- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04646018
The Effect of Lumbopelvic Non-Thrust Spinal Manipulation on Individuals With Low Back Pain
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Pennsylvania
-
Reading, Pennsylvania, Forente stater, 19606
- Alvernia University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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.
- Participants will be 18 years of age or older
- 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
- 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
- Participants must report the presence of their low back pain during performance of active forward and/or backward bending in standing
- Participants must demonstrate the ability to communicate in conversational English, that includes speaking, reading, and writing.
Exclusion Criteria:
- Participants who are currently involved in litigation that is directly related to the participant's current episode of low back pain
- Participants with known or suspected pregnancy
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Lumbar Manipulation Group
Group that receives experimental lumbar non-thrust 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
|
Lumbar non-thrust manipulation without force applied
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
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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)
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Change from Baseline to immediately Post Manipulation/Sham to 24-48 hours post session
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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
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Self-assessment disability paper survey
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Change from Baseline to 24-48 hours post session
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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
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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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Joshua Cleland, PhD, Nova Southeastern University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AlverniaU
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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