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

Lower Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335047
• Other study ID #: 5898
• Status: Completed
• Phase: Phase 4
• First received: December 15, 2014
• Last updated: October 1, 2015
• Start date: January 2015
• Est. completion date: February 2015

Study information

• Verified date: October 2015
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lower Back Pain

Intervention

Other:
• Impaired passivity test
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..

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative evaluation of impaired psoas muscle passivity during passive flexion of the trunk at the hips (while sitting).		Visit 1 (Day 0)	No
Secondary	- A visual analog scale for pain		- Visit 0 (Day 0: inclusion visit)	No