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Completed

NCT Number: NCT06282640

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.

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Key information

Conditions

Carpal Tunnel Syndrome Avitaminosis Cumulative Trauma Disorders Deficiency Diseases Malnutrition Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Nutrition Disorders Nutritional and Metabolic Diseases Peripheral Nervous System Diseases Sprains and Strains Vitamin D Deficiency Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kayseri City Hospital

Kayseri, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Drug

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

Primary outcomes

  1. electrophysiological scale.

    Time frame: 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 outcomes

  1. monofilament test

    Time frame: 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.

Other outcomes

  1. Boston symptom severity scale

    Time frame: at the baseline and immediately after treatment

    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.

Sponsors and collaborators

Lead sponsor

Dr. Ayşe Güç

Other Gov

Collaborators

  • Kayseri City Hospital

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 28, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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