- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03507296
Spinal Kinematics Variability
8 oktober 2021 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
40
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Vaud
-
Lausanne, Vaud, Schweiz, 1011
- University of Lausanne Hospitals
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Chronic low back pain patients
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
Chronic low back pain patients
|
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Asymptomatic subjects
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Spinal kinematics
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain intensity
Tidsram: 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)
|
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Disability
Tidsram: 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)
|
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Disability (ODI)
Tidsram: 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).
|
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Kinesiophobia
Tidsram: 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
Tidsram: 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).
|
|
Back Pain Attitudes Questionnaire
Tidsram: 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).
|
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Fear
Tidsram: Measure 1 (Day 0), Measure 2 (Day 0), Measure 3 (Day 7).
|
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
Tidsram: 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).
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
13 april 2018
Primärt slutförande (Faktisk)
25 september 2020
Avslutad studie (Faktisk)
25 september 2020
Studieregistreringsdatum
Först inskickad
14 mars 2018
Först inskickad som uppfyllde QC-kriterierna
24 april 2018
Första postat (Faktisk)
25 april 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 oktober 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 oktober 2021
Senast verifierad
1 oktober 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- VAR2017
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