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

Study Overview
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Brief Summary
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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).

Official Title
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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.

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Other: ELF
* Other: Xinepa®
* Other: Placebo Xinepa®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ELF and Xinepa®<br>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<br>* 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.<br>Other: Xinepa®<br>* 2 tablets of Xinepa daily (morning and evening) for 1 month.<br>|
| Placebo Comparator: ELF and Placebo Xinepa®<br>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<br>* 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.<br>Other: Placebo Xinepa®<br>* 2 tablets of Xinepa placebo daily (morning and evening) for 1 month.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic Fields, Pain, Paresthesia, Visual Analogue Scale