The Value of Traction in Treatment of Lumbar Radiculopathy
11. januar 2013 opdateret af: Julie Fritz, Intermountain Health Care, Inc.
The Value of Traction in Treatment of Lumbar Radiculopathy.
The purpose of this study is to determine the effectiveness of adding mechanical traction to standard physical therapy treatments for patients with low back pain.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Despite the opinions of clinical experts that patients who might benefit from traction may represent distinct sub-groups of patients, most studies have not attempted to narrow their inclusion criteria beyond loose definitions of 'acute' or 'chronic' symptoms. While these studies seem to indicate that traction interventions will be of little benefit when administered to large groups of patients without a prior attempt to select which patients are most likely to benefit, they are not sufficient to preclude the possibility that a subgroup of patients may benefit substantially from the intervention. Recent preliminary studies suggest a there exists a subgroup of patients with LBP that is likely to benefit from traction.
The two primary aims of this study are:
- Determine the validity of the previously-identified prediction criteria to identify patients highly likely to benefit from the addition of traction to a standard physical therapy intervention.
- Compare the overall effectiveness of addition of a traction component to a standard physical therapy intervention.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
120
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84119
- Intermountain Healthcare, Rehab Agency
-
-
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 til 60 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Chief complaint of pain and/or paresthesia in the lumbar spine with a distribution of symptoms that has extended distal to the gluteal fold on at least one lower extremity within the past 24 hours based on the patient's self-report.
- Oswestry disability score of at least 20%
- Age at least 18 years and less than 60 years
At least one of the following signs of nerve root compression:
- Positive ipsilateral or contralateral straight leg raise test (reproduction of leg symptoms with straight leg raise < 70 degrees)
- Sensory deficit to pinprick on the ipsilateral lower extremity
- Diminished strength of a myotome (hip flexion, knee extension, ankle dorsiflexion, great toe extension, or ankle eversion) of the ipsilateral lower extremity
- Diminished lower extremity reflex (Quadriceps or Achilles) of the symptomatic lower extremity
Exclusion Criteria:
- Red flags noted in the patient's general medical screening questionnaire (i.e., tumor, metabolic diseases, RA, osteoporosis, spinal compression fracture, prolonged history of steroid use, etc.)
- Evidence of central nervous system involvement, to include symptoms of cauda equina syndrome (i.e., loss of bowel/bladder control or saddle region paresthesia) or the presence of pathological reflexes (i.e., positive Babinski)
- Patient reports the complete absence of low back and leg symptoms when seated
- Recent surgery (< 6 months) to the lumbar spine or buttocks, or any fusion surgery of the lumbar spine or pelvis
- Recent (< 2 weeks) epidural steroid injection for low back and/or leg pain
- Current pregnancy
- Inability to comply with the treatment schedule
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
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Extension oriented treatment approach
Extension exercises.
Subjects are instructed in a progression of extension oriented movements for the lumbar spine.
Manual therapy may be added to further increase extension movement and/or reduction of symptoms.
|
Extension oriented exercises.
Subjects will be instructed in a progression of extension oriented exercises for the lumbar spine
Andre navne:
Mechanical lumbar traction will be applied with subjects in prone utilizing 40-60% of subject's body weight to create a distraction force in the lumbar spine.
Following traction, subjects will be instructed in a progression of extension oriented exercises and manual therapy to increase extension as described for the comparator group.
Andre navne:
|
|
Eksperimentel: Mechanical traction plus extension-oriented treatment
Mechanical lumbar traction will be utilized in addition to extension oriented exercises.
Subjects are also instructed in a progression of extension oriented movements for the lumbar spine.
Manual therapy may be added to increase extension movement and/or reduce radicular symptoms.
|
Extension oriented exercises.
Subjects will be instructed in a progression of extension oriented exercises for the lumbar spine
Andre navne:
Mechanical lumbar traction will be applied with subjects in prone utilizing 40-60% of subject's body weight to create a distraction force in the lumbar spine.
Following traction, subjects will be instructed in a progression of extension oriented exercises and manual therapy to increase extension as described for the comparator group.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Oswestry Disability Index
Tidsramme: Baseline, 6 weeks, 6 months, 1year
|
Baseline, 6 weeks, 6 months, 1year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Global Rating of Change
Tidsramme: Baseline, 6 weeks, 6 months, 1 year
|
Baseline, 6 weeks, 6 months, 1 year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Julie M Fritz, PhD, Intermountain Healthcare; University of Utah
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Thackeray A, Fritz JM, Childs JD, Brennan GP. The Effectiveness of Mechanical Traction Among Subgroups of Patients With Low Back Pain and Leg Pain: A Randomized Trial. J Orthop Sports Phys Ther. 2016 Mar;46(3):144-54. doi: 10.2519/jospt.2016.6238. Epub 2016 Jan 26.
- Fritz JM, Thackeray A, Childs JD, Brennan GP. A randomized clinical trial of the effectiveness of mechanical traction for sub-groups of patients with low back pain: study methods and rationale. BMC Musculoskelet Disord. 2010 Apr 30;11:81. doi: 10.1186/1471-2474-11-81.
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. juli 2009
Primær færdiggørelse (Faktiske)
1. december 2012
Studieafslutning (Faktiske)
1. december 2012
Datoer for studieregistrering
Først indsendt
16. juli 2009
Først indsendt, der opfyldte QC-kriterier
17. juli 2009
Først opslået (Skøn)
20. juli 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
14. januar 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. januar 2013
Sidst verificeret
1. januar 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i nervesystemet
- Smerte
- Neurologiske manifestationer
- Iskias neuropati
- Mononeuropatier
- Sygdomme i det perifere nervesystem
- Neuralgi
- Patologiske Tilstande, Anatomiske
- Knoglesygdomme
- Brok
- Iskias
- Intervertebral diskforskydning
- Radikulopati
- Muskuloskeletale sygdomme
- Rygmarvssygdomme
- Neuromuskulære sygdomme
Andre undersøgelses-id-numre
- 1008586
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 .