Efficacy and Safety Study of Individualized and Standardized Acupuncture Treatment for Low Back Pain
5. april 2012 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Forhold
Detaljert 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.
Studietype
Intervensjonell
Registrering (Forventet)
276
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Seoul, Korea, Republikken, 130-872
- Rekruttering
- Kyung Hee University Oriental Medicine Hospital
-
Ta kontakt med:
- Dongwoo Nam, Ph.D
- Telefonnummer: +82-2-958-1827
- E-post: hanisanam@hanmail.net
-
Underetterforsker:
- Dongwoo Nam, Ph.D
-
-
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
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
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: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Behandlingen ble brukt to ganger i uken i 20 minutter i 6 uker (12 økter)
|
|
Eksperimentell: Standardisert akupunktur
Pasientene i denne gruppen fikk standardisert akupunkturbehandling med de samme akupunkturpunktene, brukt av en sertifisert koreansk medisinlege med mer enn 6 års orientalsk medisin høyskoleutdanning og 2 års klinisk erfaring.
Akupunkturformlene ble satt sammen basert på litteraturgjennomgang av RCT.
|
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-penetrerende akupunkturapparat, Park-sham-akupunktur, ble påført pasientene.
Utseendet til akupunkturen er det samme, men nålene trenger ikke inn i huden.
|
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 navn:
|
|
Ingen inngripen: Venter
Ingen intervensjoner ble utført på pasientene i denne gruppen.
Det ble kun gjort vurderinger ved hvert besøk.
|
Ingen intervensjoner ble utført på pasientene i denne gruppen.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Jae-Dong Lee, Ph.D, Kyunghee University Medical Center
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
1. oktober 2010
Primær fullføring (Forventet)
1. august 2012
Studiet fullført (Forventet)
1. desember 2012
Datoer for studieregistrering
Først innsendt
26. mars 2012
Først innsendt som oppfylte QC-kriteriene
1. april 2012
Først lagt ut (Anslag)
4. april 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
6. april 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. april 2012
Sist bekreftet
1. april 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KOMCIRB-02-20101130-02
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .