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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Take placebo drug 1T tid for 12 weeks. |
|
| Test drug | Active Comparator | Take Joins®(Clematidis Radix,Trichosanthes Root,Prunella Spike Extract) 1T tid for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Joins®(Clematidis Radix,Trichosanthes Root,Prunella Spike Extract) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison between two groups of change (%) in 11-point NRS | Comparison between two groups of change (%) in 11-point NRS at 12 week visits compared to baseline | 12 weeks after the baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison between two groups of change (%) in 11-point NRS | Comparison between two groups of change (%) in 11-point NRS at 4- and 8-week visits compared to baseline | 4 weeks and 8 weeks after the baseline |
| Within-group comparison of change (%) in 11-point NRS |
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Inclusion Criteria:
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.
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
If you are pregnant or breastfeeding. For women of childbearing potential, those who are unwilling to use a reliable method of contraception during the administration period and for more than 4 weeks after the last administration of the investigational drug
Those with malignant tumor in the lumbar region
Those who have previously undergone lumbar surgery or are scheduled to undergo spine surgery within 12 weeks after screening
Subjects who participated in other clinical trials within 6 months before the first administration of the investigational drug
Other people who are not suitable for this clinical trial according to the researcher's judgment
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jee Youn Moon, MD, PhD | Contact | 821052992036 | jymoon0901@gmail.com | |
| Jeongsoo Kim | Contact | 821047346422 | dreamsu4@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Jee Youn Moon, MD, PhD | Seoul National University Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16906217 | Background | Manchikanti L, Pampati V, Fellows B, Bakhit CE. Prevalence of lumbar facet joint pain in chronic low back pain. Pain Physician. 1999 Oct;2(3):59-64. | |
| 15169547 | Background | Manchikanti L, Boswell MV, Singh V, Pampati V, Damron KS, Beyer CD. Prevalence of facet joint pain in chronic spinal pain of cervical, thoracic, and lumbar regions. BMC Musculoskelet Disord. 2004 May 28;5:15. doi: 10.1186/1471-2474-5-15. |
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| Placebo | Drug | In patients with facet joint syndrome, placebo drug is administered at a dosage of 1 tablet three times a day for 12 weeks. |
|
Within-group comparison of change (%) in 11-point NRS at 4-, 8-, and 12-week visits compared to baseline |
| 4 weeks, 8 weeks and 12 weeks after the baseline |
| Oswestry disability index (ODI) | Oswestry disability index (ODI): Comparison of changes (%) and absolute values at 4-, 8-, and 12-week visits compared to baseline between and within groups (0-45) | 4 weeks, 8 weeks and 12 weeks after the baseline |
| PainDETECT/GAD-7/EQ-5D | PainDETECT/GAD-7/EQ-5D: Comparison of changes (%) and absolute values at the 12-week visit compared to baseline between groups and by time point within groups (0-45) | 4 weeks, 8 weeks, and 12 weeks after the baseline |
| Patient's Satisfaction of pain | Satisfaction with PGIC and clinical investigational drugs (%) | 12 weeks after the baseline |
| Patient's medication | Patient's medication (comparison between groups regarding stable regimen, number of rescue medications taken, and dose taken) | 12 weeks after the baseline |
| 17325518 | Background | Cohen SP, Raja SN. Pathogenesis, diagnosis, and treatment of lumbar zygapophysial (facet) joint pain. Anesthesiology. 2007 Mar;106(3):591-614. doi: 10.1097/00000542-200703000-00024. |
| 26863524 | Background | Enthoven WT, Roelofs PD, Deyo RA, van Tulder MW, Koes BW. Non-steroidal anti-inflammatory drugs for chronic low back pain. Cochrane Database Syst Rev. 2016 Feb 10;2(2):CD012087. doi: 10.1002/14651858.CD012087. |
| 18397385 | Background | Abraham NS, Castillo DL, Hartman C. National mortality following upper gastrointestinal or cardiovascular events in older veterans with recent nonsteroidal anti-inflammatory drug use. Aliment Pharmacol Ther. 2008 Jul;28(1):97-106. doi: 10.1111/j.1365-2036.2008.03706.x. Epub 2008 Apr 7. |
| 15315266 | Background | Lung YB, Seong SC, Lee MC, Shin YU, Kim DH, Kim JM, Jung YK, Ahn JH, Seo JG, Park YS, Lee CS, Roh KJ, Han CK, Cho YB, Chang DY, Kwak WJ, Jung KO, Park BJ. A four-week, randomized, double-blind trial of the efficacy and safety of SKI306X: a herbal anti-arthritic agent versus diclofenac in osteoarthritis of the knee. Am J Chin Med. 2004;32(2):291-301. doi: 10.1142/S0192415X04001941. |
| 12056850 | Background | Choi JH, Choi JH, Kim DY, Yoon JH, Youn HY, Yi JB, Rhee HI, Ryu KH, Jung K, Han CK, Kwak WJ, Cho YB. Effects of SKI 306X, a new herbal agent, on proteoglycan degradation in cartilage explant culture and collagenase-induced rabbit osteoarthritis model. Osteoarthritis Cartilage. 2002 Jun;10(6):471-8. doi: 10.1053/joca.2002.0526. |
| 28854768 | Background | Kim JI, Choi JY, Kim KG, Lee MC. Efficacy of JOINS on Cartilage Protection in Knee Osteoarthritis: Prospective Randomized Controlled Trial. Knee Surg Relat Res. 2017 Sep 1;29(3):217-224. doi: 10.5792/ksrr.17.004. |
| 26987980 | Background | Sae-Jung S, Jirarattanaphochai K. Outcomes of lumbar facet syndrome treated with oral diclofenac or methylprednisolone facet injection: a randomized trial. Int Orthop. 2016 Jun;40(6):1091-8. doi: 10.1007/s00264-016-3154-y. Epub 2016 Mar 18. |
| 26066382 | Background | Cohen SP, Moon JY, Brummett CM, White RL, Larkin TM. Medial Branch Blocks or Intra-Articular Injections as a Prognostic Tool Before Lumbar Facet Radiofrequency Denervation: A Multicenter, Case-Control Study. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):376-83. doi: 10.1097/AAP.0000000000000229. |