Prospective Study of Clinical Utility of Acupuncture in Back Pain (PUCTURE-CV)
7. november 2011 oppdatert av: Group G-6
Prospective Epidemiological Study To Evaluate The Clinical Utility Of Acupuncture In The Treatment Of Back Pain (Study PUCTURE-CV)
The purpose of this study is to evaluate prospectively the effectiveness of acupuncture as adjunctive therapy in the treatment of spinal pain is the three backbone areas: cervical, thoracic and lumbar pain, under conditions of usual clinical practice as the medical acupuncturist performed acupuncture, with and without supplementary pharmacological treatment during the first 4 weeks of follow up.
Studieoversikt
Status
Ukjent
Forhold
Detaljert beskrivelse
Epidemiological, observational, prospective, with two cohorts, naturalistic and non-interventionist study.
The disease to be studied is Back pain (cervical, thoracic or lumbar) caused by musculoskeletal pathologies and previously treated with conventional medical treatment with or without treatment currently.
Studietype
Observasjonsmessig
Registrering (Forventet)
102
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Madrid, Spania, 20010
- I.H. Hospital San Jose
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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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
The study population is patients who go to the Acupuncture Office diagnosed of cervical, thoracic or lumbar pain caused by musculoskeletal diseases, pretreated with pharmacological treatment, they start treatment with acupuncture as adjunctive therapy for symptoms of their disease.
Initially it was estimated that the optimal number of patients included to achieve the objectives of the study is 102 patients
Beskrivelse
Inclusion Criteria:
- Patients of both sexes, aged 18 and over
- Patients diagnosed with back pain: cervical, thoracic or lumbar.
- Patients who has received appropriate medical treatment for their disease: analgesics, anti-inflammatories, or other treatments, but painful and symptoms persist
- Patients that could receive acupuncture treatment in order to reduce the symptoms and reviewed by a medical acupuncturist
- Patients with sufficient cultural and educational level to complete the health questionnaires required in the study
- Patients who have given their written informed consent to participate in the study
Exclusion Criteria:
- Patient with any illness and that medical opinions recommended not to participate in the study
- Patient can not respond to questionnaires administered during the study
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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With usual concomitant treatment
Two observational cohorts of patients will be evaluated: with and without concomitant analgesic/ antiinflammatory drugs.
The objective is evaluate that both therapies (drugs and acupuncture) could be used as adjunctive therapy in order to maximize the analgesia that could be reached
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Without usual concomitant treatment
This group include patients that are not been treated with analgesic drugs at the beginning of the study.
As an observational and naturalistic study any indicated treatment is allowed in any time
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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VAS: Visual Analogic Scale of pain
Tidsramme: 10 weekly visits
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Pain assesment will be evaluated using a Visual Analogic Scale of pain (VAS).
This variable will be evaluated in all 10 visits and it will be showed its evolution (decrease) along the study
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10 weekly visits
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Sheehan Disability Questionnaire
Tidsramme: First Visit (week 1) and Final Visit (week 10)
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Sheehan Disability Questionnaire, this validated questionnaire will be administrated in Visit 1 (Basal) and Visit 10 (Final) and it will be compared if there has been statistical differences between both evaluations
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First Visit (week 1) and Final Visit (week 10)
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Evaluation of the Scale Hospital Anxiety Depression (HAD)
Tidsramme: First Visit (week 1) and Final Visit (week 10)
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Scale Hospital Anxiety Depression (HAD), this scale will be evaluated using a validated questionnaire administrated in Visit 1 (basal) and Visit 10 (Final) and it will be compared if there has been statistical differences between both evaluations
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First Visit (week 1) and Final Visit (week 10)
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Health Questionnaire EuroQol-5D
Tidsramme: First Visit (week 1) and Final Visit (week 10)
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Health Questionnaire EuroQol-5D, this validated questionnaire will be administrated in Visit 1 (Basal) and Visit 10 (Final) and it will be compared if there has been statistical differences between both evaluations
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First Visit (week 1) and Final Visit (week 10)
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Assessment of sleep with the integrated scale MOS (Medical Outcomes Study)
Tidsramme: First Visit (week 1) and Final Visit (week 10)
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Assessment of sleep with the integrated scale MOS (Medical Outcomes Study), this scale will be evaluated using a validated questionnaire administrated in Visit 1 (basal) and Visit 10 (Final) and it will be compared if there has been statistical differences between both evaluations
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First Visit (week 1) and Final Visit (week 10)
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McGill Pain Questionnaire
Tidsramme: 10 weekly visits
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A secondary evaluation of pain suffered by the patients will be evaluated using the validated McGill Pain Questionnaire.
This questionnaire will be adminstrated in all 10 visits and it will be showed its evolution (decrease) along the study
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10 weekly visits
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Valentin Martin, MD, PhD, Grupo G6
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. juli 2010
Primær fullføring (Forventet)
1. juni 2012
Studiet fullført (Forventet)
1. oktober 2012
Datoer for studieregistrering
Først innsendt
28. september 2010
Først innsendt som oppfylte QC-kriteriene
28. oktober 2010
Først lagt ut (Anslag)
1. november 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
8. november 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. november 2011
Sist bekreftet
1. november 2011
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GE6-ACU-2010-01
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