Effectiveness of Joins® for Managing Lumbar Facetogenic Pain (NCT06204952) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effectiveness of Joins® for Managing Lumbar Facetogenic Pain
76 participantsStarted 2024-06-22
Plain-language summary
Obtain informed consent from patients with lumbar facet joint syndrome and, after enrollment, randomly assign them to Group A (Joins®) or Group B (Placebo). According to the allocation in each group, participants are instructed to take Joins® 200mg 1 tablet three times a day or placebo 1 tablet three times a day from day 1. Research subjects visit at 4-week intervals a total of 3 times (4 weeks, 8 weeks, 12 weeks) to collect various measurement variables. Both the test and control groups are observed during the period of taking the investigational medication without any changes or additional facet joint-related procedures (medial branch block, facet joint block). Acetaminophen is allowed as a rescue medication.
Who can participate
Age range19 Years – 80 Years
SexALL
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Inclusion criteria
âś“. Adults between 19 and 80 years of age
âś“. Those diagnosed with lumbar facet joint syndrome through diagnostic posterior medial limb block
âś“. Those with an average 11-point numeric rating scale (NRS) of 4 or more for back pain over the past 24 hours
âś“. Those who voluntarily decided to participate in the study and gave written consent
Exclusion criteria
âś•. Patient refusal
âś•. If the main cause of the current back pain is infectious spondyloarthrosis/arthropathy, ankylosing spondylitis, or stenosis, or if the patient complains or shows signs of local neurological symptoms (e.g., decreased motor power in the lower extremities) due to the underlying disease.
âś•. Patients with moderate to severe lumbar instability requiring surgery
âś•. Cognitive decline to the point where the numeric pain rating (NRS) cannot be understood.
âś•. Severe cardiovascular disease (Systolic BP \>=160 mm Hg or diastolic BP \>=100 mm) or liver (AST/APT increased more than twice normal) or kidney disease (GFR\<60 mL/min/1.73 m2) A person with teeth
What they're measuring
1
Comparison between two groups of change (%) in 11-point NRS