Status:
RECRUITING
A Norwegian Trial Comparing Treatment Strategies for Carpal Tunnel Syndrome
Lead Sponsor:
Diakonhjemmet Hospital
Collaborating Sponsors:
Oslo University Hospital
Vestre Viken Hospital Trust
Conditions:
Carpal Tunnel Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 treatme...
Detailed Description
CTS is the most common non-traumatic hand disorder, prevalent in approximately 4% of the adult population. The condition may have a substantial impact on an individual's quality of life, ability to ac...
Eligibility Criteria
Inclusion
- 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
- Or, in case of normal neurophysiological findings:
- Classic/probable symptoms and positive physical exam findings and/or nighttime symptoms
- Mild to moderate symptoms (intermittent, interfering with everyday life, and/or disturb sleep)
Exclusion
- 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
- Any other medical condition that according to the treating physician and/or local guidelines makes adherence to treatment protocol impossible
- Inadequate birth control1, pregnancy2, and/or breastfeeding (current at screening or planned within the duration of the study)
- Known hypersensitivity to Triamcinolone Hexacetonide (Lederspan) or any of the excipients (sorbitol, polysorbate or benzyl alcohol)
- Concomitant therapy with CYP3A-inhibitors or digitalis glycosides
- Patients vaccinated or immunized with live virus vaccines within 2 weeks of treatment
- Alcohol or other substance abuse
- Language barriers
- Other factors which make adherence to study protocol impossible
Key Trial Info
Start Date :
April 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT05306548
Start Date
April 8 2022
End Date
March 1 2028
Last Update
August 28 2025
Active Locations (5)
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1
Akershus University Hospital
Lørenskog, Akershus, Norway, 1461
2
Department of Surgery and Anesthesiology, Diakonhjemmet Hospital
Oslo, Norge, Norway, 1450
3
Department of Rheumatology, Diakonhjemmet Hospital
Oslo, Norway, 0319
4
Department of Orthopedic Surgery, Martina Hansens Hospital
Sandvika, Norway