Spinal Kinematics Variability
8. oktober 2021 oppdatert av: Haute Ecole de Santé Vaud
Spinal Kinematics Variability in Healthy Subjects and Patients With Chronic Low Back Pain in Different Functional Activities
This study will test the within and between day variability of spinal kinematics and trunk muscle activity in healthy subjects and chronic low back pain patients during various daily-life activities.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
This study will test the within and between day variability of spinal kinematics and trunk muscle activity in healthy subjects and chronic low back pain patients during various daily-life activities.
Participants will come twice to the motion laboratory.
During the first session, participants will first perform different functional activities (V1), such as sit-to-stand, gait, lifting tasks, stepping up.
Their spinal kinematics will be measured with a camera-based system (VICON) using a multi-segment spinal model and trunk muscles activity will be recorded with surface electromyography.
After a break, participants will have to perform all the functional activities a second time (V2).
These two measures (V1 and V2) will be used to determine the within day variability of spinal kinematics.
Finally, all participants will come one week later (V3) to repeat all the measurements to determine the between day variability.
Studietype
Observasjonsmessig
Registrering (Faktiske)
40
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Vaud
-
Lausanne, Vaud, Sveits, 1011
- University of Lausanne Hospitals
-
-
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
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Chronic low back pain patients
Beskrivelse
Inclusion Criteria:
- sufficient French level to understand the instructions for the tests, the information sheet, the consent form and the questionnaires
- All chronic low back pain patients should present with non-specific low back pain (pain from lower ribs to gluteal folds) for more than 3 months.
Exclusion Criteria:
- pregnancy
- body mass index (BMI) that is above 32
- patients should not have any sign of specific low back pain such as the presence of infection, rheumatological or neurological diseases, spinal fractures, any known important spinal deformities, previous back surgery that limits spinal mobility, tumours
- high level of pain at the time of experiment that prevents repeated movements (severity and irritability)
- other concomitant pain or condition that could compromise the evaluation of spinal kinematics.
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 |
|---|
|
Chronic low back pain patients
|
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Asymptomatic subjects
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Spinal kinematics
Tidsramme: Change between measure 1 and measure 2 (30 minutes later)
|
Range of movement at the lower lumbar, upper lumbar, lower thoracic and upper thoracic joints
|
Change between measure 1 and measure 2 (30 minutes later)
|
|
Trunk muscle activity
Tidsramme: Change between measure 1 and measure 2 (30 minutes later)
|
Surface electromyography of paraspinal, rectus abdominis and external obliques muscles
|
Change between measure 1 and measure 2 (30 minutes later)
|
|
Spinal kinematics
Tidsramme: Change between measure 1 and measure 3 (day 7)
|
Range of movement at the lower lumbar, upper lumbar, lower thoracic and upper thoracic joints
|
Change between measure 1 and measure 3 (day 7)
|
|
Trunk muscle activity
Tidsramme: Change between measure 1 and measure 3 (day 7)
|
Surface electromyography of paraspinal, rectus abdominis and external obliques muscles
|
Change between measure 1 and measure 3 (day 7)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain intensity
Tidsramme: Measure 1 (Day 0), Measure 3 (Day 7)
|
Pain intensity will be quantified by the 11-point Numeric Pain Rating Scale.
The scale range from 0 (no pain at all) to 10 (worst pain).
|
Measure 1 (Day 0), Measure 3 (Day 7)
|
|
Disability
Tidsramme: Measure 1 (Day 0), Measure 3 (Day 7)
|
Disability will be quantified by the Patient Specific Functional Scale.
The scale assessed three relevant activities for the patient and scores each activity between 0 (impossible to realize the activity) to 10 (capable of doing the activity normally).
|
Measure 1 (Day 0), Measure 3 (Day 7)
|
|
Disability (ODI)
Tidsramme: Measure 1 (Day 0), Measure 3 (Day 7).
|
Oswestry Disability Questionnaire.
Score between 0 (no disability) and 100.
|
Measure 1 (Day 0), Measure 3 (Day 7).
|
|
Kinesiophobia
Tidsramme: Measure 1 (Day 0), Measure 3 (Day 7).
|
Tampa Scale of Kinesiophobia.
The total score is between 17 (no kinesiophobia) to 68 (high level of kinesiophobia).
|
Measure 1 (Day 0), Measure 3 (Day 7).
|
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Catastrophizing
Tidsramme: Measure 1 (Day 0), Measure 3 (Day 7).
|
Pain Catastrophizing Scale.
Score between 0 and 52 (high levels of catastrophizing).
|
Measure 1 (Day 0), Measure 3 (Day 7).
|
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Back Pain Attitudes Questionnaire
Tidsramme: Measure 1 (Day 0), Measure 3 (Day 7).
|
Back Pain Attitudes Questionnaire.
Score between 34 (positive attitudes) and 170 (negative attitudes)
|
Measure 1 (Day 0), Measure 3 (Day 7).
|
|
Fear
Tidsramme: Measure 1 (Day 0), Measure 2 (Day 0), Measure 3 (Day 7).
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Fear scale measured before each movement or activity.
Score between 0 (no fear) and 10 (high levels of fear).
|
Measure 1 (Day 0), Measure 2 (Day 0), Measure 3 (Day 7).
|
|
Pain expectation
Tidsramme: Measure 1 (Day 0), Measure 2 (Day 0), Measure 3 (Day 7).
|
Pain expectation scale before each movement or activity.
Score between 0 (no pain expected) and 10 (high levels of pain expected).
|
Measure 1 (Day 0), Measure 2 (Day 0), Measure 3 (Day 7).
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Christe G, Redhead L, Legrand T, Jolles BM, Favre J. Multi-segment analysis of spinal kinematics during sit-to-stand in patients with chronic low back pain. J Biomech. 2016 Jul 5;49(10):2060-2067. doi: 10.1016/j.jbiomech.2016.05.015. Epub 2016 May 20.
- Christe G, Kade F, Jolles BM, Favre J. Chronic low back pain patients walk with locally altered spinal kinematics. J Biomech. 2017 Jul 26;60:211-218. doi: 10.1016/j.jbiomech.2017.06.042. Epub 2017 Jul 5. Erratum In: J Biomech. 2019 Jan 23;83:329.
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)
13. april 2018
Primær fullføring (Faktiske)
25. september 2020
Studiet fullført (Faktiske)
25. september 2020
Datoer for studieregistrering
Først innsendt
14. mars 2018
Først innsendt som oppfylte QC-kriteriene
24. april 2018
Først lagt ut (Faktiske)
25. april 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. oktober 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. oktober 2021
Sist bekreftet
1. oktober 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VAR2017
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