Back to resultsInvestigation of the Putative Correlation Between Involuntary Psoas Activity During Passive Flexion of the Trunk at the Hips
Primary Purpose
Lower Back Pain
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Impaired passivity test
Sponsored by
About this trial
This is an interventional prevention trial for Lower Back Pain focused on measuring reliability, clinical test, physical therapy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
lower back pain
Arm Description
Outcomes
Primary Outcome Measures
Qualitative evaluation of impaired psoas muscle passivity during passive flexion of the trunk at the hips (while sitting).
Secondary Outcome Measures
- A visual analog scale for pain
Full Information
NCT ID
NCT02335047
First Posted
December 15, 2014
Last Updated
October 1, 2015
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT02335047
Brief Title
Investigation of the Putative Correlation Between Involuntary Psoas Activity During Passive Flexion of the Trunk at the Hips
Official Title
The Putative Correlation Between Impaired Hip Flexor Passivity and Common Lower Back Pain: a Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Back Pain
Keywords
reliability, clinical test, physical therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lower back pain
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Impaired passivity test
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
- A visual analog scale for pain
Time Frame
- Visit 0 (Day 0: inclusion visit)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mutter Catherine, MD
Organizational Affiliation
Les Hôpitaux universitaires de Strasbourg
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Investigation of the Putative Correlation Between Involuntary Psoas Activity During Passive Flexion of the Trunk at the Hips
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