Electroacupuncture for Neuropathic Pain

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen by Ting Bao, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Pacemaker, Acupuncture past year, others

Trial Summary

What is the purpose of this trial?

This trial is testing if electroacupuncture, which uses needles and a small electrical current, can help reduce pain in cancer survivors who have pain from chemotherapy. Electroacupuncture has been studied for its potential to relieve cancer pain and improve quality of life in cancer patients.

Will I have to stop taking my current medications?

The trial requires that you stay on a stable regimen of your current pain medications, meaning you should not change your medication routine if you are already taking anti-neuropathy or other pain medications. You also cannot start any new pain medications during the first 12 weeks of the study.

What data supports the effectiveness of electroacupuncture for neuropathic pain?

Research suggests that electroacupuncture can significantly reduce pain intensity and improve quality of life for patients with neuropathic pain, as shown by a study where patients experienced a 46.7% reduction in pain intensity after eight sessions. Additionally, both acupuncture and TENS have been shown to help manage various types of pain by activating the body's natural pain control systems. ^{1 2 3 4 5}

Is electroacupuncture generally safe for humans?

Electroacupuncture is generally considered safe when performed by trained professionals, but like other forms of acupuncture, it can have some risks. These include minor issues like local reactions or dizziness, and very rarely, more serious problems like infections or organ injuries. It's important to ensure that the practitioner follows proper safety guidelines, such as using clean needles. ^{6 7 8 9 10}

How does electroacupuncture differ from other treatments for neuropathic pain?

Electroacupuncture is unique because it combines traditional acupuncture with electrical stimulation to reduce neuropathic pain by inhibiting astrocyte activation in the spinal cord, which is different from conventional drug treatments. It has shown promise in reducing pain intensity and improving psychosocial and functional outcomes, particularly for burning and electric shock-like pain. ^{1 3 11 12 13}

Research Team

Ting Bao, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for English-speaking adults over 18 who have completed certain chemotherapy treatments at least three months ago and are experiencing nerve pain from it. They must not start any new pain medications during the first 12 weeks of the study and should be free of cancer as confirmed by exams and history.

Inclusion Criteria

I am 18 or older and speak English well.

I have moderate to severe nerve pain from chemotherapy, scoring 4 or more on a pain scale.

I have been diagnosed with CIPN due to symptoms like pain, numbness, or tingling in a pattern that fits like gloves or socks.

Exclusion Criteria

Patients with a pacemaker or other electronically charged medical device

I have used acupuncture for symptom management in the last year.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 electroacupuncture or sham acupuncture treatments over 8 weeks

8 weeks

Follow-up

Participants are monitored for changes in pain severity and other CIPN-related symptoms

4 weeks

Treatment Details

Interventions

• Acupuncture (Behavioural Intervention)
• Electroacupuncture (Behavioural Intervention)

Trial Overview The study is testing whether electroacupuncture (EA), which combines acupuncture with electrical stimulation, can reduce nerve pain caused by chemotherapy. Participants will be randomly assigned to receive either EA or sham acupuncture, which does not involve electrical stimulation.

Participant Groups

Group I: Electroacupuncture Arm Experimental Treatment 1 Intervention

The study participants will include 250 cancer survivors who have completed neurotoxic agent containing chemotherapy at least three months prior and have persistent moderate to severe Chemotherapy-Induced Peripheral Neuropathy/CIPN pain randomized to one of two study arms.

Group II: Sham Acupuncture Arm Placebo Group 1 Intervention

The study participants will include 250 cancer survivors who have completed neurotoxic agent containing chemotherapy at least three months prior and have persistent moderate to severe Chemotherapy-Induced Peripheral Neuropathy/CIPN pain randomized to one of two study arms.

Acupuncture is already approved in China for the following indications:

Approved in China as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression
• Neuropathy

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Dr. Benjamin L. Ebert

Dana-Farber Cancer Institute

Chief Executive Officer

MD from Harvard Medical School, PhD from Oxford University

Dr. Craig A. Bunnell

Dana-Farber Cancer Institute

Chief Medical Officer since 2012

MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management

Memorial Sloan Kettering Cancer Center

Collaborator

Trials

1,998

Recruited

602,000+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University

Findings from Research

This study will evaluate the effectiveness and safety of electroacupuncture combined with conventional medicine for treating intractable neuropathic pain in 40 patients, who have been experiencing pain despite standard treatment for over 3 months.

The primary outcome will assess changes in pain levels and overall pain impact after 6 weeks, providing valuable evidence on whether adding electroacupuncture improves outcomes compared to conventional treatment alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an effectiveness and safety of the electroacupuncture in the management of intractable neuropathic pain: A prospective, open-labeled, randomized, cross-over clinical trial. Moon, JY., Lee, CS., Yoo, Y., et al.[2021]

Recent studies indicate that acupuncture and transcutaneous electrical nerve stimulation (TENS) are effective non-pharmacological methods for pain relief, showing benefits over conventional treatments in various types of pain.

Both acupuncture and TENS have mechanisms of action that involve the body's own pain control systems and have no reported serious adverse effects, supporting their use in managing chronic pain when medications are insufficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-pharmacological treatments for pain relief: TENS and acupuncture. Coutaux, A.[2022]

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]

The review found that the evidence for the effectiveness of various pain management techniques, including acupuncture and electrical nerve stimulation, was generally inadequate and based on studies with poor methodologies.

