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

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome; Vitamin D Deficiency
• Intervention / Treatment: Drug: Vitamin D

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 Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Kayseri, Turkey
    • KAYSERİ CITY HOSPITAL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin D in Carpal Tunnel Syndrome	Drug: Vitamin D; Vitamin D replacement therapy was administered at 50,000 IU weekly for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
electrophysiological scale.	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	at the baseline and immediately after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
monofilament test	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.	at the baseline and immediately after treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston symptom severity scale	Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ): The questionnaire consists of two parts. "Boston Symptom Severity Scale (BSSS)", which questions the severity of symptoms, consists of 11 questions. "Boston Functional Status Scale (BFSS)", which evaluates functional capacity, consists of 8 questions. The degree of difficulty of symptoms and functional activity increases towards 5 points.	at the baseline and immediately after treatment

Collaborators and Investigators

• Sponsor: Dr. Ayşe Güç
• Collaborators: Kayseri City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Estimated): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Vitamin D Deficiency; Carpal Tunnel Syndrome; Electrophysiologia
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Nutrition Disorders; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Avitaminosis; Deficiency Diseases; Malnutrition; Syndrome; Carpal Tunnel Syndrome; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 567

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No