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Finnish Carpal Tunnel Surgery Study (FINCATS)

1 giugno 2026 aggiornato da: Susanna Stjernberg-Salmela, Helsinki University Central Hospital

Finnish Carpal Tunnel Study - a Randomised, Placebo-surgery Controlled Trial

Carpal tunnel syndrome (CTS) is a common condition caused by pressure from a ligament on a nerve in the wrist, leading to pain, numbness, and weakness in the hand. Surgery to cut the ligament is often recommended when non-surgical treatments do not provide sufficient symptom relief, but it is unclear how much of the improvement is due to the surgery itself versus natural recovery or placebo effects.

The FINCATS study will compare standard carpal tunnel surgery with a placebo procedure in which the ligament is not cut. Participants and the healthcare staff caring for them after the procedure will not know which procedure was performed. The study's main question is whether cutting the ligament provides greater symptom relief than a placebo procedure. In addition, eligible patients who are not willing to participate in randomized setting are invited to join a parallel observational group. Participants in this observational group are treated within usual care pathway.

Participants in both the randomized and observational group will be followed for five years to assess symptom improvement, hand function, pain, quality of life, and any side effects. The goal is to provide reliable evidence to help patients and doctors make informed decisions about treatment.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

180

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Age 18-75 years
  • Clinical manifestations of carpal tunnel syndrome: paresthesia and /or hypoesthesia in the distribution of the median nerve, possibly pain
  • Electrodiagnostically (ENMG or ENEG) verified compression of the median nerve at the carpal tunnel in the wrist, performed no more than a year before recruitment.
  • Duration of symptoms 3 months or longer
  • Patient living independently
  • Patient has not responded to the use of a resting splint supporting the wrist, nor to other possible conservative forms of treatment
  • Patient able and willing to give consent
  • The patient is willing to undergo surgical treatment for carpal tunnel syndrome.
  • The patient has access to a device that can be used to complete electronic symptom questionnaires.

Exclusion Criteria:

  • Work disability
  • Clinical findings of Abductor Pollicis Brevis atrophy
  • Symptoms and Electrodiagnostic findings of some other peripheral neural entrapment than carpal tunnel syndrome
  • Rheumatoid arthritis or other forms of systemic inflammatory disease
  • Diagnosed dementia
  • Neurologic disorders affecting the function of the hand
  • Other untreated systemic disorders or diseases with poor therapeutic balance: hypertension, epilepsy, pulmonary or cardiac disease, liver or renal insufficiency, diabetes mellitus, hypothyroidism, psychiatric disease
  • Other causes of pain and paresthesia in the hand
  • Previous trauma of the hand or wrist (e.g. distal radius fracture), which has resulted in compromised hand function
  • Previous carpal tunnel release in either hand
  • Previous nerve injury to the upper limb or cervical spine

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Carpal tunnel release
Open carpal tunnel release: skin incision, division of the palmar aponeurosis, and transverse carpal ligament.
Procedura: Carpal tunnel release
Open carpal tunnel release: skin incision, division of the palmar aponeurosis, and transverse carpal ligament.
Comparatore placebo: Placebo surgery
Placebo surgery: Skin incision and division of palmar aponeurosis
Procedura: Placebo surgery
Skin incision and division of the palmar aponeurosis
Altro: Observational arm

Open carpal tunnel release: skin incision, division of the palmar aponeurosis, and division of the transverse carpal ligament.

Observational group: eligible participants included to assess potential selection bias.
Procedura: Carpal tunnel release
Open carpal tunnel release: skin incision, division of the palmar aponeurosis, and transverse carpal ligament.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient acceptable symptom state (PASS)
Lasso di tempo: 4 months

PASS is used as a binary global outcome using the following question:

"Regarding your recovery from the carpal tunnel release, specifically pertaining to paresthesia, pain and overall function of the hand, would you be content if the clinical state of your hand would remain the same as it has been the past week?" Response options are: Yes, I would be content or No, I would not be content.
4 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient acceptable symptom state (PASS)
Lasso di tempo: 6 and 9 months and 1,2,3,4 and 5 years

PASS is used as a binary global outcome measure and will be assessed using the following question:

