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Sonographic Evaluation of Patients With Carpal Tunnel Syndrome Following Steroid Injection

24. april 2017 opdateret af: Taipei Veterans General Hospital, Taiwan
The objective of this study was to assess sonographic changes of the median nerve after steroid injection for carpal tunnel syndrome.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Patients with CTS were recruited. The Boston Questionnaire (BQ) was administered and ultrasonographic and electrophysiological examinations were performed before and at two, six, and 12 weeks after steroid injection. Cross sectional area (CSA) was measured at 2 levels: at the tunnel inlet and in the mid-carpal tunnel. Flattening ratio (FR) was measured only in the mid-carpal tunnel. Correlation analyses between baseline ultrasonography, BQ, and electrophysiological measures were performed.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

54

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Taiwan
      • Taipei, Taiwan
        • Rekruttering
        • Teipei Veterans General Hospital
        • Kontakt:
          • Jia chi Wang, MD
          • Telefonnummer: 886-2-28757361

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 til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. clinical diagnosis of CTS
  2. The diagnosis of CTS was confirmed by electrophysiological tests.

Exclusion Criteria:

  1. neurologic disorders that could mimic CTS such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome
  2. history of distal radius fracture
  3. pregnancy or lactation
  4. regular use of systemic NSAIDs or corticosteroids
  5. known allergy to corticosteroids and local anesthetics.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: steroid injection
ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide
Medicin: steroid injection
ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide
Andre navne:
  • triamcinolonacetonid

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cross sectional area
Tidsramme: 12 weeks
The CSA of the median nerve was measured at 2 levels: at the carpal tunnel inlet (CSA-I; immediately prior to the proximal margin of the flexor retinaculum) and in the mid-carpal tunnel (CSA-M; at the level of the pisiform bone and scaphoid tubercle)
12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
flattening ratio
Tidsramme: 2, 6, 12 weeks
The flattening ratio was measured only at the mid-tunnel (FR-M). FR was calculated by dividing the horizontal diameter of the nerve by the vertical diameter.
2, 6, 12 weeks
Boston Carpal Tunnel Questionnaire (BQ)
Tidsramme: 2, 6, 12 weeks
The BQ was interviewed-administered to assess the severity of symptoms and functional status.
2, 6, 12 weeks
Median nerve distal motor latency
Tidsramme: 2, 6, 12 weeks
the CMAPs were obtained via surface electrodes placed on the abductor pollicis brevis muscle. The active recording electrode was placed on the muscle belly, and the reference electrode was placed on the tendon insertion. The median nerve was stimulated 8 cm proximal to the active recording electrode. Distal motor latencies were measured from the onset of stimulus artifact to the onset of the CMAP
2, 6, 12 weeks
sensory nerve conduction velocity
Tidsramme: 2, 6, 12 weeks
SNAPs were obtained using an antidromic method and recorded by surface electrodes placed at the proximal and distal interphalangeal joints of the index finger for the median nerve and the same joints of the little finger for the ulnar nerve. The median nerves were stimulated at the wrist at a distance of 14 cm from the wrist to the active electrode. Distal sensory latencies were measured from the onset of the stimulus artifact to the onset of the SNAP. SNCV was calculated dividing the distance of 14 cm by the distal sensory latency.
2, 6, 12 weeks
compound muscle action potential amplitude (CMAP)
Tidsramme: 2, 6, 12 weeks
the CMAPs were obtained via surface electrodes placed on the abductor pollicis brevis muscle. The active recording electrode was placed on the muscle belly, and the reference electrode was placed on the tendon insertion. The median nerve was stimulated 8 cm proximal to the active recording electrode. The amplitude of CMAP were measured from baseline to negative peak.
2, 6, 12 weeks
sensory nerve action potential amplitudes.
Tidsramme: 2, 6, 12 weeks
SNAPs were obtained using an antidromic method and recorded by surface electrodes placed at the proximal and distal interphalangeal joints of the index finger for the median nerve and the same joints of the little finger for the ulnar nerve. The median nerves were stimulated at the wrist at a distance of 14 cm from the wrist to the active electrode. The amplitude of SNAP were measured from baseline to negative peak.
2, 6, 12 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Taipei Veterans General Hospital, Taiwan

Efterforskere

  • Ledende efterforsker: Jia chi Wang, Taipei Veteran General 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)

1. april 2013

Primær færdiggørelse (Forventet)

1. februar 2018

Studieafslutning (Forventet)

1. februar 2018

Datoer for studieregistrering

Først indsendt

16. februar 2017

Først indsendt, der opfyldte QC-kriterier

24. april 2017

Først opslået (Faktiske)

27. april 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. april 2017

Sidst verificeret

1. februar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2016-07-006A; 2012-05-021A

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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