Electroacupuncture for Neuropathic Pain

Recruiting at 8 trial locations

Overseen By Natalie Viyaran

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Pacemaker, Acupuncture past year, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores acupuncture treatments to determine if they can manage nerve pain caused by chemotherapy in cancer survivors. Participants will receive either electroacupuncture, which uses mild electrical currents, or a placebo version to compare effects on pain relief. It is ideal for cancer survivors who completed chemotherapy at least three months ago and still experience significant nerve pain. Participants must not have changed pain medication in the past three months and should be willing to adhere to the study's requirements. As an unphased trial, this study offers a unique opportunity for patients to explore alternative pain management options and contribute to valuable research.

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 prior data suggests that electroacupuncture is safe for treating neuropathic pain?

Research has shown that electroacupuncture (EA) is generally well-tolerated by patients. Studies have found it to be a safe option for managing nerve pain caused by chemotherapy, known as chemotherapy-induced peripheral neuropathy (CIPN). In trials, patients using EA reported less pain without significant side effects, suggesting that EA can help manage pain without affecting overall health.

Additionally, electroacupuncture has been tested in various settings and consistently demonstrates a good safety record. Patients did not report major side effects, making it a promising treatment choice for those experiencing CIPN pain after chemotherapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about electroacupuncture for treating Chemotherapy-Induced Peripheral Neuropathy (CIPN) because it offers a non-drug approach that could provide relief without the side effects of medications like gabapentin or duloxetine. Unlike standard treatments that primarily focus on symptom management, electroacupuncture may work by directly stimulating nerves and improving blood flow to reduce pain. This technique offers a promising alternative for those who find little relief from or are unable to tolerate conventional drug therapies. Additionally, electroacupuncture's potential to enhance nerve function could lead to long-term benefits, setting it apart from other temporary pain relief methods.

What evidence suggests that electroacupuncture is effective for Chemotherapy-Induced Peripheral Neuropathy pain?

Research shows that electroacupuncture (EA), which participants in this trial may receive, can help relieve pain from chemotherapy-induced peripheral neuropathy (CIPN). A review of several studies has found that EA can reduce CIPN symptoms, including pain. Although some studies report mixed results, EA has proven effective for other types of nerve pain, such as diabetic neuropathy and post-shingles pain, suggesting it could also help with CIPN. EA stimulates nerves to reduce pain signals, potentially managing ongoing pain for cancer survivors. Overall, current evidence supports EA as a possible treatment to ease CIPN pain. ^{1 3 6 7 8}

Who Is on the Research Team?

Ting Bao, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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 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.

I am willing to follow all study procedures and accept any of the acupuncture treatments.

Exclusion Criteria

Patients with a pacemaker or other electronically charged medical device

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Acupuncture
• Electroacupuncture

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.

How Is the Trial Designed?

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 United States, European Union, China for the following indications:

Approved in United States as Acupuncture for:

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

Approved in European Union as Acupuncture for:

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

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+

Memorial Sloan Kettering Cancer Center

Collaborator

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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 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 1968 patients across three multicenter randomized controlled trials, only 3.76% experienced adverse events from acupuncture, indicating a low risk associated with this therapy.

The most common adverse events were minor, such as subcutaneous haematoma and needle site pain, and all but one patient recovered within two weeks, suggesting acupuncture is generally safe when performed by skilled practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China. Zhao, L., Zhang, FW., Li, 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04917796

NCT04917796 | The Effect of Electroacupuncture on Nerve ... The purpose of this study is to learn if EA can improve CIPN pain in cancer survivors, and if it is effective against other CIPN-related symptoms. Official ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9366109/

Efficacy of electroacupuncture with different frequencies in ... A systematic review and meta-analysis of the efficacy of acupuncture and electroacupuncture against chemotherapy-induced peripheral neuropathy.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1524904224003084

Peripheral Percutaneous Electrical Nerve Stimulation for ... We conducted a systematic search for randomised clinical trials evaluating the effectiveness of PENS on pain intensity, sleep quality, oral analgesic intake and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4924571/

Randomized sham controlled pilot trial of weekly electro ... In a randomized, sham-controlled trial of EA for prevention of taxane-induced CIPN, there were no differences in pain or neuropathy between groups at week 12.

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-14-254

Electroacupuncture for chemotherapy-induced peripheral ... Electroacupuncture (EA) has been found to be effective in treating diabetic peripheral neuropathy [10], neuropathic pain including post-herpetic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3751258/

Electroacupuncture for chemotherapy-induced peripheral ... This randomized controlled clinical trial is designed to evaluate the effects and safety of electroacupuncture (EA) for patients with CIPN.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12372149/

Percutaneous Peripheral Nerve Stimulation in Chemotherapy ... Conclusions: PENS may offer an effective and safe therapeutic option for managing CIPN, enabling symptom control without compromising ...

8. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.843886/full

Efficacy of electroacupuncture with different frequencies in ... This trial aims to evaluate the therapeutic effect of different frequencies of EA on CIPN in patients with cancer.