FINCATS

Why is this trial needed?

Carpal tunnel syndrome (CTS) is the most common peripheral nerve compression neuropathy, affecting approximately 2% of men and 5% of women in Finland and constituting a major cause of work disability.

Carpal tunnel release surgery, which divides the transverse carpal ligament to reduce pressure on the median nerve, is considered the gold standard for patients with persistent or severe symptoms. Yet, despite the widespread use of this operation, there is surprisingly little high-quality evidence supporting its efficacy.

A recent Cochrane review by our group (Lusa et al. 2024) found moderate-certainty evidence suggesting that surgery may offer only small, clinically unimportant benefits compared to nonoperative treatments. Importantly, no previous randomized controlled trial has compared carpal tunnel release with placebo surgery or no treatment.

FINCATS aims to fill this critical evidence gap.

‍

What is the primary objective of the FINCATS trial?

The aim is to evaluate the efficacy and safety of open carpal tunnel release compared to placebo surgery in patients with electrodiagnostically verified CTS who continue to experience symptoms despite at least three months of nonoperative care.

‍

What is the study design?

FINCATS is the first-ever placebo-surgery controlled randomized trial assessing the efficacy of carpal tunnel release.

Design: Prospective, randomized, placebo-surgery controlled trial with an embedded observational cohort

Participants: 180 patients with symptomatic, electrodiagnostically verified CTS

Interventions:
 • Surgical release of the transversecarpal ligament
 • Placebo surgery (identical exposurebut without ligament division)

Primary outcome: Patient Acceptable Symptom State (PASS)
 • 4 months for short-term effects
 • 12 months for longer-term effects

Secondary outcomes: Symptom severity, pain, patient-reported function, quality of life, complications, crossovers, and unblinding rates

‍

Where are we now?

We have received an approval by the Helsinki University Hospital ethics board.

Recruitment is expected to begin in fall 2025 at two Finnish hand surgery centers:

• Helsinki University Hospital (coordinating center)
• Tampere University Hospital

The protocol manuscript is under preparation and will be submitted for publication soon.

The FINCATS study builds on our team’s previous expertise in carpal tunnel syndrome research, including two Cochrane reviews on the topic, which highlighted the need for this rigorous trial.

‍

Simo Taimela - Kati Jaatinen - Saara Raatikainen - Tomasz Czuba - Leena Caravitis - Panu Nordback - Nora Suojärvi - Turkka Anttila - Jorma Ryhänen

‍