Beylikdüzü State Hospital
Istanbul, Beylikdüzü, 34147, Turkey (Türkiye)
Location status: Recruiting
Recruiting
NCT Number: NCT06658886
Comparison of the Efficacy of Ultrasound-Guided Corticosteroid Injection and Paraffin Therapy in Carpal Tunnel Syndrome
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
No intervention
OtherNo intervention
Primary outcomes
-
Visual Analog Scale (VAS):
Time frame: 0 day, 4th week and 12th week
The VAS will be used to measure pain intensity. Patients will mark their pain level on a 10 cm scale, where 0 represents "no pain" and 10 represents the "worst imaginable pain." This will be evaluated at baseline, and at the 4th and 12th weeks post-treatment.
-
Boston Carpal Tunnel Syndrome Questionnaire Symptom Severity Scale (BCTQ-SSS)
Time frame: 0 day, 4th week and 12th week
The SSS assesses the severity of carpal tunnel symptoms such as pain, tingling, and numbness. The total score for this scale ranges from a minimum of 11 to a maximum of 55. A lower score indicates mild or no symptoms, while a higher score suggests more severe symptoms. As the score increases, the severity of symptoms worsens, with a score closer to 55 reflecting a significantly greater impact on daily life.
-
Boston Carpal Tunnel Syndrome Questionnaire Functional Status Scale (BCTQ-FSS)
Time frame: 0 day, 4th week and 12th week
The SSS assesses the severity of carpal tunnel symptoms such as pain, tingling, and numbness. The total score for this scale ranges from a minimum of 11 to a maximum of 55. A lower score indicates mild or no symptoms, while a higher score suggests more severe symptoms. As the score increases, the severity of symptoms worsens, with a score closer to 55 reflecting a significantly greater impact on daily life.
Secondary outcomes
-
Median nerve distal motor latency
Time frame: 0 day, 4th week and 12th week
It is a finding from electrophysiological evaluation
-
Median nerve distal sensory latency
Time frame: 0 day, 4th week and 12th week
It is a finding from electrophysiological evaluation
-
Sensory nerve conduction velocity
Time frame: 0 day, 4th week and 12th week
It is a finding from electrophysiological evaluation
-
Motor nerve conduction velocity
Time frame: 0 day, 4th week and 12th week
It is a finding from electrophysiological evaluation
-
Sensory nerve action potential amplitude
Time frame: 0 day, 4th week and 12th week
It is a finding from electrophysiological evaluation
-
Motor nerve action potential amplitude
Time frame: 0 day, 4th week and 12th week
It is a finding from electrophysiological evaluation
Study contacts
Contact information is provided by the study sponsor or research team.
Büşra Şirin Ahısha
CONTACT
Büşra Şirin Ahısha, MD
CONTACT
Sponsors and collaborators
Lead sponsor
Beylikduzu State Hospital
Other
Registry information
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Oct 26, 2024
- Registry last updated
- Dec 12, 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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