Efficacy of JOINS Tablet for Lumbar Spinal Stenosis: Prospective, Randomized, Open-Label Clinical Trial
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Design and Patient Selection
2.2. Randomization and Methods
2.3. Outcome Measurement
2.4. Statistical Analysis
3. Results
3.1. Epidemiological Results
3.2. VAS Score for Low Back and Lower Extremity Radiating Pain Between Two Groups
3.3. Functional Outcome and Quality of Life Between Two Groups
3.4. Adverse Events of All Drugs
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Abbreviations
| RCT | Randomized Controlled Trial |
| VAS | Visual Analog Scale |
| ODI | Oswestry Disability Index |
| RMDQ | Roland-Morris Disability Questionnaire |
| SF-36 | Short Form 36 |
| PCS | Physical Component Score |
| MCS | Mental Component Score |
| NSAIDs | Nonsteroidal Anti-inflammatory Drugs |
| IL | Interleukin |
| TNF-α | Tumor Necrosis Factor Alpha |
| NO | Nitric Oxide |
| MMP | Matrix Metalloproteinase |
| CONSORT | Consolidated Standards of Reporting Trials |
| PRN | Pro Re Nata (as needed) |
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| Inclusion Criteria |
|---|
| (1) Patients diagnosed with spinal stenosis on magnetic resonance imaging with symptoms of lower extremity radiating and low back pain and claudication. |
| (2) Patients not accompanied by other abnormal findings of the spine (infection, tumor, etc.). |
| (3) Patients who fully understand the study and voluntarily given written informed consent. |
| Exclusion Criteria |
| (1) Patients with uncontrolled comorbidities (severe cardiovascular, hepatic, renal disease. |
| (2) Patients taking chronic corticosteroids or anticoagulants. |
| (3) Patients with secondary benefits (worker’s compensation, auto insurance, etc.). |
| (4) Patients with contraindications to all drugs (Opalmon, Naproxen, Pregabalin and JOINS). |
| JOINS Group (n = 50) | Control Group (n = 50) | p-Value | |
|---|---|---|---|
| Age, years | 69 ± 7.165 | 67 ± 6.813 | 0.249 |
| Sex, male/female (n) | 21/29 | 19/31 |
| Time Point | JOINS Group (Mean ± SD) | Control Group (Mean ± SD) | p-Value |
|---|---|---|---|
| Baseline | 6.22 ± 2.252 | 6.82 ± 2.247 | 0.185 |
| 2 weeks | 3.94 ± 2.198 | 6.34 ± 2.237 | <0.001 |
| 6 weeks | 3.74 ± 2.117 | 5.82 ± 1.976 | <0.001 |
| 3 months | 3.28 ± 2.365 | 4.96 ± 2.176 | <0.001 |
| 6 months | 2.54 ± 1.929 | 4.36 ± 2.22 | <0.001 |
| Time Point | JOINS Group (Mean ± SD) | Control Group (Mean ± SD) | p-Value |
|---|---|---|---|
| Baseline | 7.22 ± 1.888 | 7.06 ± 1.845 | 0.669 |
| 2 weeks | 5 ± 2.611 | 6.36 ± 1.893 | 0.004 |
| 6 weeks | 4.32 ± 2.299 | 5.8 ± 1.654 | <0.001 |
| 3 months | 3.28 ± 1.762 | 4.38 ± 2.338 | 0.009 |
| 6 months | 3 ± 1.969 | 4.16 ± 2.084 | 0.005 |
| Outcome | Time Point | JOINS Group (Mean ± SD) | Control Group (Mean ± SD) | p-Value |
|---|---|---|---|---|
| ODI | Baseline | 19.16 ± 7.778 | 22.36 ± 8.403 | 0.051 |
| 3 months | 16.8 ± 7.332 | 19.408 ± 8.201 | 0.097 | |
| 6 months | 15.5 ± 7.651 | 17.34 ± 8.166 | 0.248 | |
| RMDQ | Baseline | 11.02 ± 4.302 | 12.78 ± 5.293 | 0.071 |
| 3 months | 8.8 ± 3.528 | 10.675 ± 6.105 | 0.063 | |
| 6 months | 8.18 ± 4.78 | 9.16 ± 4.938 | 0.316 | |
| SF-36 PCS | Baseline | 30.563 ± 18.293 | 25.576 ± 16.599 | 0.157 |
| 3 months | 39.413 ± 17.623 | 34.088 ± 18.718 | 0.146 | |
| 6 months | 38.908 ± 20.635 | 40.23 ± 21.644 | 0.755 | |
| SF-36 MCS | Baseline | 42.287 ± 21.907 | 36.615± 21.147 | 0.191 |
| 3 months | 46.778 ± 22.193 | 42.842 ± 19.711 | 0.351 | |
| 6 months | 49.889 ± 22.679 | 48.763 ± 20.953 | 0.797 |
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© 2025 by the authors. Published by MDPI on behalf of the Lithuanian University of Health Sciences. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
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Ko, S.; Kim, H. Efficacy of JOINS Tablet for Lumbar Spinal Stenosis: Prospective, Randomized, Open-Label Clinical Trial. Medicina 2025, 61, 1900. https://doi.org/10.3390/medicina61111900
Ko S, Kim H. Efficacy of JOINS Tablet for Lumbar Spinal Stenosis: Prospective, Randomized, Open-Label Clinical Trial. Medicina. 2025; 61(11):1900. https://doi.org/10.3390/medicina61111900
Chicago/Turabian StyleKo, Sangbong, and Heechan Kim. 2025. "Efficacy of JOINS Tablet for Lumbar Spinal Stenosis: Prospective, Randomized, Open-Label Clinical Trial" Medicina 61, no. 11: 1900. https://doi.org/10.3390/medicina61111900
APA StyleKo, S., & Kim, H. (2025). Efficacy of JOINS Tablet for Lumbar Spinal Stenosis: Prospective, Randomized, Open-Label Clinical Trial. Medicina, 61(11), 1900. https://doi.org/10.3390/medicina61111900

