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Finnish Carpal Tunnel Surgery Study (FINCATS)

maanantai 1. kesäkuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Rekrytointi

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

180

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Tutki yhteystietojen varmuuskopiointi

Opiskelupaikat

  • Suomi
      • Helsinki, Suomi
        • Rekrytointi
        • HUS group, Helsinki Central University Hospital, Meilahti Bridge Hospital
        • Ottaa yhteyttä:
        • Ottaa yhteyttä:
      • Tampere, Suomi

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kolminkertaistaa

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Carpal tunnel release
Open carpal tunnel release: skin incision, division of the palmar aponeurosis, and transverse carpal ligament.
Menettely: Carpal tunnel release
Open carpal tunnel release: skin incision, division of the palmar aponeurosis, and transverse carpal ligament.
Placebo Comparator: Placebo surgery
Placebo surgery: Skin incision and division of palmar aponeurosis
Menettely: Placebo surgery
Skin incision and division of the palmar aponeurosis
Muut: 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.
Menettely: Carpal tunnel release
Open carpal tunnel release: skin incision, division of the palmar aponeurosis, and transverse carpal ligament.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Patient acceptable symptom state (PASS)
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Patient acceptable symptom state (PASS)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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) )
Aikaikkuna: 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

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Pillar pain - interview
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Helsinki University Central Hospital

Tutkijat

  • Opintojohtaja: Teppo LN Järvinen, Professor, Helsinki University Central Hospital

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

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Torstai 11. kesäkuuta 2026

Ensisijainen valmistuminen (Arvioitu)

Keskiviikko 30. toukokuuta 2029

Opintojen valmistuminen (Arvioitu)

Maanantai 31. joulukuuta 2035

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Torstai 21. toukokuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Torstai 21. toukokuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Perjantai 29. toukokuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 3. kesäkuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 1. kesäkuuta 2026

Viimeksi vahvistettu

Maanantai 1. kesäkuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • HUS/683/2025

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

All collected IPD provided that current legislation permits it.

IPD-jaon aikakehys

After publication of main results, to be specified later

IPD-jaon käyttöoikeuskriteerit

To be determined

IPD-jakamista tukeva tietotyyppi

  • STUDY_PROTOCOL
  • MAHLA
  • ICF
  • ANALYTIC_CODE

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Ei

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