Effectiveness and safety of acupotomy for treating back and/or leg pain in patients with lumbar disc herniation: A study protocol for a multicenter, randomized, controlled, clinical trial.

Abstract

BACKGROUND:

As the number of patients suffering from back and/or leg pain due to lumbar disc herniation (LDH) is increasing in Korea, conservative treatments for patients with LDH have been spotlighted. Although several studies have been published on the use of acupotomy for the treatment of such patients, most of them are only case studies. Therefore, the purpose of this study is to compare the effectiveness and safety of acupotomy to those for manual acupuncture for the treatment of patients with LDH.

METHODS/DESIGN:

This study is planned as a multicenter, parallel design, randomized, controlled, clinical study. One hundred forty-six patients diagnosed with LDH will be randomly assigned to either the acupotomy group or the manual acupuncture group at a 1:1 ratio. Participants in both groups will receive a total of 4 interventions over 2 weeks. An effectiveness assessment based on the outcomes on the visual analog scale (VAS), Roland Morris Disability Questionnaire (RMDQ), Modified-Modified Schober Test (MMST), EuroQol Five Dimensions (EQ-5D), and Patient Global Impression of Change (PGIC) will be conducted at baseline and at 2, 4, and 6 weeks postrandomization. The primary outcome will be the mean change in the VAS for back and/or leg pain 4 weeks postrandomization. Adverse events will be recorded at every visit.

DISCUSSION:

The results of this study will provide evidence for the effectiveness and safety of acupotomy treatment for patients with LDH.

TRIAL REGISTRATION:

Clinical Research Information Service of South Korea (CRIS- KCT0002824), April 24, 2018.

• Authors: Jeong Kyo Jeong, Young Il Kim, Eunseok Kim, Hae Jin Kong, Kwang Sik Yoon, Ju Hyun Jeon, Jae Hui Kang, Hyun Lee, Ojin Kwon, So-Young Jung, Chang-Hyun Han
• Journal: Medicine (Medicine (Baltimore)) Vol. 97 Issue 34 Pg. e11951 (Aug 2018) ISSN: 1536-5964 [Electronic] United States
• PMID: 30142818 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Topics

• Acupuncture Therapy (methods)
• Adult
• Aged
• Back Pain (etiology, therapy)
• Clinical Protocols
• Female
• Humans
• Intervertebral Disc Degeneration (complications)
• Intervertebral Disc Displacement (complications)
• Leg
• Male
• Middle Aged
• Musculoskeletal Pain (etiology, therapy)
• Republic of Korea
• Treatment Outcome
• Young Adult