A Norwegian Trial Comparing Treatment Strategies for Carpal Tunnel Syndrome (NCT05306548) | Clinical Trial Compass
Active — Not RecruitingPhase 4
A Norwegian Trial Comparing Treatment Strategies for Carpal Tunnel Syndrome
Norway258 participantsStarted 2022-04-08
Plain-language summary
Carpal tunnel syndrome (CTS) causes numbness and pain in the hand and arm, and is an important cause of work absence and disability. The aim of the NOR-CACTUS Trial is to compare outcomes of a treatment strategy where the initial treatment is up to two ultrasound-guided corticosteroid injections, followed by scheduled clinical assessment of treatment effect, and subsequent surgery if needed, to a treatment strategy where surgery is the first-line treatment. Participants will be randomized to one of the treatment strategies, and followed up for two years after start of the study intervention. Outcomes will include patient-reported, clinical, functional and neurophysiological measures, and health-economic aspects. The hypothesis of the study is that there is no difference between the two treatment groups in the percentage of patients with a satisfactory symptom relief (treatment success) one year after the initial therapeutic intervention.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult (≥18 years of age)
✓. Patient history indicating CTS
✓. Neurophysiological examination performed within 6 months
✓. Diagnosis of CTS based on:
✓. Classic/probable or possible symptoms, and neurophysiological findings consistent with CTS
✓. Mild to moderate symptoms (intermittent, interfering with everyday life, and/or disturb sleep)
Exclusion criteria
✕. Previous CTS surgery or corticosteroid injection in the carpal tunnel in the relevant hand
✕. Diagnosis of severe CTS, based on history and examination indicating severe CTS with constant symptoms including pain, loss of sensibility, dexterity or reduced temperature sensation, weakness of thumb abduction and opposition, or atrophy of thenar musculature. Disappearance of pain may indicate permanent sensory loss.
✕. History suggesting underlying causes of CTS e.g. inflammatory wrist arthritis and/or flexor tenosynovitis
✕. Previous significant trauma or fracture, deformity or tumor in the wrist or hand in the relevant hand
✕. Presence of conditions affecting a normal nerve function e.g. cervical disc herniation, polyneuropathy or previous nerve injury
✕. Major co-morbidities, such as severe malignancies, severe or uncontrolled infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class III or IV) and/or severe respiratory diseases, severe renal failure, active ulcus ventriculi, leukopenia and/or thrombocytopenia
✕. Severe psychiatric or mental disorders
✕. Local infection or wound in the affected hand/wrist