Rehabilitation Following Lumbar Disc Surgery
5. november 2012 opdateret af: Julie Fritz, University of Utah
Examining the Effectiveness of a Post-operative Rehabilitation Program Emphasizing Restoration of Multifidus Muscle Function for Individuals Undergoing Lumbar Discectomy: a Randomized Clinical Trial
The proposed study will be a randomized clinical trial designed to determine the most effective physical therapy program for individuals who have undergone lumbar discectomy surgery.
The study will compare two different post-operative physical therapy programs (general strengthening or general + specific strengthening).
Both groups will begin treatment 2 weeks post-surgery.
Subjects in both groups will receive weekly treatment sessions for 8 weeks with a treatment program emphasizing exercises shown to activate the large trunk muscles without imposing potentially harmful compression or shear forces.
The general + specific strengthening group will also receive exercises shown to isolate activation of the deep trunk muscles, in particular the multifidus, with training augmented by the use of diagnostic ultrasound biofeedback.
Patient assessments will be conducted pre- and post-surgery, as well as 10 (post-treatment) and 26 weeks after surgery.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Utah
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Salt Lake City, Utah, Forenede Stater, 84112
- University of Utah, Department of Physical Therapy
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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 til 60 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 18-60 years old
- Diagnosis of LDH based on imaging (MRI or CT scan) of the lumbar spine with concurring clinical examination findings (based on the judgment of the attending neurosurgeon)
- Appropriate surgical candidate based on the opinion of the attending spine surgeon, and scheduled for single-level lumbar discectomy (open or micro-discectomy).
- Able to attend weekly treatment sessions.
Exclusion Criteria:
- Prior surgery to the lumbar spine
- Spondylolytic or degenerative spondylolisthesis present on pre-surgical imaging
- Unable to speak and understand English
- Peri- or post-operative complication (infection, nerve injury, dural tear, vascular injury, etc.) that would limit or delay the ability to participate in post-operative rehabilitation.
- Multi-level surgery or the use of instrumentation during surgery (i.e., lumbar fusion)
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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 1
General exercise.
Participants in this group will perform aerobic exercise, range of motion exercise and general strengthening exercise.
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Exercise: walking, range of motion, and general trunk strengthening with or without specific trunk muscle motor control exercises.
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Eksperimentel: 2
Specific exercise.
Participants in this group will perform aerobic exercise, range of motion exercise, and specific motor control exercises.
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Exercise: walking, range of motion, and general trunk strengthening with or without specific trunk muscle motor control exercises.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Modified Oswestry disability index
Tidsramme: Preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months
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Preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Lumbar multifidus muscle activation as estimated by diagnostic ultrasound imaging
Tidsramme: preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months
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preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Julie Fritz, PT, PhD, ATC, University of Utah
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. april 2009
Primær færdiggørelse (Faktiske)
1. april 2012
Studieafslutning (Faktiske)
1. april 2012
Datoer for studieregistrering
Først indsendt
5. maj 2009
Først indsendt, der opfyldte QC-kriterier
6. maj 2009
Først opslået (Skøn)
7. maj 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. november 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. november 2012
Sidst verificeret
1. november 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 32474
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 .