Sound Acupuncture in Painful Chemotherapy-Related Neuropathies (SUONO-PT 01)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Liguria
-
Genoa, Liguria, Italy, 16128
- E.O. Ospedali Galliera
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
|
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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