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Finnish Carpal Tunnel Surgery Study (FINCATS)

1. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

180

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Carpal tunnel release
Open carpal tunnel release: skin incision, division of the palmar aponeurosis, and transverse carpal ligament.
Fremgangsmåte: Carpal tunnel release
Open carpal tunnel release: skin incision, division of the palmar aponeurosis, and transverse carpal ligament.
Placebo komparator: Placebo surgery
Placebo surgery: Skin incision and division of palmar aponeurosis
Fremgangsmåte: Placebo surgery
Skin incision and division of the palmar aponeurosis
Annen: 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.
Fremgangsmåte: Carpal tunnel release
Open carpal tunnel release: skin incision, division of the palmar aponeurosis, and transverse carpal ligament.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient acceptable symptom state (PASS)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient acceptable symptom state (PASS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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) )
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pillar pain - interview
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Helsinki University Central Hospital

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

11. juni 2026

Primær fullføring (Antatt)

30. mai 2029

Studiet fullført (Antatt)

31. desember 2035

Datoer for studieregistrering

Først innsendt

21. mai 2026

Først innsendt som oppfylte QC-kriteriene

21. mai 2026

Først lagt ut (Faktiske)

29. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HUS/683/2025

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

All collected IPD provided that current legislation permits it.

IPD-delingstidsramme

After publication of main results, to be specified later

Tilgangskriterier for IPD-deling

To be determined

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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