Effectiveness of Joins® for Managing Lumbar Facetogenic Pain

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.

Timeline

Start

2024-06-22

Primary completion

2026-01-20

Completion

2026-04-20

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

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Indications