225 Participants Needed

Acupressure for Peripheral Neuropathy

Recruiting at 2 trial locations
CH
TS
CJ
NL
Overseen ByNada Lukkahatai, PHD, MSN, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.23456

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.23457

Who Is on the Research Team?

CJ

Constance Johnson, PhD, MS, RN

Principal Investigator

The University of Texas Health Science Center, Houston

NL

Nada Lukkahatai, PHD, MSN, RN

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 have nerve damage from chemotherapy or it worsened after treatment.
See 1 more

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.
See 2 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Virtual Auricular Point Acupressure (vAPA)Experimental Treatment2 Interventions
Group II: Auricular Point Acupressure (APA)Experimental Treatment2 Interventions
Group III: Usual Care ControlActive Control1 Intervention

Find a Clinic Near You

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+

Published Research Related to This Trial

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

Citations

Preliminary Effectiveness of Auricular Point Acupressure on Chemotherapy-Induced Neuropathy: Part 1 Self-Reported Outcomes. [2020]
Effects of auricular acupressure on pain and disability in adults with chronic neck pain. [2020]
Preliminary Effectiveness of Auricular Point Acupressure on Chemotherapy-Induced Neuropathy: Part 2 Laboratory-Assessed and Objective Outcomes. [2020]
Auricular point acupressure to manage chronic low back pain in older adults: a randomized controlled pilot study. [2021]
Dynamic Brain Activity Following Auricular Point Acupressure in Chemotherapy-Induced Neuropathy: A Pilot Longitudinal Functional Magnetic Resonance Imaging Study. [2022]
Adverse events of auricular therapy: a systematic review. [2022]
Effects of Auricular Point Acupressure on Pain Relief: A Systematic Review. [2022]
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