Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT03181802
Eligibility Criteria:
Inclusion Criteria:
* LBP defined as a pain located between the thoracic lumbar hinge and the gluteal sulcus, where pain had evolved over a period of 6 months despite well conducted medical treatment, self-assessed lumbar pain intensity over 50 millimeters long on a visual analogue scale of 100 millimeters (0=no pain; 100=maximal pain),
* having been on sick leave for 60 or more days in the year preceding the inclusion (in order to include patients with high consequences of chronic low-back pain on their work),
* same long-term chronic pain treatment for at least 6 weeks
Exclusion Criteria:
* age under 18 or over 55 years (to avoid secondary causes of low back pain, like spinal tumor),
* ongoing pregnancy or breast-feeding,
* a neuromuscular pathology (myasthenia gravis, amyotrophic lateral sclerosis, myopathy, polymyositis), aminoglycoside treatment at the time of inclusion,
* skin infection at injection points,
* diabetes and alcoholism (in order to avoid other etiologies of chronic pain),
* a history of injecting BoNT-A A,
* anticoagulation treatment, sciatica,
* suspected spinal inflammatory disorder (spondylitis, inflammatory rheumatism, tumoral pathology),
* a failed back surgery syndrome (when surgery failed to relieve low-back pain), - incapacity to stand, cardiorespiratory deficiency which does not allow the isokinetic exploration of the spinal muscles,
* cognitive disorders limiting patient participation,
* conflicts of interest owing to existing pain (unconsolidated work accident, ongoing damage compensation).
* Spine infection, tumour or trauma had been specifically excluded by an MRI done by all patients before the inclusion in the present study.
* No patient was allowed to take opiates during the time of the study,
* facet joint injections were also not permitted during the study period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03181802
Study Brief:
Protocol Section:
NCT03181802