"Regarding your recovery from the carpal tunnel release, specifically pertaining to paresthesia, pain and overall function of the hand, would you be content if the clinical state of your hand would remain the same as it has been the past week?" Response options are: Yes, I would be content or No, I would not be content.
6 and 9 months and 1,2,3,4 and 5 years
Numeric Pain Rating Scale (NRS)
Lasso di tempo: At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years
A patient-reported measure for pain intensity on an 11-point scale from 0 (no pain) to 10 (worst imaginable pain).
At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years
Health-related quality of life (EuroQol 5-Dimension 5-Level (EQ-5D-5L) index value)
Lasso di tempo: At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years
EQ-5D-5L questionnaire, Finnish language version, using the Danish value set. Score ranges from values below 0 (health states considered worse than death) to 1.00 (full health), where higher scores indicate better health-related quality of life.
At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years
Harms
Lasso di tempo: Intervention (intra-operative), at 4, 6 and 9 months and 1,2,3,4 and 5 years. In addition, unprompted contacts from participant
Harms and healthcare contacts related to the operated hand will be collected systematically and unprompted using a standardized electronic case report files (eCRF). Events will be classified by type (Adverse event, Serious Adverse Event, Suspected Unexpected Serious Adverse Reaction), attribution, timing, and nature.
Intervention (intra-operative), at 4, 6 and 9 months and 1,2,3,4 and 5 years. In addition, unprompted contacts from participant
Global Impression of Improvement (PGI-I)
Lasso di tempo: 4, 6 and 9 months and 1,2,3,4 and 5 years
A single-item patient-reported measure indicating overall perceived improvement since the start of treatment, rated on a 7-point scale from 1 (very much improved) to 7 (very much worse).
4, 6 and 9 months and 1,2,3,4 and 5 years
6-Item carpal tunnel syndrome (CTS) symptoms scale
Lasso di tempo: At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years
The CTS-6 is a validated six-item patient-reported questionnaire used to assess the severity of carpal tunnel syndrome symptoms, including pain, numbness or tingling, and functional impairment, with scores ranging from 0 (least severe) and 26 (most severe). A score >12 correlates with an 80% probability of CTS.
At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years
Patient-Specific Functional Scale (PSFS)
Lasso di tempo: At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years
The Patient-Specific Functional Scale (PSFS) is a patient-reported measure that assesses level of functional limitations in 3-5 activities identified as important by the patient and deemed difficult to perform by the patient, due to the hand condition. The PSFS is rated on an ordinal scale from 0 (unable to perform the activity) to 10 (able to perform the activity at the same level as before the disease.)
At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years
Health-related quality of life: EuroQol 5-Dimensions (EQ-5D) Visual Analogue Scale (VAS) (EQ VAS) )
Lasso di tempo: At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years
EQ-5D is a generic patient rated outcome measure (PROM) comprising five health dimensions (mobility, self-care, daily activities, pain/discomfort, anxiety/depression) and a VAS. EQVAS is a vertical visual analogue scale, on which patients rate their general health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Pillar pain - interview
Lasso di tempo: At recruitment and 1 and 4 months after intervention.

Pillar pain will be assessed using two questions:

  1. Do you have pain at rest in the palm of your hand?
  2. Are you able to bear weight on your extended wrist and hand? Response options: Yes or No.
At recruitment and 1 and 4 months after intervention.
Pillar pain - pressure pain thresholds
Lasso di tempo: At recruitment and 1 and 4 months after intervention.
Pillar pain will be assessed through pressure pain thresholds on thenar and hypothenar eminences with a digital algometer
At recruitment and 1 and 4 months after intervention.
Pillar pain - palmar skin sensation
Lasso di tempo: At recruitment and 1 and 4 months after intervention.
Palmar skin sensation will be assessed at thenar and hypothenar eminences with a standard evaluation tool neuropen.
At recruitment and 1 and 4 months after intervention.
Blinding fidelity
Lasso di tempo: At 4 months after intervention.
Blinding fidelity will be assessed by asking participants which treatment group they believe they were allocated to. Response options will include "Carpal tunnel release," "Placebo intervention," or "Unsure."
At 4 months after intervention.
Conduction velocity
Lasso di tempo: At 4 months after intervention.
Nerve conduction velocities will be assessed in randomized participants using standard electroneurography techniques. Measurements will quantify median nerve function across the carpal tunnel to evaluate changes after intervention.
At 4 months after intervention.
Medication
Lasso di tempo: At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years
Need for medication due to pain. Response options: Every day, On most days of the week, 1-2 times a week, Rarely 5. Never
At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years
Clinical examination
Lasso di tempo: At recruitment; at 4, and 12 months; and at 5 years after primary surgery.
Standard hand surgical clinical examination and provocation tests: Tinell, Tethro, Phalen and atrophy evaluation
At recruitment; at 4, and 12 months; and at 5 years after primary surgery.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Helsinki University Central Hospital

Investigatori

  • Direttore dello studio: Teppo LN Järvinen, Professor, Helsinki University Central Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

11 giugno 2026

Completamento primario (Stimato)

30 maggio 2029

Completamento dello studio (Stimato)

31 dicembre 2035

Date di iscrizione allo studio

Primo inviato

21 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 maggio 2026

Primo Inserito (Effettivo)

29 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • HUS/683/2025

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

All collected IPD provided that current legislation permits it.

Periodo di condivisione IPD

After publication of main results, to be specified later

Criteri di accesso alla condivisione IPD

To be determined

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • CODICE_ANALITICO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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