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

University of Roma La Sapienza

Status: Completed

Conditions: Carpal Tunnel Syndrome

Treatments: Other: Placebo Xinepa®; Other: Xinepa®; Other: ELF

Study type: Interventional

Funder types: Other

Identifiers

NCT02891512

2545/15

Details and patient eligibility

About

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).

Enrollment: 31 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 2 patient groups, including a placebo group

ELF and Xinepa®

Experimental group

Description:

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.

Treatment:

Other: ELF

Other: Xinepa®

ELF and Placebo Xinepa®

Placebo Comparator group

Description:

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.

Treatment:

Other: ELF

Other: Placebo Xinepa®