Acupressure for Peripheral Neuropathy

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of auricular point acupressure, a technique applying pressure on ear points, for relieving chemotherapy-induced neuropathy, which causes pain, tingling, or numbness in the hands and feet. The trial compares regular in-person treatments and virtual self-guided treatments using videos against usual care. It is open to cancer patients experiencing worsening peripheral neuropathy (nerve damage) after chemotherapy, with significant pain or numbness. Participants will determine whether this non-invasive treatment can improve their symptoms. As an unphased trial, it offers patients the chance to explore innovative, non-invasive treatment options that could enhance their quality of life.

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 prior data suggests that auricular point acupressure is safe for treating chemotherapy-induced neuropathy?

Research has shown that auricular point acupressure (APA), which involves applying pressure to specific points on the ear, is safe for managing symptoms such as diabetic and chemotherapy-induced nerve pain. In these studies, participants generally tolerated APA well. For instance, one study examined APA's effects on chemotherapy-induced nerve pain and found it safe, with no major side effects. Another study focused on diabetic nerve pain and suggested that APA did not cause harmful side effects while improving patient outcomes.

While these findings are encouraging, individual experiences may vary. Participants reported minimal discomfort, mainly related to the placement of seeds on the ear, which was usually mild and temporary. Overall, APA appears to be a safe option for managing nerve pain symptoms, with few reported side effects in previous research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Auricular Point Acupressure (APA) for peripheral neuropathy because it offers a non-invasive, drug-free approach to managing symptoms, unlike traditional options like medications or nerve blocks. This treatment involves applying pressure to specific points on the ear, which is believed to stimulate nerve pathways and alleviate discomfort. The virtual version, vAPA, further sets itself apart by allowing patients to self-administer treatments using a smartphone app, making it highly accessible and convenient. Both versions of APA provide a unique, holistic alternative that could enhance patient quality of life without the side effects often associated with standard care.

What evidence suggests that auricular point acupressure is effective for chemotherapy-induced neuropathy?

Research has shown that auricular point acupressure (APA) may help manage chemotherapy-induced neuropathy (CIN). Studies have found that APA can improve brain connections, potentially reducing neuropathy symptoms. Participants who received APA reported feeling better, and tests showed improved touch sensitivity and grip strength. In this trial, some participants will receive APA through in-person weekly treatments, while others will use Virtual APA (vAPA), self-administering APA with a smartphone app. Virtual APA has also demonstrated potential benefits, including changes in brain function linked to symptom relief. These findings suggest that both APA and vAPA could be helpful for people dealing with CIN. ^{1 2 4 6 7}

Who Is on the 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

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.

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 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?

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+

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11426428/

A randomized controlled study of auricular point acupressure ... The fMRI data taken after 10 minutes of APA indicated an increased brain functional connectivity between the salience and basal ganglia networks ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04920097

NCT04920097 | Auricular Point Acupressure to Manage ... The proposed randomized control trial will evaluate auricular point acupressure (APA) on chemotherapy-induced neuropathy (CIN), rigorously considering point ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1524904218302522

Preliminary Effectiveness of Auricular Point Acupressure ... Participants received four weeks of APA to manage their CIN. The laboratory-assessed and objective outcomes included quantitative sensory testing, grip and ...

4. apm.amegroups.org apm.amegroups.org/article/view/58991/html

Efficacy and safety of auricular acupressure for chemotherapy ... Preliminary effectiveness of auricular point Acupressure on chemotherapy-induced neuropathy: Part 1 self-reported outcomes. Pain Manag Nurs 2019;20:614-22 ...

5. academic.oup.com academic.oup.com/painmedicine/article/26/9/515/8098058

Auricular point acupressure for older adults with chronic low ... Preliminary effectiveness of auricular point acupressure on chemotherapy-induced neuropathy: part 2 laboratory-assessed and objective outcomes.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1550830725001557

Effect of auricular acupressure on neuropathy symptoms ... Diabetic peripheral neuropathy (DPN) is a common complication of diabetes, often leading to pain, disability, and reduced quality of life (QoL).

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7019394/

Dynamic Brain Activity Following Auricular Point Acupressure ... The objective of this study was to investigate the dynamic brain activity following auricular point acupressure (APA) in chemotherapy-induced neuropathy (CIN).