One randomized controlled trial suggested that electrical nerve stimulation may provide limited pain relief for myofascial pain syndrome for up to 4 weeks, but more research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture, transcutaneous electrical nerve stimulation, and laser therapy in chronic pain. Fargas-Babjak, A.[2019]

Transcutaneous electrical nerve stimulation (TENS) and spinal cord stimulation (SCS) were found to effectively reduce pain across various models of neuropathic, inflammatory, and non-inflammatory pain in rats, indicating their broad efficacy as pain management techniques.

Manual acupuncture (MA) was effective in increasing pain thresholds for neuropathic and inflammatory pain but did not show effectiveness for chronic muscle pain, suggesting that its benefits may be more limited compared to TENS and SCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation, acupuncture, and spinal cord stimulation on neuropathic, inflammatory and, non-inflammatory pain in rat models. Sato, KL., Sanada, LS., Silva, MDD., et al.[2022]

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]

Acupuncture can lead to adverse events (AEs), including organ or tissue injuries, infections, local reactions, and other complications, with serious AEs being rare but potentially life-threatening, as highlighted by a review of 17 systematic reviews.

The overall methodological quality of the reviews on acupuncture AEs was mediocre, indicating a need for improved research standards and emphasizing the importance of patient safety and acupuncturist training in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Acupuncture: Overview of Systematic Reviews. Chan, MWC., Wu, XY., Wu, JCY., et al.[2022]

A review of 23 observational studies on acupuncture-related adverse events revealed that many did not provide sufficient information to determine the cause of complications, highlighting a gap in reporting quality.

The study emphasizes the need for better involvement of acupuncture experts in reporting adverse events to improve the understanding and safety of acupuncture practices, particularly regarding infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Reporting Quality of Acupuncture-Related Infections in Korean Literature: A Systematic Review of Case Studies. Kim, TH., Kang, JW., Park, WS.[2022]

A review of adverse events (AEs) from acupuncture, moxibustion, and cupping between 2000 and 2011 identified 308 AEs, with infections being the most common complication, particularly bacterial infections from skin contact at acupoint sites.

The study highlights the importance of following safety guidelines, like the Clean Needle Technique, to minimize the risk of infections during acupuncture, as previous concerns about hepatitis from reusable needles were not found in this review.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of acupuncture: a systematic review of case reports. Xu, S., Wang, L., Cooper, E., et al.[2022]

Electroacupuncture (EA) significantly alleviated neuropathic pain in a rat model of brachial plexus neuralgia (BPN), with the most effective results observed when treatment started on postoperative day 1, as indicated by increased mechanical withdrawal thresholds.

EA treatment also reduced inflammation and reversed demyelination in the brachial plexus and cervical cord, suggesting a potential mechanism for its analgesic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic Effects and Neuropathology Changes of Electroacupuncture on Curing a Rat Model of Brachial Plexus Neuralgia Induced by Cobra Venom. Liu, H., Qian, XY., An, JX., et al.[2018]

A systematic review of 15 studies involving 724 participants found that transcutaneous electrical nerve stimulation (TENS) showed a statistically significant reduction in pain intensity compared to sham TENS, but the quality of evidence was rated as very low, indicating uncertainty about its effectiveness.

While TENS was associated with minor adverse events like skin irritation, the overall evidence regarding its efficacy compared to usual care or other treatments was inconclusive, with many studies showing no significant differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) for neuropathic pain in adults. Gibson, W., Wand, BM., O'Connell, NE.[2022]

Electroacupuncture (EA) effectively reduces neuropathic pain by inhibiting astrocyte activation in the spinal cord, as demonstrated in a chronic pain model.

The study found that blocking adenosine A1 receptors with DPCPX reversed the pain-relieving effects of EA, highlighting the importance of this receptor in the mechanism of acupuncture analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Involvement of adenosine A1 receptor in electroacupuncture-mediated inhibition of astrocyte activation during neuropathic pain. Zhang, M., Dai, Q., Liang, D., et al.[2019]

References

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

Evaluation of an effectiveness and safety of the electroacupuncture in the management of intractable neuropathic pain: A prospective, open-labeled, randomized, cross-over clinical trial. [2021]

2. France pubmed.ncbi.nlm.nih.gov

Non-pharmacological treatments for pain relief: TENS and acupuncture. [2022]

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

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

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

Acupuncture, transcutaneous electrical nerve stimulation, and laser therapy in chronic pain. [2019]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation, acupuncture, and spinal cord stimulation on neuropathic, inflammatory and, non-inflammatory pain in rat models. [2022]

6. England pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Safety of Acupuncture: Overview of Systematic Reviews. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China. [2021]

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

The Reporting Quality of Acupuncture-Related Infections in Korean Literature: A Systematic Review of Case Studies. [2022]

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

Adverse events of acupuncture: a systematic review of case reports. [2022]

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

Analgesic Effects and Neuropathology Changes of Electroacupuncture on Curing a Rat Model of Brachial Plexus Neuralgia Induced by Cobra Venom. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) for neuropathic pain in adults. [2022]

13. Germany pubmed.ncbi.nlm.nih.gov

Involvement of adenosine A1 receptor in electroacupuncture-mediated inhibition of astrocyte activation during neuropathic pain. [2019]