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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ELF and Xinepa® | Experimental | 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. |
|
| ELF and Placebo Xinepa® | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincenzo Maria Saraceni | Umberto I hospital, Sapienza University of Rome | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Umberto I Hospital | Rome | 00165 | Italy |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| D010146 | Pain |
| D010292 | Paresthesia |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| 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. |
|
| 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 |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |