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Completed

NCT Number: NCT02891512

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

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).

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Paresthesia Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Sensation Disorders Signs and Symptoms Somatosensory Disorders Sprains and Strains Wounds and Injuries

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umberto I Hospital

Rome, 00165, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ELF

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®

Other

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

Placebo Xinepa®

Other

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

Primary outcomes

  1. 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

  1. Change of Semmes-Weinstein Monofilaments of light touch and pressure sensation test from baseline to 12 weeks

    Time frame: baseline, 4 weeks, 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.

  2. Change of Boston Carpal Tunnel Questionnaire from baseline to 12 weeks

    Time frame: baseline, 4 weeks, 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.

  3. Change of the measurement of the grip strength trough the Jamar dynamometer from baseline to 12 weeks

    Time frame: baseline, 4 weeks, 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.

  4. Change of the measurement of the pinch strength trough the Pinch Gauges dynamometer from baseline to 12 weeks

    Time frame: baseline, 4 weeks, 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.

  5. Change of electroneurography from baseline to 12 months

    Time frame: baseline, 4 weeks, 12 weeks

    It allows the study of nerve of the median nerve (speed of motor-sentitive run and latency).

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Sep 7, 2016
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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