Comparıson Of Electromyography Results Before And After Vıtamın D Treatment In Patıents Wıth Carpal Tunnel Syndrome

Phase 4

Completed

• Conditions: Vitamin D Deficiency; Carpal Tunnel Syndrome
• Interventions: Drug: Vitamin D

• Registration Number: NCT06282640
• Lead Sponsor: Dr. Ayşe Güç

Brief Summary

Therefore, we aimed to evaluate the effectiveness of vitamin D replacement therapy on pain, electrophysiological parameters, ultrasonographic measurement results and functional status scales in CTS patients with low serum vitamin D levels.

Detailed Description

Introduction: Apart from its effect on bone health, vitamin D is also known to have beneficial effects on the neurological system. In studies, vitamin D levels were found to be low in patients with Carpal Tunnel Syndrome (CTS). However, studies examining the effects of vitamin D replacement on CTS are limited. Therefore, we aimed to evaluate the effectiveness of vitamin D replacement therapy on pain, electrophysiological parameters, ultrasonographic measurement results and functional status scales in CTS patients with low serum vitamin D levels. Materials and Methods: Our study was planned as an observational and analytical prospective. Vitamin D loading therapy was given to patients with serum vitamin D levels below 20ng/ml and mild-moderate CTS detected by electroneuromyography (ENMG). Patients with vitamin D levels above 20 ng/ml after 8 weeks were included in the study. Each patient was given a rest splint and exercise program. Patients were evaluated before and 3 months after treatment with electrophysiological, ultrasonographic, VAS, pinch-grip strength, two-point discrimination, monofilament test and Boston symptom severity scale.

Study Timeline

• Study Start: 2021-12-30
• Primary Completion: 2022-06-30
• Study Completion: 2022-08-30
• Study First Submitted: 2024-01-29
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-20
• Last Update Submitted: 2024-02-20
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

• 18-70 years old male or female gender
• Those with mild to moderate CTS according to ENMG,
• Vitamin D level <20.

Exclusion Criteria

• Severe CTS according to ENMG
• Thenar region atrophy
• diabetes mellitus,
• rheumatoid arthritis,
• hyperthyroidism,
• hypothyroidism
• Traumatic nerve injury, history of surgery
• Polyneuropathy
• Pregnancy
• Severe psychiatric illness
• Poor orientation and cooperation,
• Injection (corticosteroid, ozone, stem cell...) applied for CTS treatment within 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin D in Carpal Tunnel Syndrome	Vitamin D	-

Primary Outcome Measures

Name	Time	Method
electrophysiological scale.	at the baseline and immediately after treatment	Electrophysiological Evaluation: Neurowerk (SIGMA-Medizin-TechnicGmbH/Germany) brand ENMG device was used. Patients were evaluated at room temperature of approximately 25 °C. All measurements were made by the same doctor. Our clinic's reference values for the diagnosis of CTS are shown below

Secondary Outcome Measures

Name	Time	Method
monofilament test	at the baseline and immediately after treatment	Semmes-Weinstein monofilament test (SWMT): The first three fingertips on the palmar surface of the hand included with the 6-monofilament set of Baseline company were evaluated. Monofilament number 2.83 was taken as the threshold value for normal sensory value. SWMT was applied blindly by the same occupational therapist who was unaware of the patients' disease and the treatment they received.

Trial Locations

Locations (1)

Kayseri City Hospital; 🇹🇷 Kayseri, Turkey