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

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ClinicalTrials.gov Identifier: NCT02891512
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
Teresa Paolucci, University of Roma La Sapienza

Brief 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).

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Other: ELF Other: Xinepa® Other: Placebo Xinepa® Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Study Start Date : July 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : January 2016


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891512


Locations
Italy
Umberto I Hospital
Rome, Italy, 00165
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Study Director: Vincenzo Maria Saraceni Umberto I hospital, Sapienza University of Rome

Responsible Party: Teresa Paolucci, Medical Director, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02891512     History of Changes
Other Study ID Numbers: 2545/15
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Teresa Paolucci, University of Roma La Sapienza:
Magnetic Fields
Pain
Paresthesia
Visual Analogue Scale

Additional relevant MeSH terms:
Nerve Compression Syndromes
Syndrome
Carpal Tunnel Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries