, T., Zhi, WI., Baser, RE., et al.[2023]

In a pilot study involving 22 patients with chronic neuropathic pain, electroacupuncture (EA) significantly reduced pain intensity by 46.7% after 4 weeks of treatment, indicating its potential effectiveness as an add-on therapy.

Patients reported improvements in specific pain types, such as burning and electric shock-like pain, along with enhanced psychosocial well-being, suggesting that EA not only alleviates pain but also improves quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroacupuncture May Improve Burning and Electric Shock-Like Neuropathic Pain: A Prospective Exploratory Pilot Study. Lee, S., Lee, CS., Moon, JY., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7044765/

Battlefield Acupuncture for Chronic Pain Management in ... In a 3-month postdeployment survey sample of 2597 soldiers who had served in Afghanistan and Iraq, 44% reported pain lasting for more than 3 months, half of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12094825/

Practical Applications and Safety of Battlefield Acupuncture for ... Battlefield acupuncture (BFA) integrates traditional Chinese medicine with contemporary military medicine, achieving a rapid analgesic effect.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2213422024000209

How does pretreatment expectancy influence pain ... We analyzed data from a randomized clinical trial that compared EA and BFA versus wait list control (WLC) for chronic musculoskeletal pain in cancer survivors.

4. hsrd.research.va.gov hsrd.research.va.gov/research/citations/pubbriefs/articles.cfm?RecordID=938

Battlefield Acupuncture Proves Highly Effective in Treating ... Battlefield Acupuncture Proves Highly Effective in Treating Chronic Pain among Veterans ... BACKGROUND: Among the 5.7 million unique patients seen annually within ...

5. frontiersin.org frontiersin.org/journals/pain-research/articles/10.3389/fpain.2023.1279420/full

Battlefield acupuncture for chronic musculoskeletal pain in ... This is a secondary analysis of a randomized trial that compared the effectiveness of BFA and electroacupuncture vs. usual care for chronic musculoskeletal ...

6. research.va.gov research.va.gov/currents/0821-Battlefield-acupuncture.cfm

Battlefield acupuncture The research found that a high proportion of patients benefited, with more than 75 percent of them reporting some immediate decrease in pain ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05417724

Utilizing Battlefield Acupuncture(BFA) to Treat Chronic ... This research study will evaluate the effectiveness of utilizing Battlefield Acupuncture (BFA) on homeless and at risk for homelessness veterans with chronic ...

8. sma.org sma.org/southern-medical-journal/article/battlefield-acupuncture-as-a-treatment-for-pain/

Battlefield Acupuncture as a Treatment for Pain | SMJ No severe adverse events were reported. Clinicians may consider battlefield acupuncture as a safe treatment for pain while the evidence base grows; however, we ...