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Effekt av natt- og heltidsskinne for karpaltunnelsyndrom (FINCROSS)

29. september 2026 oppdatert av: Tampere University Hospital

Effekt av natt- og heltidsskinne for karpaltunnelsyndrom: en multisenter, tre-perioders, randomisert cross-over-overlegenhetsforsøk (FINCROSS – finsk crossover-prøve for karpaltunnelsyndrom)

Carpal tunnel syndrome is a common compression neuropathy of upper extremities. Its usual symptoms are pain, numbness and tingling of fingers, which tend to be worse at night. Splinting the wrist with an external orthosis is usually a first-line treatment provided to most people with mild to moderate disease.

The FINCROSS trial (randomized cross-over trial) aims to assess the effect of night-time and full-time splinting in comparison with no-treatment. It also aims to identify possible subgroups of people who would benefit from splinting, as well as assess if positive response to splinting is associated with subsequent lower need of surgery.

The trial will recruit 110 people with carpal tunnel syndrome in Finland. Each participant will undergo all three treatment periods in a randomised order: 1) splinting at night-time for six weeks, 2) splinting both day and night for six weeks; and 3) be assessed under a six weeks long control period of no-treatment.

Each treatment period will be separated with a three-week washout period. Therefore, the whole treatment sequence for each participant lasts 24 weeks after randomization. The participant will be followed-up to 1 year after the randomisation.

Additionally, the participants will get instructions for self-administered stretching exercises to perform throughout the study. All participants will be asked to avoid any intervention administered or supervised by medical personnel (such as structured supervised exercises, manual therapy, steroid injections, surgery, etc.).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

110

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

  • Finland
      • Helsinki, Finland
        • Rekruttering
        • Terveystalo Kamppi
        • Ta kontakt med:
          • Teemu Paatela
      • Jyväskylä, Finland
        • Rekruttering
        • Hospital Nova of Central Finland
        • Ta kontakt med:
          • Teemu Karjalainen
      • Jyväskylä, Finland
        • Rekruttering
        • Terveystalo Jyväskylä
        • Ta kontakt med:
          • Teemu Karjalainen
      • Mikkeli, Finland
        • Rekruttering
        • Mikkeli Central Hospital
        • Ta kontakt med:
          • Anniina Laurema
      • Tampere, Finland
        • Aktiv, ikke rekrutterende
        • Tampere University Hospital
      • Tampere, Finland
        • Rekruttering
        • Terveystalo Tampere
        • Ta kontakt med:
          • Teemu Karjalainen

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Clinically confirmed carpal tunnel syndrome (CTS) of any severity level (diagnostic criteria: numbness, pain or paraesthesia in the median nerve distribution area of wrist and fingers),
  2. Symptom duration of CTS for at least 3 weeks,
  3. No previous corticosteroid injection for CTS during last 6 months,
  4. No previous surgery for CTS,
  5. Aged 18 years or older,
  6. Able to complete self-report questionnaires electronically,
  7. Able to understand Finnish,
  8. Willing to join the study and follow the study protocol instructions,
  9. Sign informed consent.

Exclusion Criteria:

  1. Nerve root or plexus disorders that might be causing CTS mimicking symptoms (e.g., cervical radiculopathy, thoracic outlet syndrome, or whiplash associated disorders),
  2. Other neurological condition affecting the function of the hand such as Multiple Sclerosis, previous nerve injury,
  3. Active Rheumatoid arthritis or any other active inflammatory joint disease affecting the hand,
  4. Thenar muscle atrophy,
  5. Untreated hypothyroidism,
  6. Known allergy to any of the splint materials (self-reported by patient),
  7. Long term treatment (over 4 months) for CTS with no response,
  8. Any other known reason that could prevent from participation for the study time.

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: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Sequence of three treatment periods in the following order: ABC

Splinting at night while sleeping for 6 weeks (period A), then no treatment for 6 weeks (period B), then splinting at day and night for 6 weeks (period C). Each treatment period will be separated by 3-week washout period.
Enhet: splinting

neutral-positioned wrist orthosis
Annen: Sequence of three treatment periods in the following order: ACB

Splinting at night while sleeping for 6 weeks (period A), then splinting at day and night for 6 weeks (period C), then no treatment for 6 weeks (period B). Each treatment period will be separated by 3-week washout period.
Enhet: splinting

neutral-positioned wrist orthosis
Annen: Sequence of three treatment periods in the following order: BAC

No treatment for 6 weeks (period B), then splinting at night while sleeping for 6 weeks (period A), then splinting at day and night for 6 weeks (period C). Each treatment period will be separated by 3-week washout period.
Enhet: splinting

neutral-positioned wrist orthosis
Annen: Sequence of three treatment periods in the following order: BCA

No treatment for 6 weeks (period B), then splinting at day and night for 6 weeks (period C), then splinting at night while sleeping for 6 weeks (period A). Each treatment period will be separated by 3-week washout period.
Enhet: splinting

neutral-positioned wrist orthosis
Annen: Sequence of three treatment periods in the following order: CAB

Splinting at day and night for 6 weeks (period C), then splinting at night while sleeping for 6 weeks (period A), then no treatment for 6 weeks (period B). Each treatment period will be separated by 3-week washout period.
Enhet: splinting

neutral-positioned wrist orthosis
Annen: Sequence of three interventions/treatments in the following order: CBA

