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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06282640
• Other study ID #: 567
• Status: Completed
• Phase: Phase 4
• Start date: December 30, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: February 2024
• Source: Kayseri Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: August 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome
• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D
Vitamin D replacement therapy was administered at 50,000 IU weekly for 8 weeks.

Locations

Country	Name	City	State
Turkey	Kayseri City Hospital	Kayseri

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Ayse Güç	Kayseri City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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