Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Clinical Prediction Rule for Clinical Lumbar Instability

4. november 2013 oppdatert av: Sheri Silfies, Drexel University

Identifying the Subgroup of Patient With Mechanical Low Back Pain Who Have Clinical Lumbar Instability

The aim of this study is to determine if assessment of additional measures of trunk neuromuscular control will improve the ability to identify patients with low back pain who successfully respond to trunk stabilization exercises.

Question: What clinical characteristics are associated with patients that respond positively to a program of core stabilization exercises?

Hypothesis: Clinical characteristics that show a decrease in trunk motor control will be associated with a positive response to stabilization exercises.

Studieoversikt

Status

Avsluttet

Intervensjon / Behandling

Detaljert beskrivelse

Clinical identification of individuals with mechanical low back pain who would benefit from a program of stabilization exercises has been a struggle for the physical therapy profession. While changes in trunk muscle recruitment and motor control have been linked to patients with chronic low back pain and hypothesized to be adaptations for spinal instability, this has not been systematically established. However, a connection between spinal instability, poor trunk motor control, and low back pain is plausible. The real problem lies with the clinical identification of the subgroup of patients in either the acute or chronic phases of low back dysfunction who would most benefit from this approach to intervention.

In creating their preliminary clinical prediction rule, Hicks et al (2005), looked at many variables including patient demographics and characteristics, hip and trunk motion, special tests for instability, and functional measures of muscle performance. However, measures of the performance of core stabilizing muscles and assessment of trunk dynamic control/ coordination were not included as potential variables. The aim of this study is to determine if assessment of additional measures of trunk neuromuscular control will improve the ability to identify patients with low back pain who successfully respond to trunk stabilization exercises.

Studietype

Intervensjonell

Registrering (Faktiske)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19102
        • Drexel University
      • West Chester, Pennsylvania, Forente stater, 19380
        • Optimum Physical Therapy Associates

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

21 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. duration of the current episode of low back pain less than 3 months,
  2. average pain intensity over past 3 days at least 4 on an 11 point (0 = no pain, 10 = worst pain ever) numeric pain rating scale,
  3. no medical intervention for low back pain in last 6 months,
  4. Oswestry score greater than 25%

Exclusion Criteria:

  1. permanent structural spinal deformity (e.g., scoliosis)
  2. history of spinal fracture or diagnosis of osteoporosis
  3. diagnosis of inflammatory joint disease
  4. signs of systemic illness or suspected non-mechanical LBP (i.e. spinal tumor or infection)
  5. previous spinal surgery
  6. frank neurological loss, i.e., weakness and sensory loss
  7. history of neurologic disease that required hospitalization,
  8. active treatment of another medical illness that would preclude participation in any aspect of the study or any lower extremity injury that would potentially alter trunk movement in standing
  9. leg length discrepancy of greater than 2.5 cm.
  10. pregnancy
  11. vestibular dysfunction

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Low back pain
Individuals with current low back pain.

The 8-week program emphasizes use of specific local stabilizing muscles (transverse abdominis[TrA], lumbar multifidus[LM]) to restore active control to the trunk. Emphasis is on training isometric co-contractions and a progression (3 stages) based upon a motor learning paradigm.

Stage 1: neutral position of the spine and activation of the TrA and LM. Performance feedback is emphasized and monitored through observation and palpation.

Stage 2: maintenance the co-contraction while performing movements of the trunk and the upper and lower extremities. Trunk conditioning is also emphasized. Feedback is gradually reduced.

Stage 3: maintenance of the co-contraction while performing exercises on an unstable surface or during perturbation of the activity. Random practice patterns are used to enhance motor learning.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Oswestry Disability Index
Tidsramme: Baseline, 8 weeks
measure of functional limitation
Baseline, 8 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Numeric Pain Scale
Tidsramme: Baseline, 8 weeks
measure of preceived pain
Baseline, 8 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Sheri P. Silfies, PT, PhD, Drexel University

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. mars 2010

Primær fullføring (Faktiske)

1. august 2012

Studiet fullført (Faktiske)

1. oktober 2013

Datoer for studieregistrering

Først innsendt

10. mars 2010

Først innsendt som oppfylte QC-kriteriene

10. mars 2010

Først lagt ut (Anslag)

11. mars 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

5. november 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. november 2013

Sist bekreftet

1. november 2013

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • DRX18590

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. .

Abonnere