Effectiveness of Joins® for Managing Lumbar Facetogenic Pain

Not Applicable

Not yet recruiting

• Conditions: Facet Joint Syndrome
• Interventions: Drug: Placebo; Drug: Joins®(Clematidis Radix,Trichosanthes Root,Prunella Spike Extract)

• Registration Number: NCT06204952
• Lead Sponsor: Jeeyoun Moon

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.

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.

Study Timeline

• Study First Submitted: 2024-01-03
• Study First Submitted QC: 2024-01-03
• Study First Posted: 2024-01-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-27
• Last Update Posted: 2024-05-29
• Study Start: 2024-06-22
• Primary Completion: 2026-01-20
• Study Completion: 2026-04-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

1. Adults between 19 and 80 years of age
2. Those diagnosed with lumbar facet joint syndrome through diagnostic posterior medial limb block
3. Those with an average 11-point numeric rating scale (NRS) of 4 or more for back pain over the past 24 hours
4. Those who voluntarily decided to participate in the study and gave written consent

Exclusion Criteria

1. Patient refusal

2. 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.

3. Patients with moderate to severe lumbar instability requiring surgery

4. Cognitive decline to the point where the numeric pain rating (NRS) cannot be understood.

5. 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

6. Those with systemic infection or spinal infection

7. Those who are allergic to clinical trial drugs or their ingredients

8. People with genetic problems such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption

9. 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.

10. Those with malignant tumor in the lumbar region

11. Those who have previously undergone lumbar surgery or are scheduled to undergo spine surgery within 12 weeks after screening

12. Subjects who participated in other clinical trials within 6 months before the first administration of the investigational drug

13. Other people who are not suitable for this clinical trial according to the researcher's judgment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Take placebo drug 1T tid for 12 weeks.
Test drug	Joins®(Clematidis Radix,Trichosanthes Root,Prunella Spike Extract)	Take Joins®(Clematidis Radix,Trichosanthes Root,Prunella Spike Extract) 1T tid for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Comparison between two groups of change (%) in 11-point NRS	12 weeks after the baseline	Comparison between two groups of change (%) in 11-point NRS at 12 week visits compared to baseline

Secondary Outcome Measures

Name	Time	Method
Oswestry disability index (ODI)	4 weeks, 8 weeks and 12 weeks after the baseline	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)
Comparison between two groups of change (%) in 11-point NRS	4 weeks and 8 weeks after the baseline	Comparison between two groups of change (%) in 11-point NRS at 4- and 8-week visits compared to baseline
Within-group comparison of change (%) in 11-point NRS	4 weeks, 8 weeks and 12 weeks after the baseline	Within-group comparison of change (%) in 11-point NRS at 4-, 8-, and 12-week visits compared to baseline
PainDETECT/GAD-7/EQ-5D	4 weeks, 8 weeks, and 12 weeks after the baseline	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)
Patient's Satisfaction of pain	12 weeks after the baseline	Satisfaction with PGIC and clinical investigational drugs (%)
Patient's medication	12 weeks after the baseline	Patient's medication (comparison between groups regarding stable regimen, number of rescue medications taken, and dose taken)