Clinical trial NCT06658886: Comparison of the Efficacy of Ultrasound-Guided Corticosteroid Injection and Paraffin Therapy in Carpal Tunnel Syndrome
Official title: Comparison of the Efficacy of Ultrasound-Guided Corticosteroid Injection and Paraffin Therapy in Carpal Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Beylikduzu State Hospital
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Mild and moderate carpal tunnel syndrome

Brief summary: The aim of this study is to compare the efficacy of paraffin therapy, a physical therapy modality, and ultrasound-guided corticosteroid injection in the treatment of carpal tunnel syndrome, the most common entrapment neuropathy. By doing so, the study will evaluate the effectiveness and feasibility of these two alternative, low-side-effect treatments for managing this frequently encountered condition.

Detailed description: A total of 46 patients, aged 18-65, diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological studies, will be included in the study.Pain levels will be assessed using the Visual Analog Scale (VAS), and functional impairment will be measured with the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ). Electrophysiological evaluations will be performed by a neurology specialist at the 1st and 3rd month follow-ups outside of working hours and without being billed to the Social Security Institution (SGK). VAS, BCTQ scores, and electrophysiological parameters will be evaluated at baseline, and at the 4th and 12th-week follow-ups post-treatment. Electrophysiological measurements will include median nerve distal motor latency (MMNDL), median nerve distal sensory latency (MNSDL), sensory nerve conduction velocity (SNCV), compound muscle action potential (CMAP), and sensory nerve action potential (SNAP) amplitudes.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-65.
* Diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological studies.
* Received either ultrasound-guided corticosteroid injection or paraffin therapy.
* Symptoms persisting for at least 3 months.

Exclusion Criteria:

* Diagnosis of other conditions causing neuropathic symptoms (e.g., polyneuropathy, brachial plexopathy, thoracic outlet syndrome).
* History of previous injection or surgery for carpal tunnel syndrome.

Primary outcomes:
measure: Visual Analog Scale (VAS):
timeFrame: 0 day, 4th week and 12th week
measure: Boston Carpal Tunnel Syndrome Questionnaire Symptom Severity Scale (BCTQ-SSS)
timeFrame: 0 day, 4th week and 12th week
measure: Boston Carpal Tunnel Syndrome Questionnaire Functional Status Scale (BCTQ-FSS)
timeFrame: 0 day, 4th week and 12th week
Secondary outcomes:
measure: Median nerve distal motor latency
timeFrame: 0 day, 4th week and 12th week
measure: Median nerve distal sensory latency
timeFrame: 0 day, 4th week and 12th week
measure: Sensory nerve conduction velocity
timeFrame: 0 day, 4th week and 12th week
measure: Motor nerve conduction velocity
timeFrame: 0 day, 4th week and 12th week
measure: Sensory nerve action potential amplitude
timeFrame: 0 day, 4th week and 12th week
measure: Motor nerve action potential amplitude
timeFrame: 0 day, 4th week and 12th week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Beylikdüzü State Hospital
state: Beylikdüzü
Study officials:
References: