Very Low Frequency Magnetic Fields Versus the Supplement "Xinepa" in the Treatment of the Carpal Tunnel Syndrome
- Conditions
- Carpal Tunnel Syndrome
- Interventions
- Other: ELFOther: Placebo Xinepa®Other: Xinepa®
- Registration Number
- NCT02891512
- Lead Sponsor
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- Diagnosis of carpal tunnel syndrome
- Pregnancy;
- Pacemaker or other metallic implants;
- Systemic infectious disorders;
- Neoplastic disorders;
- Epilepsy;
- Severe heart disease.
- Known hypersensitivity to the components of Xinepa
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ELF and Placebo Xinepa® 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. ELF and Xinepa® ELF 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 Xinepa® 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. ELF and Placebo Xinepa® ELF 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.
- Primary Outcome Measures
Name Time Method Change of Visual Analogue Scale (VAS) from baseline to 12 weeks 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
Name Time Method Change of Boston Carpal Tunnel Questionnaire from baseline to 12 weeks 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.
Change of the measurement of the grip strength trough the Jamar dynamometer from baseline to 12 weeks 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.
Change of Semmes-Weinstein Monofilaments of light touch and pressure sensation test from baseline to 12 weeks 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.
Change of the measurement of the pinch strength trough the Pinch Gauges dynamometer from baseline to 12 weeks 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.
Change of electroneurography from baseline to 12 months baseline, 4 weeks, 12 weeks It allows the study of nerve of the median nerve (speed of motor-sentitive run and latency).
Trial Locations
- Locations (1)
Umberto I Hospital
🇮🇹Rome, Italy