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

NCT02335047 | Completed Phase 4

• 1 other identifier: 5898
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Lower Back Pain

Keywords

reliability; clinical test; physical therapy

Outcome Measures

Primary Outcomes (1)

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

  Visit 1 (Day 0)

Secondary Outcomes (1)

• - A visual analog scale for pain

  - Visit 0 (Day 0: inclusion visit)

Study Arms (1)

lower back pain

OTHER

Other: Impaired passivity test

Interventions

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..

lower back pain

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mutter Catherine, MD

  Les Hôpitaux universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: January 9, 2015
• Study Start: January 1, 2015
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: October 2, 2015

Record last verified: 2015-10