December 27, 2023 – The Journal of Acupuncture and Meridian Studies published a groundbreaking study protocol that is poised to offer fresh insights into the effectiveness and safety of integrating Pharmacopuncture Therapy and Acupotomy with Conventional Korean Medicine Treatments (CKMT) for Lumbar Spinal Stenosis (LSS), a degenerative condition that impairs the lives of many. With the lead author’s identification, Jihun Kim et al., and contributions from institutions like Pusan National University Korean Medicine Hospital and Korea Institute of Oriental Medicine, this research stands at the forefront of innovative treatment modalities in Korean Medicine.
The study is entitled “Effect and Safety of Combining Pharmacopuncture Therapy and Acupotomy in the Treatment of Patients with Degenerative Lumbar Spinal Stenosis: a Study Protocol for a Pragmatic, Assessor-Blinded, Randomized, Controlled Trial” and can be found in the December 31, 2023 issue of the Journal. This work, documented under the DOI: 10.51507/j.jams.2023.16.6.268, provides a meticulous blueprint for what is expected to be a pivotal clinical trial.
Lumbar Spinal Stenosis: An Overview
Lumbar Spinal Stenosis is a condition often found in the aging population where the spinal canal narrows, impinging nerves, and subsequently causing pain, numbness, or weakness primarily in the legs and lower back. The traditional approach has varied, from physical therapy to invasive surgeries, leaving a significant number of patients seeking alternative and complementary medicine options. Korean Medicine has a rich history of utilizing modalities such as acupotomy, a specialized acupuncture technique, and pharmacopuncture, where herbal medicines are injected at acupuncture points, to address conditions like LSS.
An Integrative Approach to Treating LSS
The design of the study is centered around a pragmatic, assessor-blinded, randomized controlled trial with two parallel arms, catering to a cohort of 104 participants diagnosed with LSS. This design underscores the dedication to obtain objectivity and substantial evidence regarding the effectiveness of the treatment modalities combined.
Patients will be randomized in a 1:1 ratio to either an experimental group that receives the combined treatment of pharmacopuncture therapy and acupotomy in addition to CKMT, or a control group which will only receive CKMT. Importantly, the treatments will be administered twice weekly over a 6-week period, entailing a diligent and patient-centric approach to therapy.
Focused Outcomes and Measures of Success
The primary outcome metric, critical to this trial, is the mean change on the 100-mm visual analog scale (VAS) for pain, recorded from baseline to the last treatment session at week 6. Additional assessments will track the mean change in VAS scores at both week 10 and week 14. Other secondary outcomes include measurements of disability, quality of life, and patients’ global impression of change, which will be recorded using validated instruments such as the Zurich Claudication Questionnaire, Roland-Morris Disability Questionnaire, EuroQol 5-dimension 5-level scale, and more.
An ethical consideration and noteworthy component of the trial involve the careful monitoring for adverse events at each visit to ensure patient safety and the overall safety profile of the treatment modalities under scrutiny.
Breaking New Ground in LSS Treatment
Anticipation builds as the outcomes of this trial may have far-reaching implications not only for patients with LSS but also for the broader application of Korean Medicine in treating spinal conditions. The interdisciplinary team, drawing from their diverse backgrounds and areas of expertise, set the stage for an integrative form of healthcare that may challenge the conventional paradigms of treatment for chronic degenerative diseases.
Forging Ahead with Research and Development
Led by esteemed researchers such as Jihun Kim, Chang-Hyun Han, Yeonhak Kim, and their colleagues, the study is a testament to their collaborative spirit and innovation. Sharing a vision to broaden the spectrum of effective treatments for LSS, the team is bringing to light the rich traditions of Korean Medicine with a modern scientific approach.
Funding sources and institutional support, as denoted in the study protocol, include the Clinical Research Coordinating Team of the Korea Institute of Oriental Medicine, highlighting the institutional commitment to advancing research in this field.
Beyond the Horizon
As we await the study results with bated breath, the larger medical community and, more specifically, practitioners and enthusiasts of Korean and Integrative Medicine are hopeful for positive outcomes. The potential for a new, non-invasive treatment option for LSS is on the horizon, and it approaches just as the world increasingly accepts alternative therapies as complements or even successors to conventional medicine.
Detailed reference to this study and the individuals behind it can be found in the Journal of Acupuncture and Meridian Studies. The research team strives to contribute significantly to the repertoire of treatments available for degenerative conditions such as Lumbar Spinal Stenosis and improve the quality of life for those affected.
As a final note, it is crucial to keep in mind the continuously evolving landscape of medicine. This study is not just a culmination of years of meticulous research but also a beacon for potential new breakthroughs in the treatment of chronic conditions through the blending of traditional and modern medical practices.
References
Kim J, Han C-H, Kim Y, Lee T, Yang C, Choi YE, Kang B-K, Kim KH, Yang GY, Kim E. (2023). Effect and Safety of Combining Pharmacopuncture Therapy and Acupotomy in the Treatment of Patients with Degenerative Lumbar Spinal Stenosis: a Study Protocol for a Pragmatic, Assessor-Blinded, Randomized, Controlled Trial. Journal of Acupuncture and Meridian Studies, 16(6), 268-278. DOI: 10.51507/j.jams.2023.16.6.268
Acknowledgments
The authors would like to acknowledge the contributions of the Department of Acupuncture and Moxibustion Medicine at Pusan National University Korean Medicine Hospital and the KM Science Research Division of the Korea Institute of Oriental Medicine for their support in the conception and design of this trial.
