Effectiveness of Very Low Frequency Magnetic Fields Versus the Supplement "Xinepa" in the Treatment of the Carpal Tunnel Syndrome: Randomized Double-blind Controlled Clinical Trial.

University of Roma La Sapienza1 site in 1 country31 target enrollmentJuly 2015

ConditionsCarpal Tunnel Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Carpal Tunnel Syndrome
Sponsor: University of Roma La Sapienza
Enrollment: 31
Locations: 1
Primary Endpoint: Change of Visual Analogue Scale (VAS) from baseline to 12 weeks
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to determine the effectiveness of the treatment with very low frequency magnetic fields (ELF) on the reduction of pain and the relief of the associated signs such as sensitivity disorders that affect the first three fingers and half of the fourth finger of the hand in patients with carpal tunnel syndrome versus the supplement (= Xinepa).

Registry

clinicaltrials.gov

Start Date

July 2015

End Date

January 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Roma La Sapienza

Responsible Party

Principal Investigator

Teresa Paolucci

Medical Director

University of Roma La Sapienza

Eligibility Criteria

Inclusion Criteria

•Diagnosis of carpal tunnel syndrome

Exclusion Criteria

•Pregnancy;
•Pacemaker or other metallic implants;
•Systemic infectious disorders;
•Neoplastic disorders;
•Epilepsy;
•Severe heart disease.
•Known hypersensitivity to the components of Xinepa

Outcomes

Primary Outcomes

Change of Visual Analogue Scale (VAS) from baseline to 12 weeks

Time Frame: baseline, 4 weeks, 12 weeks

It is a scale for the assessment of pain and it's based on a ten point scale, where 0 means no pain and 10 the greatest pain ever both at rest and during movements.

Secondary Outcomes

Change of Boston Carpal Tunnel Questionnaire from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
Change of the measurement of the grip strength trough the Jamar dynamometer from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
Change of Semmes-Weinstein Monofilaments of light touch and pressure sensation test from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
Change of the measurement of the pinch strength trough the Pinch Gauges dynamometer from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
Change of electroneurography from baseline to 12 months(baseline, 4 weeks, 12 weeks)