Therapeutic effect of Fu's subcutaneous needling for hemiplegic shoulder pain among stroke survivors Study protocol for a randomized controlled trial

Background: Hemiplegic shoulder pain (HSP) is a frequent complication after stroke and limits patients' physical functioning of the affected arm, thus compromising their quality of life. Fu's subcutaneous needling (FSN) has been widely applied in the treatment of pain diseases in China; however, its efficacy and safety for HSP remain to be elucidated. We therefore conducted a randomized, controlled trial to summarize the current evidence on the effects of FSN on the recovery outcomes of stroke survivors with HSP. Methods: Here, we conduct a study design and protocol of a randomized, blinded, controlled study to evaluate the efficacy and safety of FSN in patients with HSP. A total of 60 patients with numerical rating scale (NRS) score above 1 will be recruited in the trial and randomized into FSN group or usual care (UC) group. Patients in the FSN group will receive FSN treatment combined with UC treatment while patients in the UC group will receive UC treatment alone for 4 weeks. The primary outcomes are changes of NRS at baseline, after the 1st treatment, after the final treatment and 4 weeks after the final treatment. Secondary measurements will be changes of Fugl-Meyer score, constant score, MPQ-SF score, quality of life score, and range of motion at baseline, after the final treatment, and 4 weeks after the final treatment. The safety will also be assessed by monitoring the incidence of adverse events and changes in vital signs during the study. Discussion: Results from this trial will significantly support the application of FSN in the recovery of patients with HSP. If found to be effective and safe, FSN will be a valuable complementary option for patients with HSP.