Ultrasound of the Thoracolumbar Fascia for Diagnosing Chronic Low Back Pain

Not Applicable

Terminated

• Conditions: Low Back Pain

• Registration Number: NCT04843800
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-4-7
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Terminated
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Inclusion Criteria:<br><br> - Ongoing low back and/or referred pain (non-specific pattern) above or just below the<br> gluteal fold of at least 3/10 on a numerical pain rating scale (NRS), for at least 3<br> months;<br><br> - Pain has resulted in a problem on at least 50% of the days in the past 6 months;<br><br> - Only use of oral non-steroidal anti-inflammatory drugs for pain treatment in the 4<br> weeks before treatment;<br><br> - Willingness to commit to treatment sessions (acupuncture, chiropractic therapy or<br> therapeutic massage) and to follow-up visits.<br><br>Exclusion Criteria:<br><br> - Back pain attributable to a specific, recognizable, known pathology:<br><br> 1. protrusion or prolapse of 1 or more intervertebral discs with concurrent<br> neurological symptoms;<br><br> 2. radicular pain (sciatica);<br><br> 3. infectious spondylopathy;<br><br> 4. low back pain caused by inflammatory, malignant, or autoimmune disease;<br><br> 5. congenital deformation of the spine (except for slight lordosis or scoliosis);<br><br> 6. compression fracture caused by osteoporosis;<br><br> 7. spinal stenosis;<br><br> 8. spondylolysis or spondylolisthesis;<br><br> 9. Pregnancy;<br><br> - History of spinal surgery;<br><br> - History of pelvis or hip fractures;<br><br> - Acupuncture, spinal manipulation or therapeutic massage for back pain within the<br> past year;<br><br> - Severe clotting disorders or anticoagulant therapy;

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
% shear strain change.

Secondary Outcome Measures

Name	Time	Method
Quantitative ultrasound marker 'µ' change.;Quantitative ultrasound marker 'a' change.;Quantitative ultrasound marker '?' change.;Brief Pain Inventory short form 'pain severity' change.;Brief Pain Inventory short form 'pain interference' change.;Oswestry Disability Index (ODI) change.;PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health Scale change.