Orthotic Use for Chronic Low Back Pain
30. marts 2017 opdateret af: Jerrilyn Cambron, DC, PhD, National University of Health Sciences
The purpose of this research study is to determine the change in perceived levels of pain and dysfunction in 50 patients with chronic low back pain, following the use of custom-made shoe orthotics for a three month period.
The hypothesis of this study is that custom orthotic intervention will improve the patients' low back pain and dysfunction symptoms.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
50
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Illinois
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Lombard, Illinois, Forenede Stater, 60148
- National University of Health Sciences
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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:
- Males and females must be at least 18 years old.
- Subjects must be symptomatic with current pain between T12 and the Sacroiliac joints with or without radiating pain.
- Symptoms must have been present for at least three months.
Exclusion Criteria:
- Use of custom-made shoe orthotics in the past year
- Brain disorders (i.e.: dementia or Alzheimer's Disease) that would lead to difficulty in questionnaire completion.
- Active conservative care (such as physical therapy or chiropractic care) for the low back received in the last six months (excluding the use of oral medications or daily at-home exercises for general well-being). We do not want to over-treat the patient or have any cross-over effects within this study from previous treatment.
- Not fluent or literate in the English language. We will not be able to provide multiple translators within this pilot study.
- Current or future litigation for low back pain.
- Chronic pain other then low back pain such as fibromyalgia
- Low back surgery in last six months.
- Other conditions that may affect the outcomes of this study or exclude patients from participation in the study, including contraindications to orthotic use.
- Peripheral neuropathy due to disorders such as diabetes.
- Low back or leg pain that is not reproducible.
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Orthotic group
Subjects are asked to wear custom-made shoe orthotics for a 12 week study period.
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Shoe orthotics are devices worn in the shoe to modify the patient's stance and gait.
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Andet: Shoe Orthotic Wait group
The group serves as a cross-over control group.
Subjects are asked to avoid any new therapies for the first 6 weeks of the 12 week study and during the last 6 weeks they are fitted for the custom-made shoe orthotics.
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This group receives the custom-made shoe orthotics at week 6 of the 12 week treatment program rather than week 1.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Visual Analog Scale (VAS)
Tidsramme: Randomization, Week 6, and Week 12
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This scale measures pain on a scale of 0 (no pain) to 10 (worst pain imaginable).
A higher score on this scale indicates a worse outcome or increase in pain.
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Randomization, Week 6, and Week 12
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Oswestry Disability Index (ODI)
Tidsramme: Randomization, Week 6, and Week 12
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This index measures the functional disability of the subject, points on this index can range from 0-50.
A higher numeric value on this scale indicates a worse outcome or increased disability (e.g.
0-10: minimal disability; 11-20: moderate disability; 21-30: severe disability; 31-50: crippling).
Absolute scores are reported in the data table.
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Randomization, Week 6, and Week 12
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jerrilyn Cambron, DC, MPH, PhD, National University of Health Sciences
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. juni 2009
Primær færdiggørelse (Faktiske)
1. februar 2010
Studieafslutning (Faktiske)
1. februar 2010
Datoer for studieregistrering
Først indsendt
11. september 2009
Først indsendt, der opfyldte QC-kriterier
11. september 2009
Først opslået (Skøn)
14. september 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. maj 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. marts 2017
Sidst verificeret
1. marts 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NUHS IRB H-0904
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 .