Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Effekt af nat- og fuldtidsskinne for karpaltunnelsyndrom (FINCROSS)

29. september 2026 opdateret af: Tampere University Hospital

Effekt af nat- og fuldtidsskinne for karpaltunnelsyndrom: et multicenter, tre-perioders, randomiseret cross-over Superiority-forsøg (FINCROSS - Finsk Crossover Trial for Carpal Tunnel Syndrome)

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.).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

110

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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.
Enhed: splinting

neutral-positioned wrist orthosis
Andet: 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.
Enhed: splinting

neutral-positioned wrist orthosis
Andet: 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.
Enhed: splinting

neutral-positioned wrist orthosis
Andet: 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.
Enhed: splinting

neutral-positioned wrist orthosis
Andet: 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.
Enhed: splinting

neutral-positioned wrist orthosis
Andet: 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.
Enhed: splinting

neutral-positioned wrist orthosis

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tampere University Hospital

Samarbejdspartnere

Mikkeli Central Hospital
Terveystalo
Hospital Nova, Central Finland

Efterforskere

  • Ledende efterforsker: Teemu Karjalainen, Tampere University Hospital
  • Ledende efterforsker: Jarkko Jokihaara, Tampere University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. februar 2023

Primær færdiggørelse (Anslået)

1. december 2028

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

18. oktober 2022

Først indsendt, der opfyldte QC-kriterier

23. november 2022

Først opslået (Faktiske)

5. december 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R22093

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner