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Clinical Trials/NCT07187986
NCT07187986CompletedNot Applicable

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

Ente Ospedaliero Ospedali Galliera1 site in 1 country40 target enrollmentStarted: March 17, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Pain reduction

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
30 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Sound acupuncture

Experimental

Best medical therapy + Sound Acupuncture

Intervention: Sound acupuncture (Other)

BMT

No Intervention

Best medical therapy

Outcomes

Primary Outcomes

Pain reduction

Time Frame: 1 year

At least a 30% reduction from baseline on the NPS scale for neuropathic pain

Secondary Outcomes

  • Back Depression inventory(1 year)
  • Quality of life assessment(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Andrea Assini

MD

Ente Ospedaliero Ospedali Galliera

Study Sites (1)

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