BridgeMD
NOR-CACTUS
EU CTIS ID: 2024-511223-34-00
What this study is testing
Assess if the success-rate of a treatment strategy with initial ultrasound-guided injection therapy with up to two injections, scheduled clinical assessment of treatment effect, and subsequent surgery if needed, is non-inferior to a treatment strategy where surgery is the primary treatment, evaluated 12 months after the first intervention
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult (≥18 years of age)
- Patient history indicating CTS (see section 2.2.1 in protocol)
- Neurophysiological examination performed within 6 months
- Diagnosis of CTS based on: a. Classic/probable or possible symptoms, and neurophysiological findings consistent with CTS Or, in case of normal neurophysiological findings: b. 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)
You likely can't join if
- Previous CTS surgery or corticosteroid injection in the carpal tunnel in the relevant hand
- Inadequate birth control (Only applicable for women of childbearing potential. Refer to protocol section 10.4 for definitions and contraception guidance), pregnancy (Only applicable for women of childbearing potential. Refer toprotocol section 8.3.5.), and/or breastfeeding (current at screening or planned within the duration of the study)
- Known hypersensitivity to the interventional drug (Triamcinolone Hexacetonide (Lederspan) or Triamcinolone Acetonide (Kenacort-T)), 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
See the full eligibility criteria
- Adult (≥18 years of age)
- Patient history indicating CTS (see section 2.2.1 in protocol)
- Neurophysiological examination performed within 6 months
- Diagnosis of CTS based on: a. Classic/probable or possible symptoms, and neurophysiological findings consistent with CTS Or, in case of normal neurophysiological findings: b. 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)
- Previous CTS surgery or corticosteroid injection in the carpal tunnel in the relevant hand
- Inadequate birth control (Only applicable for women of childbearing potential. Refer to protocol section 10.4 for definitions and contraception guidance), pregnancy (Only applicable for women of childbearing potential. Refer toprotocol section 8.3.5.), and/or breastfeeding (current at screening or planned within the duration of the study)
- Known hypersensitivity to the interventional drug (Triamcinolone Hexacetonide (Lederspan) or Triamcinolone Acetonide (Kenacort-T)), 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
- 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 Side 29 av 127 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.