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Finnish Carpal Tunnel Surgery Study (FINCATS)

1 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

180

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Komparator placebo: Placebo surgery
Placebo surgery: Skin incision and division of palmar aponeurosis
Procedura: Placebo surgery
Skin incision and division of the palmar aponeurosis
Inny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Patient acceptable symptom state (PASS)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Patient acceptable symptom state (PASS)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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) )
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Pillar pain - interview
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Helsinki University Central Hospital

Śledczy

  • Dyrektor Studium: Teppo LN Järvinen, Professor, Helsinki University Central Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

11 czerwca 2026

Zakończenie podstawowe (Szacowany)

30 maja 2029

Ukończenie studiów (Szacowany)

31 grudnia 2035

Daty rejestracji na studia

Pierwszy przesłany

21 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 maja 2026

Pierwszy wysłany (Rzeczywisty)

29 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

3 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • HUS/683/2025

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

All collected IPD provided that current legislation permits it.

Ramy czasowe udostępniania IPD

After publication of main results, to be specified later

Kryteria dostępu do udostępniania IPD

To be determined

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF
  • ANALITYCZNY_KOD

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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