Spinal Kinematics Variability
8. oktober 2021 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret 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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
40
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Vaud
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Lausanne, Vaud, Schweiz, 1011
- University of Lausanne Hospitals
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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 til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Chronic low back pain patients
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Asymptomatic subjects
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
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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 |
Foranstaltningsbeskrivelse |
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).
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Measure 1 (Day 0), Measure 3 (Day 7)
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Disability
Tidsramme: Measure 1 (Day 0), Measure 3 (Day 7)
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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).
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Measure 1 (Day 0), Measure 3 (Day 7)
|
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Disability (ODI)
Tidsramme: Measure 1 (Day 0), Measure 3 (Day 7).
|
Oswestry Disability Questionnaire.
Score between 0 (no disability) and 100.
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Measure 1 (Day 0), Measure 3 (Day 7).
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Kinesiophobia
Tidsramme: Measure 1 (Day 0), Measure 3 (Day 7).
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Tampa Scale of Kinesiophobia.
The total score is between 17 (no kinesiophobia) to 68 (high level of kinesiophobia).
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Measure 1 (Day 0), Measure 3 (Day 7).
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Catastrophizing
Tidsramme: Measure 1 (Day 0), Measure 3 (Day 7).
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Pain Catastrophizing Scale.
Score between 0 and 52 (high levels of catastrophizing).
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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).
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Back Pain Attitudes Questionnaire.
Score between 34 (positive attitudes) and 170 (negative attitudes)
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Measure 1 (Day 0), Measure 3 (Day 7).
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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).
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Measure 1 (Day 0), Measure 2 (Day 0), Measure 3 (Day 7).
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Pain expectation
Tidsramme: Measure 1 (Day 0), Measure 2 (Day 0), Measure 3 (Day 7).
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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).
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
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)
13. april 2018
Primær færdiggørelse (Faktiske)
25. september 2020
Studieafslutning (Faktiske)
25. september 2020
Datoer for studieregistrering
Først indsendt
14. marts 2018
Først indsendt, der opfyldte QC-kriterier
24. april 2018
Først opslået (Faktiske)
25. april 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. oktober 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. oktober 2021
Sidst verificeret
1. oktober 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- VAR2017
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