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Very Low Frequency Magnetic Fields Versus the Supplement "Xinepa" in the Treatment of the Carpal Tunnel Syndrome

NCT ID: NCT02891512

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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Carpal Tunnel Syndrome

Keywords

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Magnetic Fields Pain Paresthesia Visual Analogue Scale

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ELF and Xinepa®

The very low frequency magnetic fields (ELF) are magnetic fields already use for orthopedics pathology that have shown to be able to repair, to reduce pain, inflammation and edema in the damaged tissues. Xinepa® is a dietary supplement containing alpha-lipoic acid, N-acetyl-L-carnitine, turmeric, vitamins B, E and C. They have an antioxidant and anti-inflammatory action on nervous system and they act on cellular energy metabolism.

Group Type EXPERIMENTAL

ELF

Intervention Type OTHER

Very low frequency magnetic fields (ELF) at intensity of 100 mT and a frequency of 1-80 Hz. Protocol (antiedema-antinflammatory): 12 sessions, 3 times a week for 4 consecutive weeks, each session lasted 30 minutes.

Xinepa®

Intervention Type OTHER

2 tablets of Xinepa daily (morning and evening) for 1 month.

ELF and Placebo Xinepa®

The very low frequency magnetic fields (ELF) are magnetic fields already use for orthopedics pathology that have shown to be able to repair, to reduce pain, inflammation and edema in the damaged tissues. Xinepa® without its specific activity for the condition being treated.

Group Type PLACEBO_COMPARATOR

ELF

Intervention Type OTHER

Very low frequency magnetic fields (ELF) at intensity of 100 mT and a frequency of 1-80 Hz. Protocol (antiedema-antinflammatory): 12 sessions, 3 times a week for 4 consecutive weeks, each session lasted 30 minutes.

Placebo Xinepa®

Intervention Type OTHER

2 tablets of Xinepa placebo daily (morning and evening) for 1 month.

Interventions

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ELF

Very low frequency magnetic fields (ELF) at intensity of 100 mT and a frequency of 1-80 Hz. Protocol (antiedema-antinflammatory): 12 sessions, 3 times a week for 4 consecutive weeks, each session lasted 30 minutes.

Intervention Type OTHER

Xinepa®

2 tablets of Xinepa daily (morning and evening) for 1 month.

Intervention Type OTHER

Placebo Xinepa®

2 tablets of Xinepa placebo daily (morning and evening) for 1 month.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Teresa Paolucci

Medical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vincenzo Maria Saraceni

Role: STUDY_DIRECTOR

Umberto I hospital, Sapienza University of Rome

Locations

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Umberto I Hospital

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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2545/15

Identifier Type: -

Identifier Source: org_study_id