Effectiveness of Joins® for Managing Lumbar Facetogenic Pain

NCT06204952 | Not Yet Recruiting

• 1 other identifier: 2309-118-1470
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Facet Joint Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Comparison between two groups of change (%) in 11-point NRS

  4 weeks and 8 weeks after the baseline

• Within-group comparison of change (%) in 11-point NRS

  4 weeks, 8 weeks and 12 weeks after the baseline

• Oswestry disability index (ODI)

  4 weeks, 8 weeks and 12 weeks after the baseline

• PainDETECT/GAD-7/EQ-5D

  4 weeks, 8 weeks, and 12 weeks after the baseline

• Patient's Satisfaction of pain

  12 weeks after the baseline

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Take placebo drug 1T tid for 12 weeks.

Drug: Placebo

Test drug

ACTIVE COMPARATOR

Take Joins®(Clematidis Radix,Trichosanthes Root,Prunella Spike Extract) 1T tid for 12 weeks.

Drug: Joins®(Clematidis Radix,Trichosanthes Root,Prunella Spike Extract)

Interventions

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.

Test drug

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.

Placebo

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Women who have had menarche and have not reached postmenopausal status (≥12 months of consecutive amenorrhea without an identified cause other than menopause) and who have not undergone surgical sterilization (ovarian and/or hysterectomy) are considered women of childbearing potential.
• You must remain abstinent (abstain from sexual intercourse with the opposite sex) or use two medically acceptable forms of contraception. One method of contraception with a low failure rate, defined as less than 1% per year (e.g., oral contraceptives or intrauterine device), and a medically acceptable second method, such as spermicide and condom use by the male partner, should be used. Barrier methods alone are not permitted. Male subjects should use condoms and spermicides during sexual intercourse, and female contraceptive partners should also be careful to use at least one additional method of contraception with a low failure rate as defined above.
• The reliability of sexual abstinence must be evaluated considering the clinical trial period and the test subject's preferred daily lifestyle habits. Periodic abstinence (e.g., date, ovulation, symptom-temperature, or post-ovulation abstinence) and external ejaculation are not acceptable methods of contraception.
• 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

Sponsors & Collaborators

• Jeeyoun Moon: lead

Related Publications (10)

• 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.

  PMID: 16906217 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.

  PMID: 15169547 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.

  PMID: 17325518 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.

  PMID: 26863524 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.

  PMID: 18397385 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.

  PMID: 15315266 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.

  PMID: 12056850 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.

  PMID: 28854768 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.

  PMID: 26987980 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.

  PMID: 26066382 BACKGROUND

Study Officials

• Jee Youn Moon, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jee Youn Moon, MD, PhD

CONTACT

821052992036; jymoon0901@gmail.com

Jeongsoo Kim

CONTACT

821047346422; dreamsu4@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 12, 2024
• Study Start: June 22, 2024
• Primary Completion: January 20, 2026
• Study Completion: April 20, 2026
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share