A Norwegian Trial Comparing Treatment Strategies for Carpal Tunnel Syndrome

Launched by DIAKONHJEMMET HOSPITAL · Mar 23, 2022

Keywords

ClinConnect Summary

The NOR-CACTUS Trial is a study aimed at finding the best way to treat carpal tunnel syndrome (CTS), a condition that causes numbness and pain in the hand and arm. The trial will compare two different treatment approaches: one that starts with up to two injections of a steroid (given with the help of ultrasound) and then monitors the patient's progress before considering surgery, and another that begins directly with surgery. Participants will be followed for two years to see how well each treatment works, based on their own reports of symptoms and other medical assessments.

To be eligible for the study, participants must be adults (18 years or older) who have been diagnosed with mild to moderate carpal tunnel syndrome. They should have experienced symptoms that interfere with daily life or sleep, and have had a nerve test done within the last six months. However, individuals who have had previous surgery or injections for CTS in the affected hand, or those with more severe symptoms, will not be included. If you choose to participate, you can expect regular check-ups and support throughout the two years of the study, helping researchers understand which treatment option might offer better relief for patients like you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult (≥18 years of age)
• • 2. Patient history indicating CTS
• • 3. Neurophysiological examination performed within 6 months
• 4. Diagnosis of CTS based on:
• • 1. Classic/probable or possible symptoms, and neurophysiological findings consistent with CTS
• Or, in case of normal neurophysiological findings:
• • 2. Classic/probable symptoms and positive physical exam findings and/or nighttime symptoms
• • 5. Mild to moderate symptoms (intermittent, interfering with everyday life, and/or disturb sleep)
• Exclusion Criteria:
• • 1. Previous CTS surgery or corticosteroid injection in the carpal tunnel in the relevant hand
• • 2. 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.
• • 3. History suggesting underlying causes of CTS e.g. inflammatory wrist arthritis and/or flexor tenosynovitis
• • 4. Previous significant trauma or fracture, deformity or tumor in the wrist or hand in the relevant hand
• • 5. Presence of conditions affecting a normal nerve function e.g. cervical disc herniation, polyneuropathy or previous nerve injury
• • 6. 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
• • 7. Severe psychiatric or mental disorders
• • 8. Local infection or wound in the affected hand/wrist
• • 9. Any other medical condition that according to the treating physician and/or local guidelines makes adherence to treatment protocol impossible
• • 10. Inadequate birth control1, pregnancy2, and/or breastfeeding (current at screening or planned within the duration of the study)
• • 11. Known hypersensitivity to Triamcinolone Hexacetonide (Lederspan) or any of the excipients (sorbitol, polysorbate or benzyl alcohol)
• • 12. Concomitant therapy with CYP3A-inhibitors or digitalis glycosides
• • 13. Patients vaccinated or immunized with live virus vaccines within 2 weeks of treatment
• • 14. Alcohol or other substance abuse
• • 15. Language barriers
• • 16. Other factors which make adherence to study protocol impossible