NCT06204952

Effectiveness of Joins® for Managing Lumbar Facetogenic Pain

Effectiveness of Joins® for Managing Lumbar Facetogenic Pain: A Prospective, Randomized, Double-blind, Placebo-controlled, Pilot Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Jeeyoun Moon · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

First Visit (-4 weeks to 0 weeks, Screening Visit) Check the most severe and average 11-point NRS pain scores in the last 24 hours, as well as the current 11-point NRS pain score. (To be eligible for the study, the average 11-point NRS pain score in the last 24 hours should be 4 or higher.) Conduct demographic survey, confirm concurrent medications and treatments, review medical and surgical history, and perform a physical examination. Measure vital signs. Conduct laboratory tests, and for fertile women, perform a pregnancy test. Perform lumbar X-ray examination. Perform lumbar MRI examination. (This examination can be arranged in advance at an external hospital for the purpose of this study.) Second Visit (0 weeks, Enrollment and Randomization Visit) After confirming the laboratory tests and lumbar X-ray conducted during the last visit, proceed with randomization only if deemed eligible for the study. Measure vital signs. Check the most severe and average 11-point NRS pain scores in the last 24 hours, as well as the current 11-point NRS pain score. Self-assess the questionnaires collected during this visit. Oswestry Disability Index (ODI), PainDETECT, GAD-7, EQ-5D Prescribe the test drug and placebo. Subjects will administer the test drug as follows from the day after the visit: Placebo Group: Administer placebo orally three times a day, one tablet per dose, for 12 weeks. Test Group: Administer Joins® 200 mg orally three times a day, one tablet per dose, for 12 weeks. Confirm concurrent medications and treatments, and check for adverse reactions. Third and Fourth Visits (4 weeks/8 weeks, Treatment Visits) Measure vital signs. Check the most severe and average 11-point NRS pain scores in the last 24 hours, as well as the current 11-point NRS pain score. Self-assess the questionnaires collected during this visit. Oswestry Disability Index (ODI) Subjects return the remaining medication after administration. Confirm compliance and prescribe new test drugs. Confirm concurrent medications and treatments, and check for adverse reactions. Fifth Visit (12 weeks, End of Treatment Visit) Measure vital signs. Check the most severe and average 11-point NRS pain scores in the last 24 hours, as well as the current 11-point NRS pain score. Self-assess the questionnaires collected during this visit. Oswestry Disability Index (ODI), PainDETECT, GAD-7, EQ-5D, PGIC, Satisfaction with Investigational Medication Subjects return the remaining medication after administration. Confirm compliance. Confirm concurrent medications and treatments, and check for adverse reactions. Conduct laboratory tests, and for fertile women, perform a pregnancy test. Sixth Visit (13 weeks, Post-Treatment Follow-up Visit) Measure vital signs. Check for adverse reactions. Conduct laboratory tests, and for fertile women, perform a pregnancy test.

Conditions

• Facet Joint Syndrome

Interventions

Type	Name	Description
DRUG	Joins®(Clematidis Radix,Trichosanthes Root,Prunella Spike Extract)	In patients with facet joint syndrome, Joins® (Clematidis Radix, Trichosanthes Root, Prunella Spike Extract) is administered at a dosage of 1 tablet three times a day for 12 weeks.
DRUG	Placebo	In patients with facet joint syndrome, placebo drug is administered at a dosage of 1 tablet three times a day for 12 weeks.

Timeline

• Start date: 2024-06-22
• Primary completion: 2026-01-20
• Completion: 2026-04-20
• First posted: 2024-01-12
• Last updated: 2024-05-29