Acupressure for Peripheral Neuropathy

Recruiting at 2 trial locations

Overseen By Nada Lukkahatai, PHD, MSN, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Investigational agents

Disqualifiers: Diabetic neuropathy, Pregnant, Latex allergy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

225 Participants Needed

Trial Summary

What is the purpose of this trial?

The proposed randomized control trial will evaluate auricular point acupressure (APA) on chemotherapy-induced neuropathy (CIN), rigorously considering point specificity and placebo effects by integrating self-report measures, psychophysical measures (QST), endogenous biomarkers (cytokines), and neuro-imaging to investigate APA's efficacy and underlying mechanism(s).

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you are using an investigational agent for pain control or have an implantable drug delivery system.

What data supports the effectiveness of the treatment Auricular Point Acupressure for Peripheral Neuropathy?

Research shows that Auricular Point Acupressure (APA) has been effective in reducing pain for conditions like chemotherapy-induced neuropathy and chronic low back pain. In a study on chronic low back pain, participants who received APA reported a 41% reduction in worst pain compared to only 5% in a sham group, suggesting potential benefits for managing peripheral neuropathy as well. ^{1 2 3 4 5}

Is auricular point acupressure safe for humans?

Auricular point acupressure (APA) is generally considered safe, with most reported side effects being mild and temporary, such as skin irritation, local discomfort, and dizziness. No serious adverse events have been identified in studies. ^{1 3 4 5 6}

How is the treatment Auricular Point Acupressure different from other treatments for peripheral neuropathy?

Auricular Point Acupressure (APA) is unique because it involves stimulating specific points on the ear without needles, unlike traditional acupuncture. This needleless approach is designed to manage symptoms like pain and discomfort, and has been studied for its effects on brain activity and pain relief in conditions like chemotherapy-induced neuropathy. ^{1 3 4 5 7}

Research Team

Constance Johnson, PhD, MS, RN

Principal Investigator

The University of Texas Health Science Center, Houston

Nada Lukkahatai, PHD, MSN, RN

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for cancer patients over 18 who've finished chemotherapy with specific drugs at least three months ago and are experiencing moderate to severe neuropathy pain or numbness. It's not for those using investigational pain agents, drug delivery implants, have latex allergies, prior neurolytic treatments, or pre-existing conditions causing similar symptoms.

Inclusion Criteria

I have been treated with specific cancer drugs like platinum or taxanes.

I finished my chemotherapy over three months ago.

I am 18 years old or older with cancer.

Exclusion Criteria

Allergy to latex (the tapes for the APA include latex)

I have had painful tingling in my limbs before chemotherapy due to other causes.

I have had a celiac plexus block or similar pain treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive auricular point acupressure (APA) or virtual APA (vAPA) for chemotherapy-induced neuropathy management

4 weeks

Weekly in-person or virtual sessions

Follow-up

Participants are monitored for changes in pain severity, numbness, tingling, and physical function

Up to 4 months

Treatment Details

Interventions

• Auricular Point Acupressure

Trial Overview The study tests Auricular Point Acupressure (APA) for managing chemotherapy-induced neuropathy. Participants will be randomly assigned to receive APA via a virtual app or in-person training, sham APA as a placebo control, or usual care without APA intervention.

Participant Groups

Group I: Virtual Auricular Point Acupressure (vAPA) Experimental Treatment 2 Interventions

The vAPA arm will self-administer APA by placing the seeds according to the video instruction found in the self-guided smartphone application for understanding and administering APA. Participant and/or a caregiver will follow the video instruction on seed placement and will receive one zoom session for APA coaching one week after the baseline visit.

Group II: Auricular Point Acupressure (APA) Experimental Treatment 2 Interventions

The APA arm will receive in-person weekly treatments and a self-guided smartphone application with videos for understanding and administering APA. The APA arm will receive one in-person seed placement and a training for the participant or their caregiver to place the seeds on the ear points, as well as one zoom meeting 1 week after the first visit to coach participant and/or caregiver on seed placement.

Group III: Usual Care Control Active Control 1 Intervention

Usual Care arm will continue with their usual care.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

University of Texas

Collaborator

Trials

193

Recruited

143,000+

Findings from Research

A systematic review of various studies found that adverse events from auricular therapy (AT) are generally mild and transient, with common issues including tenderness, dizziness, and local discomfort, but no serious adverse events were reported.

The study highlights the need for improved reporting of adverse events in future AT research, suggesting that while AT appears to be a safe treatment option, more comprehensive data collection is necessary to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of auricular therapy: a systematic review. Tan, JY., Molassiotis, A., Wang, T., et al.[2022]

References

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

Preliminary Effectiveness of Auricular Point Acupressure on Chemotherapy-Induced Neuropathy: Part 1 Self-Reported Outcomes. [2020]

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

Effects of auricular acupressure on pain and disability in adults with chronic neck pain. [2020]

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

Preliminary Effectiveness of Auricular Point Acupressure on Chemotherapy-Induced Neuropathy: Part 2 Laboratory-Assessed and Objective Outcomes. [2020]

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

Auricular point acupressure to manage chronic low back pain in older adults: a randomized controlled pilot study. [2021]

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

Dynamic Brain Activity Following Auricular Point Acupressure in Chemotherapy-Induced Neuropathy: A Pilot Longitudinal Functional Magnetic Resonance Imaging Study. [2022]

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

Adverse events of auricular therapy: a systematic review. [2022]

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

Effects of Auricular Point Acupressure on Pain Relief: A Systematic Review. [2022]