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

October 1, 2015 updated by: University Hospital, Strasbourg, France

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: lower back pain
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..

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Qualitative evaluation of impaired psoas muscle passivity during passive flexion of the trunk at the hips (while sitting).
Time Frame: Visit 1 (Day 0)
Visit 1 (Day 0)

Secondary Outcome Measures

Outcome Measure
Time Frame
- A visual analog scale for pain
Time Frame: - Visit 0 (Day 0: inclusion visit)
- Visit 0 (Day 0: inclusion visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Mutter Catherine, MD, Les Hôpitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

December 15, 2014

First Submitted That Met QC Criteria

January 6, 2015

First Posted (Estimate)

January 9, 2015

Study Record Updates

Last Update Posted (Estimate)

October 2, 2015

Last Update Submitted That Met QC Criteria

October 1, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5898

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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