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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02891512
• Other study ID #: 2545/15
• Status: Completed
• Phase: N/A
• First received: August 31, 2016
• Last updated: November 21, 2016
• Start date: July 2015
• Est. completion date: January 2016

Study information

• Verified date: November 2016
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Italy	Umberto I Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes