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A Norwegian Trial Comparing Treatment Strategies for Carpal Tunnel Syndrome

NCT05306548 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2026-03-27

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER

  • Vestre Viken Hospital Trust

    collaborator OTHER

  • South-Eastern Norway Regional Health Authority

    collaborator OTHER

  • University Hospital, Akershus

    collaborator OTHER

  • Diakonhjemmet Hospital

    lead OTHER

Principal Investigators

  • Hilde B Hammer, MD, PhD · Diakonhjemmet Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-08
Primary Completion
2027-03-31
Completion
2028-03-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05306548 on ClinicalTrials.gov