Acupuncture for Chronic Pain

(PEACE Trial)

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

360 Participants Needed

Trial Summary

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 data supports the effectiveness of acupuncture as a treatment for chronic pain?

Some studies suggest that acupuncture can help with chronic pain, especially for conditions like musculoskeletal disorders and osteoarthritis. However, the evidence is mixed, and more high-quality research is needed to confirm its effectiveness compared to placebo or other treatments. ^{1 2 3 4 5}

Is acupuncture safe for treating chronic pain?

Research suggests that acupuncture, including battlefield acupuncture and electro-acupuncture, is generally safe for treating pain, with no severe adverse events reported in studies. However, more high-quality studies are needed to confirm its safety across diverse settings and populations. ^{6 7 8 9 10}

How does the treatment of Battlefield Acupuncture and Electro-Acupuncture for chronic pain differ from other treatments?

Battlefield Acupuncture and Electro-Acupuncture are unique because they involve stimulating specific points on the body with needles, sometimes using electrical currents, to relieve pain. Unlike conventional pain medications, these treatments focus on enhancing the body's natural pain-relief mechanisms and have shown effectiveness in reducing pain intensity and improving quality of life without the side effects associated with drugs. ^{2 11 12 13 14}

What is the purpose of this trial?

The purpose of this study is to compare two types of acupuncture with usual care on treating chronic pain. This study has three groups. Two groups will received acupuncture. One group will receive usual standard of care for 12 weeks and then will receive acupuncture. Acupuncture is an ancient Chinese technique of using very thin needles inserted in the skin to treat different symptoms and illness, and to promote healing. Each group will undergo a different method of needle administration.

Research Team

Jun Mao, MD, MSCE

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Acupuncture analgesia. I. Review of clinical studies. [2019]

2. Canada pubmed.ncbi.nlm.nih.gov

The results of therapeutic acupuncture in a pain clinic. [2019]

3. Singapore pubmed.ncbi.nlm.nih.gov

Acupuncture and chronic pain management. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Acupuncture for chronic pain. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Is acupuncture effective for the treatment of chronic pain? A systematic review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Battlefield Acupuncture as a Treatment for Pain. [2021]

7. Netherlands 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Treating pain using acupuncture for nonacupuncturists. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Battlefield Acupuncture: Is It Ready for Widespread Dissemination? [2018]

10. England pubmed.ncbi.nlm.nih.gov

Adverse events related to electroacupuncture: a systematic review of single case studies and case series. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Electroacupuncture May Improve Burning and Electric Shock-Like Neuropathic Pain: A Prospective Exploratory Pilot Study. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

The short- and long-term benefit in chronic low back pain through adjuvant electrical versus manual auricular acupuncture. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Incidence of prolonged pain relief following acupuncture. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis. [2022]