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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Norway
Akershus University Hospital
RECRUITING
Lørenskog
Department of Rheumatology, Diakonhjemmet Hospital
ACTIVE_NOT_RECRUITING
Oslo
Department of Surgery and Anesthesiology, Diakonhjemmet Hospital
RECRUITING
Oslo
Department of Orthopedic Surgery, Martina Hansens Hospital
RECRUITING
Sandvika
Department of Rheumatology, Martina Hansens Hospital
RECRUITING
Sandvika
Contact Information
Primary
Ulf G Sundin, MD, PhD
uffe.sundin@gmail.com
+4740614198
Backup
Siri Lillegraven, MD, MPH, PhD
siri.lillegraven@gmail.com
Time Frame
Start Date: 2022-04-08
Estimated Completion Date: 2028-03
Participants
Target number of participants: 258
Treatments
Active_comparator: Surgery treatment strategy
Primary open surgical carpal tunnel release. Treatment effect is monitored on scheduled follow-up visits. Re-operation may be performed if medically indicated (e.g. postoperative complication, or failure of the primary procedure)
Experimental: Injection treatment strategy
Primary treatment with ultrasound-guided corticosteroid injection. Treatment effect is monitored on scheduled follow-up visits. One additional injection may be administered, and subsequently surgical carpal tunnel release is performed in case of unsatisfactory treatment effect of the injection therapy. Treatment effect is graded on a 5-leve scale by subject from 1 (complete improvement) to 5 (severe worsening) of symptoms. Incomplete improvement (score 2 or higher) results in a second injection or secondary surgery.
Sponsors
Collaborators: Martina Hansen's Hospital, Oslo University Hospital, University Hospital, Akershus, South-Eastern Norway Regional Health Authority
Leads: Diakonhjemmet Hospital

This content was sourced from clinicaltrials.gov