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

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.

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).

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Other: ELF; Other: Xinepa®; Other: Placebo Xinepa®

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00165
    • Umberto I Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; Other: Xinepa®; 2 tablets of Xinepa daily (morning and evening) for 1 month.
Placebo Comparator: 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.	Other: 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.; Other: Placebo Xinepa®; 2 tablets of Xinepa placebo daily (morning and evening) for 1 month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Visual Analogue Scale (VAS) from baseline to 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.	baseline, 4 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Semmes-Weinstein Monofilaments of light touch and pressure sensation test from baseline to 12 weeks	Involves the use of five monofilaments of different colours that identify the levels of decrease in sensitivity, measurable, necessary for the evaluation of the perception of the surface touch.	baseline, 4 weeks, 12 weeks
Change of Boston Carpal Tunnel Questionnaire from baseline to 12 weeks	It consists of two scales, the scale of the severity of symptoms (SSS) and functional status scale (FSS). The first includes the first 11 questions relating to: the intensity of pain during the day and night, lasting pain during the day, sleep, weakness, tingling sensation during the night and its frequency and abilities. Each question provides a metric scale ranging from 1 (absence of symptoms) to 5 (severe symptoms). The second scale includes the last eight questions concerning activities such as writing, buttoning clothes, hold a book while reading, hold up the phone, clean, carry bags, open the lid of a jar.	baseline, 4 weeks, 12 weeks
Change of the measurement of the grip strength trough the Jamar dynamometer from baseline to 12 weeks	It consists of a manometer with a double scale to recorder static force in kilos and pounds and a handle with 5 different positions of increasing amplitude from 3.5 cm to 8.8 cm. The patient holds the dynamometer and performs a grip at maximum force. The final score originates from the average of three measurements taken for each position of the handle.	baseline, 4 weeks, 12 weeks
Change of the measurement of the pinch strength trough the Pinch Gauges dynamometer from baseline to 12 weeks	It consists of a manometer with a double scale to recorder static force in kilos and libbre and two caliper levers with the tips away from each other of 2.2 cm/ 1.9 cm. Three types of pliers are evaluated: side, three tips, tip against tip. The patient holds the dynamometer and performs a grip at maximum force. The final score originates from the average of three measurements taken for each type of tongs.	baseline, 4 weeks, 12 weeks
Change of electroneurography from baseline to 12 months	It allows the study of nerve of the median nerve (speed of motor-sentitive run and latency).	baseline, 4 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Investigators: Study Director: Vincenzo Maria Saraceni, Umberto I Hospital, Sapienza University of Rome

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: August 31, 2016
• First Submitted That Met QC Criteria: August 31, 2016
• First Posted (Estimate): September 7, 2016

Study Record Updates

• Last Update Posted (Estimate): November 22, 2016
• Last Update Submitted That Met QC Criteria: November 21, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Pain; Visual Analogue Scale; Paresthesia; Magnetic Fields
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: 2545/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED