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Evaluaing the Effects of Electroacupuncture for Postoperative Pain Relief in Patients With Distal Radius Fracture

13. februar 2020 oppdatert av: China Medical University Hospital

Single-blinded, Randomized Preliminary Study Evaluating the Effects of Electroacupuncture for Postoperative Pain Relief in Patients With Distal Radius Fracture.

Single-blinded, randomized preliminary study evaluating the effects of electroacupuncture for postoperative pain relief in patients with distal radius fracture.

Distal radius fracture is extremely common, and it is about 10% of all fractures in the human body. Therefore, the distal radius is the most frequently fractured part of the upper limbs of the human body. Once the fracture occurs, internal fixation is the main surgical procedure. The postoperative analgesic method is generally oral or injection analgesic. In recent years, electroacupuncture(EA) has been widely used to relieve pain after surgery, and many studies have confirmed that it is effective. However, there is no evaluation of analgesic efficacy after the surgery of distal radius fracture. Therefore, it is hoped that the efficacy of EA for analgesia after the surgery of distal radius fracture is demonstrated by this study. And, the investigators also hope the investigators can reduce the use of painkillers through EA.

Methods: It is expected that 30 patients will be randomly assigned to the following groups: EA group,EA at points; non-point group, EA at non-points, control group without EA

  1. EA group:EA at points after surgery
  2. non-point group: EA at non-points after surgery
  3. Control group: no EA

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Single-blinded, randomized preliminary study evaluating the effects of electroacupuncture for postoperative pain relief in patients with distal radius fracture.

Distal radius fracture is extremely common, and it is about 10% of all fractures in the human body. Therefore, the distal radius is the most frequently fractured part of the upper limbs of the human body. Once the fracture occurs, internal fixation is the main surgical procedure. The postoperative analgesic method is generally oral or injection analgesic. In recent years, electroacupuncture(EA) has been widely used to relieve pain after surgery, and many studies have confirmed that it is effective. However, there is no evaluation of analgesic efficacy after the surgery of distal radius fracture. Therefore, it is hoped that the efficacy of EA for analgesia after the surgery of distal radius fracture is demonstrated by this study. And, the investigators also hope the investigators can reduce the use of painkillers through EA.

Methods: It is expected that 30 patients will be randomly assigned to the following groups: EA group,EA at points; non-point group, EA at non-points, control group without EA

  1. EA group:EA at points after surgery
  2. non-point group: EA at non-points after surgery
  3. Control group: no EA Mode of operation: After the patient has returned to the recovery room, perfom EA, and take the needle after 30 minutes. Perform another 30 minutes after 24 hours, and then statistics.

Acupoint selection:

  1. true acupoints: needles were inserted to Taichong (LR3 ) and Taixi (KI3) contralateral to the operated leg and deqi sensation elicited at acupoints
  2. false point: the needles were inserted to Kunlun(BL60) and Shugu(BL65) contralateral to the operated leg and deqi sensation elicited at acupoints

Data collection:

  1. Record the time required for the first injection of analgesics
  2. The number of doses of oral painkiller used in 36 hours after surgery (count)
  3. The number of doses of injection painkiller used in 36 hours after surgery (count)
  4. Use the visual analog scale (VAS) to assess the patient's pain level

Studietype

Intervensjonell

Registrering (Forventet)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Taiwan
    • No. 2, Yude Rd, North District, Taichung City
      • Taichung, No. 2, Yude Rd, North District, Taichung City, Taiwan, 404
        • Rekruttering
        • China Medical University Hospital

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

20 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Orthopaedic specialist diagnoses distal radius fracture and undergoes internal fixation
  • Age between 20 and 70

Exclusion Criteria:

  • Allergic to painkillers
  • Have a serious heart rhythm
  • epilepsy
  • Severe pulmonary heart disease
  • History of mental illness
  • History of drug abuse
  • received acupuncture treatment within 1 month

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: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: electroacupuncture
electroacupuncture at points after surgery
Annen: elektroakupunktur
akupunktur med strøm
Sham-komparator: electroacupuncture non-point
electroacupuncture at non-points after surgery
Annen: elektroakupunktur
akupunktur med strøm
Ingen inngripen: Control group
only oral or injection painkiller were used after surgery

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
the time required for the first injection of analgesics
Tidsramme: in 36 hours after surgery
Record the time required for the first injection of analgesics
in 36 hours after surgery
the number of doses of injection painkiller
Tidsramme: in 36 hours after surgery
Record the number of doses of injection painkiller
in 36 hours after surgery

Samarbeidspartnere og etterforskere

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

Sponsor

China Medical 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)

5. desember 2019

Primær fullføring (Forventet)

28. november 2020

Studiet fullført (Forventet)

28. november 2020

Datoer for studieregistrering

Først innsendt

22. januar 2020

Først innsendt som oppfylte QC-kriteriene

29. januar 2020

Først lagt ut (Faktiske)

31. januar 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. februar 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. februar 2020

Sist bekreftet

1. februar 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CMUH108-REC1-140

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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