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Efficacy and Safety Study of Individualized and Standardized Acupuncture Treatment for Low Back Pain

5. april 2012 opdateret af: Dongwoo Nam

Clinical Trial to Evaluate and Compare the Efficacy and Safety of Individualized and Standardized Acupuncture for Low Back Pain Patients: Randomized, Double-blind, Controlled Study

The purpose of this study is to determine whether acupuncture treatment(Individualized & Standardized Acupuncture) is more effective than control (sham acupuncture or no treatment) and also whether individualized acupuncture is more effective than standardized acupuncture.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

To determine whether individualized acupuncture is more effective than standardized acupuncture, 276 Low Back Pain patients will be recruited and randomly assigned to 4 separate groups.

Experimental groups(Individualized Acupuncture Group and Standardized Acupuncture Group) and Control groups (Sham acupuncture and waiting list)

The change of pain and physical functions will be compared among the four groups.

So the efficacy of acupuncture, and the best acupuncture treatment model will be determined. Also in addition, safety and abnormal reactions of acupuncture treatments will be evaluated.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

276

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Korea, Republikken
      • Seoul, Korea, Republikken, 130-872
        • Rekruttering
        • Kyung Hee University Oriental Medicine Hospital
        • Kontakt:
        • Underforsker:
          • Dongwoo Nam, Ph.D

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male and female patients suffering Low Back Pain.
  • Patients classified as Class 1(pain in the lumbar area, without radiation below the gluteal fold and in the absence of neurologic signs) or Class 2(Low back pain with radiation of pain not beyond the knee, no neurological signs) according to the Quebec Task Force System
  • Suffering pain which is more than 40mm on VAS(Visual Analog Scale)
  • Voluntary participants who have completed the consent.

Exclusion Criteria:

  • Low back trauma history within 6 months.
  • Low back surgery history within 6 months.
  • Low back pain caused by malignancy, inflammatory disease, fibromyalgia, vertebral fracture, infection, juvenile scoliosis or congenital malformation.
  • Pain in other parts of the body more severe than low back pain.
  • Mental problems that can influence the pain or results of questionnaire.
  • Diseases that can interfere absorption, metabolism and excretion of medicine.
  • History of alcohol or drug abuse within 12 months of the study.
  • Pregnant, breastfeeding or childbearing aged women who are not using any birth control methods.

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: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Individualized Acupuncture
The patients in this group received individualized acupuncture prescribed by a certified Korean Medicine Doctor with more than 6 years of oriental medicine college education and 2 years of clinical experience. The acupuncture formulas were composed based on the pattern diagnosis, which is an unique diagnosis system of Oriental Medicine.
Procedure: Individuel akupunktur
Behandlingen blev påført to gange om ugen i 20 minutter i 6 uger (12 sessioner)
Eksperimentel: Standardiseret akupunktur
Patienterne i denne gruppe modtog standardiseret akupunkturbehandling med de samme akupunkturpunkter, anvendt af en certificeret koreansk læge med mere end 6 års orientalsk medicin college uddannelse og 2 års klinisk erfaring. Akupunkturformlerne blev sammensat på baggrund af litteraturgennemgang af RCT'er.
Procedure: Standardized Acupuncture
The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions) 8 Acupuncture points, GV4, GV3, BL24(bilateral), BL25(bilateral) and GB30(bilateral) were used for all the patients assigned to this group. Sterile Stainless Steel(25mm x 40mm) disposable acupuncture needles manufactured by Dong-Bang Acupuncture Co.(Korea) were used.
Sham-komparator: Sham akupunktur
Ikke-gennemtrængende akupunkturapparat, Park-sham-akupunktur, blev påført patienterne. Akupunkturens udseende er det samme, men nålene trænger ikke ind i huden.
Procedure: Sham Acupuncture
The treatment was applied twice a week for 6 weeks(12sessions). The sham acupuncture was applied on the 8 same acupuncture points as in the standardized acupuncture group, GV4, GV3, BL24(bilateral), BL25(bilateral) and GB30(bilateral). Each session was 20 minutes long.
Andre navne:
  • Park Sham-enhed
Ingen indgriben: Venter
Ingen interventioner blev anvendt på patienterne i denne gruppe. Der blev kun foretaget vurderinger ved hvert besøg.
Andet: Venter
Ingen interventioner blev anvendt på patienterne i denne gruppe.
Andre navne:
  • Ingen indgreb

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The change of 100mm pain Visual Analog Scale(VAS) after 6 weeks of treatment.
Tidsramme: at baseline and after 6 weeks of treatment.
Visual analog scale (VAS) is a tool used to measure pain. The patient is asked to indicate their perceived pain intensity along a 100 mm horizontal line, where '0' represents 'no pain' and '100', 'unbearable pain'. The change of pain will be reported by comparing the mean VAS before treatment and after the 6 week trearment period.
at baseline and after 6 weeks of treatment.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Roland - Morris Disability Questionnaire
Tidsramme: at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit
Roland - Morris Disability Questionnaire (RMDQ) is scored by adding up the number of items checked by the patients, among the 24 items concerning various disablilities caused by low back pain. The score can therefore vary from 0 to 24. Higher the scores represent worse disabilities.
at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit
SF-36
Tidsramme: at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit
The 36 questions yields an 8-scale health profile. It is useful in monitoring the change in health related quality of life.
at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit
Adverse Events
Tidsramme: at 2nd(baseline), 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th, 12th and 13th(end of study)
Any unpredicted symptoms were checked at each follow up visit and if any, the symptom, time of occurrence, and length of duration were recorded and reported.
at 2nd(baseline), 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th, 12th and 13th(end of study)

Samarbejdspartnere og efterforskere

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

Sponsor

Dongwoo Nam

Samarbejdspartnere

Gachon University Gil Medical Center
Ministry of Health & Welfare, Korea

Efterforskere

  • Studiestol: Jae-Dong Lee, Ph.D, Kyunghee University Medical Center

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

1. oktober 2010

Primær færdiggørelse (Forventet)

1. august 2012

Studieafslutning (Forventet)

1. december 2012

Datoer for studieregistrering

Først indsendt

26. marts 2012

Først indsendt, der opfyldte QC-kriterier

1. april 2012

Først opslået (Skøn)

4. april 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. april 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. april 2012

Sidst verificeret

1. april 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KOMCIRB-02-20101130-02

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 .

Kliniske forsøg med Lændesmerter

Kliniske forsøg med Individuel akupunktur

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Betingelser

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Placeringer

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