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| Analysis of the current status of outcome measures in randomized controlled trials of acupotomy for lumbar disc herniation |
| Hits 176 Download times 36 Received:November 19, 2025 |
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| DOI
10.11656/j.issn.1672-1519.2026.03.08 |
| Key Words
lumbar disc herniation;acupotomy;outcome measures;core outcome set（COS）;randomized controlled trial |
| Author Name | Affiliation | E-mail | | GUO Chen | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China | | | CAO Dongdong | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China | | | GUO Tianci | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China | | | SONG Bowen | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China | | | MA Kuizhi | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China | | | YE Yuntian | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China | | | LIU Aifeng | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China | draifeng@163.com |
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| Abstract
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| [Objective] To analyze the current use of outcome measures in randomized controlled trials（RCTs） of acupotomy for lumbar disc herniation（LDH），so as to provide evidence for developing a core outcome set（COS） in this field. [Methods] From January 2005 to September 2024，all RCTs related to the treatment of LDH by acupotomy in PubMed，Web of Science，the Cochrane Library，EMbase，CNKI，VIP，Wanfang Data，SinoMed，ClinicalTrials.gov，CHiCTR and ITMCTR were comprehensively searched. Relevant outcome measures were extracted，summarized，and analyzed to establish an outcome domain for acupotomy in treating LDH. [Results] A total of 369 RCTs were ultimately included，involving a sample size of 40 430 cases and 107 different outcome measures，which appeared 1 092 times in total. The most common outcome measures were symptoms/signs（75.46%），followed by physical and chemical tests（18.41%），quality of life（2.56%），safety evaluation（2.56%），long-term efficacy indicators（1.37%），traditional Chinese medicine syndrome（1.28%），patient satisfaction（0.64%）and economic indicators（0.18%）. The results indicated that the application of outcome measures in current RCTs on needle-knife treatment for LDH generally had problems such as no distinction between primary and secondary outcomes，lack of objectivity，excessive focus on short-term efficacy，lack of economic indicators，neglect of quality of life，and low attention to safety evaluation. [Conclusion] It is recommended to develop a COS for RCTs of acupotomy for LDH. This will help standardize trial design，improve the rationale for outcome selection，and enhance the reliability of research conclusions. |
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