Splinting at day and night for 6 weeks (period C), then no treatment for 6 weeks (period B), then splinting at night while sleeping for 6 weeks (period A). Each treatment period will be separated by 3-week washout period.
Enhet: splinting

neutral-positioned wrist orthosis

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change of The 6-item CTS Symptoms Scale scores between baseline and 6 weeks
Tidsramme: 6 weeks, i.e. end of each treatment period

6-item CTS Symptoms Scale is a 6-item questionnaire, with score from 1 to 5 to each of the item, higher score indicating worse symptoms. The study will use a Finnish version of The 6-item CTS Symptoms Scale.
6 weeks, i.e. end of each treatment period

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change of The 6-item CTS Symptoms Scale scores between baseline and 3 weeks
Tidsramme: 3 weeks, i.e. middle of each treatment period

6-item CTS Symptoms Scale is a 6-item questionnaire, with score from 1 to 5 to each of the item, higher score indicating worse symptoms. The study will use a Finnish version of The 6-item CTS Symptoms Scale.
3 weeks, i.e. middle of each treatment period
Change of The 6-item CTS Symptoms Scale scores between baseline and 1 year
Tidsramme: 1 year

6-item CTS Symptoms Scale is a 6-item questionnaire, with score from 1 to 5 to each of the item, higher score indicating worse symptoms. The study will use a Finnish version of The 6-item CTS Symptoms Scale.
1 year
Change of The Boston Carpal Tunnel Questionnaire Symptom Severity Scale scores (BCTQ SSS) between baseline and 6 weeks of each treatment period
Tidsramme: 6 weeks, i.e. end of each treatment period

BCTQ SSS is an 11-item questionnaire, with score from 1 to 5 to each of the item, higher score indicating worse symptoms. The study will use a Finnish version of the BCTQ SSS.
6 weeks, i.e. end of each treatment period
Change of The Boston Carpal Tunnel Questionnaire Symptom Severity Scale scores (BCTQ SSS) between baseline and 1 year
Tidsramme: 1 year

BCTQ SSS is an 11-item questionnaire, with score from 1 to 5 to each of the item, higher score indicating worse symptoms. The study will use a Finnish version of the BCTQ SSS.
1 year
Change of The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS) between baseline and 6 weeks of each treatment period
Tidsramme: 6 weeks, i.e. end of each treatment period

BCTQ FSS is an 8-item questionnaire, with score from 1 to 5 to each of the item, higher score indicating worse function. The study will use a Finnish version of the BCTQ FSS.
6 weeks, i.e. end of each treatment period
Change of The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS) between baseline and 1 year
Tidsramme: 1 year

BCTQ FSS is an 8-item questionnaire, with score from 1 to 5 to each of the item, higher score indicating worse function. The study will use a Finnish version of the BCTQ FSS.
1 year
Change of The Boston Carpal Tunnel Questionnaire (BCTQ) Total between baseline and 6 weeks
Tidsramme: 6 weeks, i.e. end of each treatment period

BCTQ Total consists of BCTQ SSS and BCTQ FSS, with score from 1 to 5 to each of the item, higher score indicating worse function.
6 weeks, i.e. end of each treatment period
Change of The Boston Carpal Tunnel Questionnaire (BCTQ) Total between baseline and 1 year
Tidsramme: 1 year

BCTQ Total consists of BCTQ SSS and BCTQ FSS, with score from 1 to 5 to each of the item, higher score indicating worse function.
1 year
Overall improvement as measured by 7-point Likert Scale
Tidsramme: 6 weeks, i.e. end of each treatment period

7-point Likert Scale assesses the improvement of hand symptoms with 7 possible scores: much better, better, somewhat better, no changes, somewhat worse, worse, much worse.
6 weeks, i.e. end of each treatment period
Overall improvement as measured by 7-point Likert Scale
Tidsramme: 1 year

7-point Likert Scale assesses the improvement of hand symptoms with 7 possible scores: much better, better, somewhat better, no changes, somewhat worse, worse, much worse.
1 year
Change of The EuroQol 5-dimension (EQ-5D-5L) Health Status and Quality-of-life Measure score between baseline and 6 weeks of each treatment period
Tidsramme: 6 weeks, i.e. end of each treatment period

Finnish version of EQ-5D-5L will be used.
6 weeks, i.e. end of each treatment period
Change of The EuroQol 5-dimension (EQ-5D-5L) Health Status and Quality-of-life Measure score between baseline and 1 year
Tidsramme: 1 year

Finnish version of EQ-5D-5L will be used.
1 year
Adverse effects
Tidsramme: up to 1 year

Assessed by participant self-reported adverse events.
up to 1 year
Need for surgery
Tidsramme: up to 1 year

Assessed by participant self-reported information of referral to or executed surgery.
up to 1 year
Escape treatments (e.g., corticosteroid injection or any other treatment supervised by medical personnel)
Tidsramme: up to 1 year

Assessed by participant self-reported information of undergoing or having undergone the escape treatment.
up to 1 year

Samarbeidspartnere og etterforskere

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

Sponsor

Tampere University Hospital

Samarbeidspartnere

Mikkeli Central Hospital
Terveystalo
Hospital Nova, Central Finland

Etterforskere

  • Hovedetterforsker: Teemu Karjalainen, Tampere University Hospital
  • Hovedetterforsker: Jarkko Jokihaara, Tampere University 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 (Faktiske)

15. februar 2023

Primær fullføring (Antatt)

1. desember 2028

Studiet fullført (Antatt)

1. desember 2028

Datoer for studieregistrering

Først innsendt

18. oktober 2022

Først innsendt som oppfylte QC-kriteriene

23. november 2022

Først lagt ut (Faktiske)

5. desember 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • R22093

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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