Sound Acupuncture in Painful Chemotherapy-Related Neuropathies (SUONO-PT 01)

September 16, 2025 updated by: Andrea Assini, Ente Ospedaliero Ospedali Galliera

Effectiveness of Sound Acupuncture in Painful Chemotherapy-Related Neuropathies: A Non-Invasive Alternative to Acupuncture? Pilot Study

The objective of this clinical trial is to evaluate the efficacy of sound acupuncture in combination with traditional medical therapy in the treatment of chemotherapy-induced peripheral neuropathies.

Sound acupuncture is a non-invasive technique that involves stimulating energy points, used in acupuncture, with the help of specific tuning forks and the frequencies they emit.

The energy points are those used in Chinese medicine and, more specifically, in acupuncture.

The aim is to restore the recipient's complex bioenergetic system to an optimal state of well-being and balance

Participants:

20 patients will receive only the best medical therapy; 20 patients will receive BMT and sound acupuncture treatment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Liguria
      • Genoa, Liguria, Italy, 16128
        • E.O. Ospedali Galliera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 30-80 years
  • Clinical and electrophysiological diagnosis of chemotherapy-induced neuropathy
  • Patients being treated with Best Medical Therapy for neuropathic pain
  • Written informed consent

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Patients with intellectual disabilities or cognitive impairment that impair their ability to comply with the consent process
  • Pacemaker users

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sound acupuncture
Best medical therapy + Sound Acupuncture
Other: Sound acupuncture
Best medical therapy + soundpuncture
No Intervention: BMT
Best medical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain reduction
Time Frame: 1 year
At least a 30% reduction from baseline on the NPS scale for neuropathic pain
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Back Depression inventory
Time Frame: 1 year
Effectiveness of sound therapy combined with pharmacological treatment through administration of the BDI-II scale
1 year
Quality of life assessment
Time Frame: 1 year
EQ-5D scale for assessing the impact on quality of life
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ente Ospedaliero Ospedali Galliera

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2022

Primary Completion (Actual)

July 15, 2025

Study Completion (Actual)

July 16, 2025

Study Registration Dates

First Submitted

August 4, 2025

First Submitted That Met QC Criteria

September 16, 2025

First Posted (Estimated)

September 23, 2025

Study Record Updates

Last Update Posted (Estimated)

September 23, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 67UCS2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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