Measuring Reliability of Spine Mobilization in Low Back Pain
11. mai 2026 oppdatert av: University of Kansas Medical Center
This observational study aims to learn how to measure joint motion and tissue response when pressure is applied to the back and examine how the nervous system responds to the applied pressure. This pressure or mobilization technique is a standard care but we currently do not have a method to measure this technique. Through this study, we hope to validate a tool that allows physical therapists to measure the pressure applied during spinal mobilization.
Participants will be asked to:
- Receive spinal mobilization
- Participate in pain threshold testing
- Answer questionnaires
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Faktiske)
50
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Kansas
-
Kansas City, Kansas, Forente stater, 66103
- University of Kansas Medical Center
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
A convenience sample of healthy subjects (faculty and students, n=25) and subjects with chronic low back pain (n=25) will be recruited from the KUMC campus.
Subjects will be excluded if they report lumbar bony or joint pathology (i.e.
osteoporosis, rheumatoid arthritis), lumbar/sacral deformities (i.e.
spondylolisthesis, spina bifida), spinal surgery, have BMI >30, or are pregnant.
Beskrivelse
Inclusion Criteria:
- Healthy individuals without current or recent history (within 6 months) of low back pain
- 18-70 years of age
- BMI between 18.5-29.9
- Ability to read and understand English
- For those with chronic low back pain: 1) low back pain more than 3 months and 2) a minimal pain level of 3 on the 0-10 pain numerical rating scale (NRS) in the last 7 days
Exclusion Criteria:
- Any signs or symptoms of lumbar pathology (as reported by the participant during interview such as low back pain, or lower limb neurological signs)
- History of any spinal surgery
- Lumbar/sacral conditions reported by the subject such as spondylolithesis, spina bifida or spinal fracture
- Bony pathology such as osteoporosis or rheumatoid arthritis as reported by the participant
- Pregnancy
- Spine cancer
- BMI >30
- Unable to lay on stomach
- Resting blood pressure more than 160/90 mmHg
- Currently taking blood thinning medications
- Uncontrolled diabetes
- A medical exclusion from having blood pressure taken such as a peripheral neuropathy
- Low signal to noise ratio fNIRS signal during calibration/setup
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Healthy Participants
Spinal mobilization
|
The application of manual pressure to stiff spinal segments to improve mobility and control pain.
|
|
Chronic Low Back Pain Participants
Spinal mobilization
|
The application of manual pressure to stiff spinal segments to improve mobility and control pain.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Joint displacement as measured by the laboratory methods and from the lumbar mobilization feedback system.
Tidsramme: Change from Baseline (day1) to immediately post-treatment (day 1)
|
The amount of joint motion for a given grade as measured by the laboratory methods and from the lumbar mobilization feedback system.
|
Change from Baseline (day1) to immediately post-treatment (day 1)
|
|
Applied forces as measured by the laboratory methods and lumbar mobilization feedback system
Tidsramme: Change from Baseline (day1) to immediately post-treatment (day 1)
|
The magnitude of force produced by the clinician for each grade as measured by the laboratory methods and lumbar mobilization feedback system
|
Change from Baseline (day1) to immediately post-treatment (day 1)
|
|
Tissue resistance as measured by laboratory methods and the lumbar mobilization feedback system
Tidsramme: Change from Baseline (day1) to immediately post-treatment (day 1)
|
The degree of stiffness of the joint measured as measured by laboratory methods and the lumbar mobilization feedback system
|
Change from Baseline (day1) to immediately post-treatment (day 1)
|
|
Change in muscle activation as measured by electromyography
Tidsramme: Change from Baseline (day1) to immediately post-treatment (day 1)
|
Differences in recorded electromyography (EMG) activity before and after administration of the intervention
|
Change from Baseline (day1) to immediately post-treatment (day 1)
|
|
Change in pain threshold as measured by quantitative sensory testing.
Tidsramme: Change from Baseline (day1) to immediately post-treatment (day 1)
|
The following tests will be used to test sensation threshold before and after grade I - IV mobilization/clinician: pressure pain threshold, conditioned pain modulation, and temporal summation.
|
Change from Baseline (day1) to immediately post-treatment (day 1)
|
|
Brain functional connectivity as measured by functional near infrared spectroscopy
Tidsramme: Change from Baseline (day1) to immediately post-treatment (day 1)
|
Functional near infrared spectroscopy (fNIRS) is a portable, non-invasive, and inexpensive brain imaging method of monitoring cerebral hemodynamic activity.
|
Change from Baseline (day1) to immediately post-treatment (day 1)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
2. oktober 2024
Primær fullføring (Faktiske)
2. februar 2025
Studiet fullført (Faktiske)
2. februar 2025
Datoer for studieregistrering
Først innsendt
12. mai 2025
Først innsendt som oppfylte QC-kriteriene
11. mai 2026
Først lagt ut (Faktiske)
13. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00148661
Plan for individuelle deltakerdata (IPD)
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NEI
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Nei
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