About this trial
The aim of the study is to determine whether minimally invasive, ultrasound-guided thread carpal tunnel release leads to faster functional recovery compared to standard open and endoscopic techniques in patients with carpal tunnel syndrome.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient aged 18 years or older
Electroneurographically proven carpal tunnel syndrome
Informed Consent for trial participation
Disqualifiers
Revision surgery
Inability to give informed consent, whether it be due to an insurmountable language barrier or another reason
Trial design
Parallel
Treatments tested in this trial
TCTR (thread carpal tunnel release)
Procedure/SurgeryPercutaneous sonography guided release of carpal tunnel release
Standard-of-care
Procedure/SurgeryOpen or endoscopic carpal tunnel release based on patients' and physicians' preferences
Treatment groups
Trial outcomes
Primary outcomes
The objective functional assessment of the BCTQ score at 2 weeks
Functional assessment of the BCTQ. The BCTQ is a patient reported outcome measure (PROM) questionnaire that examines subjective symptom severity and objective overall functional status. The Functional Status Scale evaluates the ability of the patient to use their hand in daily life using 8 questions, which are scored from 1-5 with 1 as no difficulty and 5 as difficult. Therefore, the higher the score, the more difficulty the patient has with the symptom.
Secondary outcomes
The objective functional assessment of the BCTQ score
Functional assessment of the BCTQ. The BCTQ is a patient reported outcome measure (PROM) questionnaire that examines subjective symptom severity and objective overall functional status. The Functional Status Scale evaluates the ability of the patient to use their hand in daily life using 8 questions, which are scored from 1-5 with 1 as no difficulty and 5 as difficult. Therefore, the higher the score, the more difficulty the patient has with the symptom
Overall BCTQ score, which is a combination of the subjective symptom severity and the objective functional status.
The BCTQ is a patient reported outcome measure (PROM) questionnaire that examines subjective symptom severity and objective overall functional status. The Symptom Severity Scale with 11 questions is scored on a Likert scale of 1-5 and the Functional Status Scale with 8 questions is scored from 1-5 with 1 as no difficulty and 5 as difficult. Therefore, the higher the score, the more difficulty the patient has with the symptom.
The subjective symptom severity score of the BCTQ
The BCTQ is a patient reported outcome measure (PROM) questionnaire that examines subjective symptom severity and objective overall functional status. The Symptom Severity Scale describes the symptoms concerning sensibility and pain and is evaluated using 11 questions scored on a Likert scale of 1-5 with 1 as no difficulty and 5 as difficult. Therefore, the higher the score, the more difficulty the patient has with the symptom.
Hand-specific health
The Michigan Hand Questionnaire (MHQ)is one of the most widely utilized, hand-specific surveys that measures health status relevant to patients with acute and chronic hand disorders.Scale ranges from 0-100, while lower scores indicate better outcomes.
Sponsors and contacts
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