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Completed

NCT Number: NCT02335047

Investigation of the Putative Correlation Between Involuntary Psoas Activity During Passive Flexion of the Trunk at the Hips

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).

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Impaired passivity test

Other

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..

Primary outcomes

  1. Qualitative evaluation of impaired psoas muscle passivity during passive flexion of the trunk at the hips (while sitting).

    Time frame: Visit 1 (Day 0)

Secondary outcomes

  1. - A visual analog scale for pain

    Time frame: - Visit 0 (Day 0: inclusion visit)

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

The Putative Correlation Between Impaired Hip Flexor Passivity and Common Lower Back Pain: a Pilot Study.

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 9, 2015
Registry last updated
Oct 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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