Comparing treatment strategies for carpal tunnel syndrome
The NOR-CACTUS Trial - A Norwegian Trial Comparing Treatment Strategies for Carpal Tunnel Syndrome
This study is testing whether starting treatment for carpal tunnel syndrome with ultrasound-guided steroid injections followed by surgery if needed is better than going straight to surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 258 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Diakonhjemmet Hospital Academic / other |
| Locations | 5 sites (Oslo, Norge and 4 other locations) |
| Trial ID | NCT05306548 on ClinicalTrials.gov |
What this trial studies
This trial aims to compare two treatment strategies for carpal tunnel syndrome (CTS): one that starts with up to two ultrasound-guided corticosteroid injections followed by surgery if needed, and another that begins with surgery as the first-line treatment. Participants will be randomly assigned to one of these strategies and monitored for two years to evaluate outcomes such as symptom relief, functional improvement, and healthcare costs. The study seeks to determine if there is a significant difference in treatment success between the two approaches, addressing the balance between non-surgical and surgical interventions for CTS.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with mild to moderate symptoms of carpal tunnel syndrome.
Not a fit: Patients with severe carpal tunnel syndrome or those who have previously undergone surgery or corticosteroid injections for the condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and less invasive treatment options for patients with carpal tunnel syndrome.
How similar studies have performed: While there is limited direct comparison of corticosteroid injections versus surgery for CTS, the approach of evaluating non-surgical treatments first is gaining interest and has shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oslo, Norge and 4 other locations
- Department of Surgery and Anesthesiology, Diakonhjemmet Hospital — Oslo, Norge, Norway (Recruiting)
- Akershus University Hospital — Lørenskog, Viken, Norway (Recruiting)
- Department of Rheumatology, Diakonhjemmet Hospital — Oslo, Norway (Active_not_recruiting)
- Department of Orthopedic Surgery, Martina Hansens Hospital — Sandvika, Norway (Recruiting)
- Department of Rheumatology, Martina Hansens Hospital — Sandvika, Norway (Recruiting)
Study contacts
- Principal investigator: Hilde B Hammer, MD, PhD — Diakonhjemmet Hospital
- Study coordinator: Ulf G Sundin, MD, PhD
- Email: uffe.sundin@gmail.com
- Phone: +4740614198
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.