Effectiveness of Joins® for Managing Lumbar Facetogenic Pain (NCT06204952) | Clinical Trial Compass
UnknownNot 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 range
19 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults between 19 and 80 years of age
. Those diagnosed with lumbar facet joint syndrome through diagnostic posterior medial limb block
. Those with an average 11-point numeric rating scale (NRS) of 4 or more for back pain over the past 24 hours
. Those who voluntarily decided to participate in the study and gave written consent
Exclusion criteria
. Patient refusal
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison between two groups of change (%) in 11-point NRS
. Patients with moderate to severe lumbar instability requiring surgery
. Cognitive decline to the point where the numeric pain rating (NRS) cannot be understood.
. 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
. Those with systemic infection or spinal infection
. Those who are allergic to clinical trial drugs or their ingredients
. People with genetic problems such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption