Fire Needling Therapy versus Manual Acupuncture in Post-Stroke Complex Regional Pain Syndrome of the Upper Limb: Study Protocol for a Pilot Randomised Controlled Trial

Mina Wang,1,2,* Fang Yuan,1,* Xiaobai Xu,1,* Tao Zhang,1 Jing Guo,1 Guiling Wang,1 Linpeng Wang,1 Jingqing Sun,1 Fan Zhang,1 Bin Li1 1Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, 100010, People’s Republic of China; 2Graduate School, Beijing University of Chinese Medicine, Beijing, 100029, People’s Republic of China*These authors contributed equally to this workCorrespondence: Fan Zhang; Bin Li, Email wawndzh@126.com; libin@bjzhongyi.comIntroduction: Post-stroke complex regional pain syndrome (CRPS) is a devastating disease that causes severe physical and emotional consequences. Conventional therapies are limited due to the insufficient benefits and side effects, and fire needling therapy is considered an alternative for post-stroke CRPS of the upper limb.Methods and Analysis: This is a study protocol for a pilot randomised, two-arm, single-centre, clinical trial at Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University. The trial started in March 2023 and is expected to end in December 2024. A total of 60 patients (aged 40– 75 years, male or female) with post-stroke CRPS of the upper limb will be randomly assigned to treatment group (fire needling therapy, 5 sessions per week for 2 weeks) or control group (manual acupuncture, 5 sessions per week for 2 weeks) in a 1:1 ratio using block randomisation and opaque envelopes. Fire needling therapy or manual acupuncture will be performed in ten acupoints. Participants will complete the trial by visiting the research centre at Week 14 for a follow-up assessment. The primary outcome is the response rate. Secondary outcomes include FMA, Barthel Scale/Index (BI), pain threshold (PPT), and muscle elasticity modulus (using shear wave elastography [SWE]). A chi-squared test will be used for response rate. A mixed-effects linear model and a mixed-effects model will be used fo