- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02335047
Investigation of the Putative Correlation Between Involuntary Psoas Activity During Passive Flexion of the Trunk at the Hips
The Putative Correlation Between Impaired Hip Flexor Passivity and Common Lower Back Pain: a Pilot Study.
Passive flexion of the trunk (relative to the legs) may be accompanied by contraction of the psoas muscles, even when the subject has been told not to contract any muscles. The psoas contraction is involuntary and cannot be controlled by the subject. This lack of passivity might be concomitant with lower back pain: the impairment may be present when lower back pain is present and/or absent when lower back pain is absent.
The study's primary objective is thus to determine the sensitivity and/or specificity of a clinical test for impaired hip flexor passivity in cases of lower back pain during passive flexion of the trunk (from the supine position,).
The secondary objective is to show that a negative test (after administration of correcting measures) is correlated with a decrease in pain (i.e. pain intensity and the functional repercussions of pain).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age between 18 and 30
- Social security coverage
- Ability to understand the study's objectives, procedures and risks and to provide informed, written consent
- Having been informed about the results of the prior clinical examination.
Exclusion Criteria:
- Past or concomitant infectious or cancerous diseases of the spine
- Vertebral osteosynthesis
- Acute neck or arm pain (recurrent dislocations of the glenohumeral joint, trauma in the previous 12 months, etc.)
- Lower back pain with irradiation of pain below the buttocks
- Known specific lower back pain or pain for which a differential diagnosis suggests an inflammatory, traumatic, cancerous or infectious cause
- Subjects under legal guardianship
- Known pregnancy
- Simultaneous participation in another biomedical research study of a drug or medical device.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: lower back pain
|
Description of the test: the subject lies in the supine position on an exercise mat with his/her feet together.
The subject is told to let his/her arms rest loosely by his/her side (as if they were ropes) and to keep the head aligned with the back.
The examiner pulls the subject into the sitting position by pulling on the subject's wrists, with passive flexion of the trunk until the hip joint is fully flexed..
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Qualitative evaluation of impaired psoas muscle passivity during passive flexion of the trunk at the hips (while sitting).
Tidsramme: Visit 1 (Day 0)
|
Visit 1 (Day 0)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
- A visual analog scale for pain
Tidsramme: - Visit 0 (Day 0: inclusion visit)
|
- Visit 0 (Day 0: inclusion visit)
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Mutter Catherine, MD, Les Hopitaux Universitaires de Strasbourg
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 5898
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