- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00269347
Manipulation, Exercise, and Self-Care for Low Back Pain
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Low back pain remains an important public health problem with serious socioeconomic consequences. Despite the considerable amount of research that has been preformed, there is still a dire need for randomized clinical tiles of high methodological quality. The broad, long-term objective of this interdisciplinary research is to identify effective therapies for low back pain sufferers and increased understanding of this important condition. Building upon the principal investigators' previous collaborative research, this randomized observer-blinded clinical trial will compare the following treatment for patients with nonacute low back pain:
- chiropractic spinal manipulation
- rehabilitative exercise
- self care education Theprimary aim is to examine the relative efficacy of the three interventions in terms of patient rated outcomes in the short-term (after 12 weeks) and the long-term (after 52 weeks) for nonacute low back pain.
Secondary aims include:
- To examine the short and long-term relative cost effectiveness and cost utility of the three treatments.
- To assess if there are clinically important differences between pre-specified subgroups of low back pain patients. Subgroups are based on duration and current episode and radiating leg pain.
- To evaluate if there treatment group differences in objective lumbar spine function (range of motion, strength and endurance) after 12 weeks of treatment and if changes in lumbar function are associated with changes in patient rated short and long-term outcomes.
- To identify if baseline demographic or clinical variables can predict short or long-term outcome.
- To describe patients' interpretations and perceptions of outcome measures used in clinical trials.
Studietype
Registrering
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
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Minnesota
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Bloomington, Minnesota, Forente stater, 55431
- Northwestern Health Sciences University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria: patients are 18-65 years of age; Québec task force classification 1,2,3 and 4 (this includes patients with back pain, stiffness or tenderness, with or without musculoskeletal signs and neurological signs); primary complaint of back pain, with current episode greater than or equal to six weeks duration(this includes subacute and chronic patients for whom the study treatments are an option)
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Exclusion Criteria:
- previous lumbar spine surgery; back pain referred from local joint lesions of the lower extremities or from visceral diseases; progressive neurological deficits due to nerve root or spinal cord compression; aortic and peripheral vascular disease; existing cardiac disease requiring medical treatment; blood clotting disorders; diffuse idiopathic hyperostosis; infectious and noninfectious inflammatory or destructive tissue changes of the lumbar spine; presence of significant infectious disease, or other severe debilitating health problems; substance abuse; ongoing treatment for back pain by other health care providers; pregnant or nursing women; pain score of less than 30 percentage points; pending our current litigation
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Hva måler studien?
Primære resultatmål
Resultatmål |
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Pain (Visual Analog Scale) at baseline, weeks 4,12,26,52
|
Sekundære resultatmål
Resultatmål |
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Disability (Modified Roland Scale) at baseline, weeks 4,12,26,52
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General Health (SF-36) at baseline, weeks 4,12,26,52
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Improvement (7 point scale) at baseline, weeks 4,12,26,52
|
Disability (NHIS) at baseline, weeks 4,12,26,52
|
Bothersomeness (7 point scale) at baseline, weeks 4,12,26,52
|
Frequency (7 point scale) at baseline, weeks 4,12,26,52
|
Satisfaction (5 point scale) at baseline, weeks 4,12,26,52
|
Depression (CES-D) at baseline, weeks 4,12,26,52
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Medication use at baseline, weeks 4,12,26,52
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Fear-avoidance (FABQ) at baseline, weeks 4,12,26,52
|
Lumbar range of motion at baseline, weeks 4,12,26,52
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Lumbar strength and endurance at baseline, weeks 4,12,26,52
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Health care costs and utilization at baseline, weeks 4,12,26,52
|
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Haanstra TM, Hanson L, Evans R, van Nes FA, De Vet HC, Cuijpers P, Ostelo RW. How do low back pain patients conceptualize their expectations regarding treatment? Content analysis of interviews. Eur Spine J. 2013 Sep;22(9):1986-95. doi: 10.1007/s00586-013-2803-8. Epub 2013 May 10.
- Bronfort G, Maiers MJ, Evans RL, Schulz CA, Bracha Y, Svendsen KH, Grimm RH Jr, Owens EF Jr, Garvey TA, Transfeldt EE. Supervised exercise, spinal manipulation, and home exercise for chronic low back pain: a randomized clinical trial. Spine J. 2011 Jul;11(7):585-98. doi: 10.1016/j.spinee.2011.01.036. Epub 2011 May 31.
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- R18HP10009
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. .
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