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The Effect of Lumbopelvic Non-Thrust Spinal Manipulation on Individuals With Low Back Pain

20. november 2020 opdateret af: Christopher H. Wise, Alvernia University

The Effect of Lumbopelvic Non-Thrust Spinal Manipulation on Muscle Thickness of the Sacral Multifidi, Lumbar Motion, and Self-Reported Pain

The purpose of this experiment is to determine the effects of a non-thrust manipulation procedure on muscle function, spinal mobility, and pain level on those experiencing low back pain (LBP) in a sample of individuals who identify English as their primary language. The rationale for this language criterion is provided in Section 9:F of this application. Muscle function will be measured via the muscle thickness of a deep spinal stabilizing muscle (multifidus, MF) while in both a resting state and during a maximum voluntary contraction (MVC). Spinal mobility will be measured as the active range of motion of both forward and backward trunk bending. Pain level will be a self-report measure recorded during rest and active range of motion.

Hypothesis 1: A non-thrust manipulation procedure will increase the thickness of the sacral multifidus both at rest and during a maximum voluntary contraction

Hypothesis 2: A non-thrust manipulation procedure will result in greater low back active range of motion.

Hypothesis 3: A non-thrust manipulation procedure will result in a reduction in the participant's self-reported pain levels both at rest and during active range of motion movements.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The proposed study aims to determine if the impact of a newly-described manual procedure, that includes a non-thrust force applied to the low back region, has an impact on patient centered-outcomes. Rehabilitation Ultrasound Imaging (RUSI) will be used to determine MF muscle thickness (MT) at rest and during a maximum voluntary contraction (MVC) immediately following application of the manual procedure.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

64

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Reading, Pennsylvania, Forenede Stater, 19606
        • Alvernia University

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:

  1. Participants are individuals with current complaint of low back pain, defined as pain that is present in the region from just below the rib cage to just below the buttocks.
  2. Participants will be 18 years of age or older
  3. Participants must be experiencing an episode of low back pain at the present time that is at any level on a Numerical Pain Rating Scale & Pain Diagram (NPRS) from 1-10
  4. Participants must demonstrate the ability to maintain standing and prone postures for several minutes at a time and perform lumbar active range of motion in a standing position
  5. Participants must report the presence of their low back pain during performance of active forward and/or backward bending in standing
  6. Participants must demonstrate the ability to communicate in conversational English, that includes speaking, reading, and writing.

Exclusion Criteria:

  1. Participants who are currently involved in litigation that is directly related to the participant's current episode of low back pain
  2. Participants with known or suspected pregnancy

  3. Participants with confirmed diagnosis of any of the following conditions:

    • Central nervous system disorder
    • Rheumatoid Arthritis
    • Spinal Fracture
    • Spondyloarthropathy (i.e., Ankylosing Spondylitis)
    • Tumor or infection of the spine

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
Eksperimentel: Lumbar Manipulation Group
Group that receives experimental lumbar non-thrust manipulation
Andet: Lumbar Spine Manipulation
Lumbar non-thrust manipulation is a passive movement that is performed with a rhythm and a grade in a manner in which the patient is able to prevent the technique from being performed.
Sham-komparator: Sham Manipulation Group
Group that receives sham lumbar non-thrust manipulation
Andet: Sham Manipulation
Lumbar non-thrust manipulation without force applied

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in Sacral Multifidus Muscle Thickness
Tidsramme: Change from Pre to immediately Post Manipulation/Sham
Rehabilitation Ultrasound Images of Sacral Multifidus muscle thickness at rest and during a maximal isometric contraction
Change from Pre to immediately Post Manipulation/Sham

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in Lumbar Active Range of Motion
Tidsramme: Change from Pre to immediately Post Manipulation/Sham
Inclinometry of Lumbar Active Range of Motion in Standing
Change from Pre to immediately Post Manipulation/Sham
Changes in Low Back Pain
Tidsramme: Change from Baseline to immediately Post Manipulation/Sham to 24-48 hours post session
Visual Analogue Scale of Low Back Pain (0-10 scale with 0=least pain, 10=worst pain)
Change from Baseline to immediately Post Manipulation/Sham to 24-48 hours post session
Changes in Oswestry Disability Questionnaire (0-100 scale, 0=no disability, 100=bed bound, exaggerating symptoms)
Tidsramme: Change from Baseline to 24-48 hours post session
Self-assessment disability paper survey
Change from Baseline to 24-48 hours post session
Changes in Fear-Avoidance Beliefs Questionnaire (0-96, 96=maximum fear-avoidance beliefs)
Tidsramme: Change from Baseline to 24-48 hours post session
Self-assessment disability paper survey
Change from Baseline to 24-48 hours post session
Changes in Global Rating of Change (-7 to +7 scale, -7=a very great deal worse, +7=a very great deal better)
Tidsramme: Change from Baseline to 24-48 hours post session
Self-assessment disability paper survey
Change from Baseline to 24-48 hours post session

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Alvernia University

Efterforskere

  • Studiestol: Joshua Cleland, PhD, Nova Southeastern University

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 (Faktiske)

20. maj 2020

Primær færdiggørelse (Faktiske)

7. oktober 2020

Studieafslutning (Faktiske)

7. oktober 2020

Datoer for studieregistrering

Først indsendt

5. november 2020

Først indsendt, der opfyldte QC-kriterier

20. november 2020

Først opslået (Faktiske)

27. november 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. november 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. november 2020

Sidst verificeret

1. november 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AlverniaU

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Lændesmerter

Kliniske forsøg med Lumbar Spine Manipulation

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Bosnia & Herzegovina

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner