- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00010985
Usual Care Vs Choice of Alternative Rx: Low Back Pain
5. marts 2008 opdateret af: National Center for Complementary and Integrative Health (NCCIH)
This study compares two approaches to the management of acute low back pain: usual care (standard benefit) vs. the choice of: usual care, chiropractic, acupuncture or massage therapy (expanded benefit).
480 subjects with uncomplicated, acute low back pain will be recruited from a health maintenance organization, and randomized to either usual care (n=160) or choice of expanded benefits (n=320).
Patients' preferences for individual therapies and expectations of improvement will be measured at baseline and throughout the study.
Subjects randomized to the expanded benefits arm who choose chiropractic, acupuncture or massage will receive up to 10 treatments over a five-week period.
Additional treatments will be available after the fifth week but will require a copayment.
Treatments will be provided by licensed providers who have met strict credentialing criteria.
Chiropractic, acupuncture or massage treatments will begin within 48 hours.
Chiropractic, acupuncture and massage therapy scope of practice guidelines for the treatment of acute low back pain have been developed as have detailed data tracking procedures to be used at each patient visit.
Symptom relief, functional status, restricted activity days, use of health care, and patient and provider satisfaction will be assessed at 2, 5,12, 26 and 52 weeks after initiation of treatment.
Primary outcomes will include: 1) change in symptoms; 2) change in functional status; 3) patient satisfaction; and 4) total utilization of services associated with care for low back pain.
Medical records and the HMO's cost management information system will identify use of services.
It is hypothesized that patients offered their choice of expanded benefits will experience a more rapid improvement in symptoms, a faster return to baseline functional status, a decrease in utilization of conventional medical services, and will be more satisfied with their care.
The study is a direct examination of the effectiveness of an insurance eligibility intervention, not a test of the efficacy of specific, non-allopathic treatment regimens.
The results of this study will provide valuable information to clinicians, patients and third party payers on the relative benefits and costs of an "expanded benefits" treatment option which incorporates chiropractic, acupuncture and massage services for low back pain.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
See brief summary
Undersøgelsestype
Interventionel
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Harvard Medical School Osher Institute
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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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Backpain for less than 21 days
- Backpain within the last 24 hours
- No prior treatment or evaluation for this episode of backpain
- Ability to read and speak English
Exclusion Criteria:
- Not low backpain
- Backpain for >21 days
- Already evaluated for this episode of backpain
- Already treated with acupuncture, chiropractic, massage therapy, or physical therapy for this episode of backpain
- Osteoporosis
- Taking systemic corticosteroids
- Pregnancy
- History of cancer (other than non-melanoma skin cancer)
- Clotting disorders or currently taking anti-coagulant medication
- Severe or disabling co-exiting problem (e.g. fibromyalgia, substance abuse, rheumatoid arthritis, etc.)
- Unable to read or speak English
- History of back or neck surgery within the last 5 years
- History of vertebral fracture or dislocation
- Neurological symptoms suggestive of Cauda Equina Syndrome
- Requires immediate referral to specialist
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
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: David Eisenberg, MD, Harvard Medical School Osher Institute
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. september 1999
Studieafslutning
1. august 2003
Datoer for studieregistrering
Først indsendt
2. februar 2001
Først indsendt, der opfyldte QC-kriterier
2. februar 2001
Først opslået (Skøn)
5. februar 2001
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
7. marts 2008
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. marts 2008
Sidst verificeret
1. marts 2008
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01 AT000144-01M
- R01AT000144-01 (U.S. NIH-bevilling/kontrakt)
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 .