Fire Needle Therapy for Nocturnal Leg Cramps in Older Adults: A Randomized Sham-Controlled Pilot Trial Protocol

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.