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ACTIVE NOT RECRUITING

NCT05306548

PHASE4

A Norwegian Trial Comparing Treatment Strategies for Carpal Tunnel Syndrome

Sponsor: Diakonhjemmet Hospital

View on ClinicalTrials.gov

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.

Official title: The NOR-CACTUS Trial - A Norwegian Trial Comparing Treatment Strategies for Carpal Tunnel Syndrome

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

258

Start Date

2022-04-08

Completion Date

2028-03

Last Updated

2026-03-27

Healthy Volunteers

Conditions

Carpal Tunnel Syndrome

Interventions

PROCEDURE

Surgical carpal tunnel release

Open surgical division of the flexor retinaculum of the palm/wrist to release pressure on the median nerve

DRUG

Injection, Triamcinolone Hexacetonide, Per 5 Mg

Ultrasound-guided injection of 20 mg of triamcinolone hexacetonide (or -acetonide) into the carpal tunnel space close to the median nerve

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

Locations (5)

Akershus University Hospital

Lørenskog, Akershus, Norway

Department of Surgery and Anesthesiology, Diakonhjemmet Hospital

Oslo, Norge, Norway

Department of Rheumatology, Diakonhjemmet Hospital

Oslo, Norway

Department of Orthopedic Surgery, Martina Hansens Hospital

Sandvika, Norway

Department of Rheumatology, Martina Hansens Hospital