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已发表论文
火针疗法治疗老年人夜间腿部抽筋：一项随机假对照试点试验方案
Authors Wang X , You W, Li Y , Li B, Tian W, Sun J
Received 4 July 2025
Accepted for publication 30 September 2025
Published 17 October 2025 Volume 2025:18 Pages 5467—5480
DOI https://doi.org/10.2147/JPR.S551660
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Dr Houman Danesh
Xiyun Wang,1,2 Wei You,1 Yanpi Li,2 Bin Li,1 Wei Tian,1 Jingqing Sun1
1Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, People’s Republic of China; 2Beijing University of Chinese Medicine, Beijing, People’s Republic of China
Correspondence: Wei You, Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, 23 Meishuguanhou Street Dongcheng District, Beijing, 100010, People’s Republic of China, Email yoyo3535@126.com Jingqing Sun, Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, 23 Meishuguanhou Street Dongcheng District, Beijing, 100010, People’s Republic of China, Email sunjingqing@bjzhongyi.com
Background: Nocturnal Leg Cramps (NLC) are prevalent in older adults, yet safe and effective non-pharmacological treatments are lacking. Fire Needle Therapy (FNT), a Traditional Chinese Medicine (TCM) technique combining thermal and mechanical stimulation, may address this gap.
Methods: This prospective, randomized, participant-and assessor-blind pilot trial will enroll 68 participants (aged 50– 75 years) experiencing ≥ 8 days of NLC monthly. Participants will receive FNT targeting the Ashi points (APs) as treatment or Sham Fire Needle Therapy (SFNT) targeting the non-Ashi points (NAPs) as control twice a week for 4 weeks (1:1 randomization). The primary outcome is the change in the number of days with NLC from baseline (week − 4– 0) to follow-up (weeks 5– 8 and weeks 13– 16). Secondary outcomes include pain severity, cramp duration, sleep quality, quality of life, and muscle stiffness assessed via ultrasound Shear Wave Elastography (SWE). Safety and compliance will be systematically monitored, with analysis following the Intention-to-Treat (ITT) principle.
Discussion: This trial is the first to evaluate the efficacy of manualized FNT protocols for NLC with innovative blinding design and objective biomechanical assessments.
Ethics and Trial Registration: The Research Ethics Committee of the Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University Ethics Committee has approved the study protocol (Approval No. 2024BL02-073-02). This trial was registered at the International Traditional Medicine Clinical Trial Registry (ITMCTR, http://itmctr.ccebtcm.org.cn/). Trial number: ITMCTR2024000325. Registered on August 29, 2024.
Keywords: nocturnal leg cramps, fire needle therapy, randomized controlled trial, sham fire needle therapy, innovative design
1Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, People’s Republic of China; 2Beijing University of Chinese Medicine, Beijing, People’s Republic of China
Correspondence: Wei You, Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, 23 Meishuguanhou Street Dongcheng District, Beijing, 100010, People’s Republic of China, Email yoyo3535@126.com Jingqing Sun, Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, 23 Meishuguanhou Street Dongcheng District, Beijing, 100010, People’s Republic of China, Email sunjingqing@bjzhongyi.com
Background: Nocturnal Leg Cramps (NLC) are prevalent in older adults, yet safe and effective non-pharmacological treatments are lacking. Fire Needle Therapy (FNT), a Traditional Chinese Medicine (TCM) technique combining thermal and mechanical stimulation, may address this gap.
Methods: This prospective, randomized, participant-and assessor-blind pilot trial will enroll 68 participants (aged 50– 75 years) experiencing ≥ 8 days of NLC monthly. Participants will receive FNT targeting the Ashi points (APs) as treatment or Sham Fire Needle Therapy (SFNT) targeting the non-Ashi points (NAPs) as control twice a week for 4 weeks (1:1 randomization). The primary outcome is the change in the number of days with NLC from baseline (week − 4– 0) to follow-up (weeks 5– 8 and weeks 13– 16). Secondary outcomes include pain severity, cramp duration, sleep quality, quality of life, and muscle stiffness assessed via ultrasound Shear Wave Elastography (SWE). Safety and compliance will be systematically monitored, with analysis following the Intention-to-Treat (ITT) principle.
Discussion: This trial is the first to evaluate the efficacy of manualized FNT protocols for NLC with innovative blinding design and objective biomechanical assessments.
Ethics and Trial Registration: The Research Ethics Committee of the Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University Ethics Committee has approved the study protocol (Approval No. 2024BL02-073-02). This trial was registered at the International Traditional Medicine Clinical Trial Registry (ITMCTR, http://itmctr.ccebtcm.org.cn/). Trial number: ITMCTR2024000325. Registered on August 29, 2024.
Keywords: nocturnal leg cramps, fire needle therapy, randomized controlled trial, sham fire needle therapy, innovative design