Clinical Effectiveness of Thread-Embedding Acupuncture in the Treatment of Bell’s Palsy Sequelae: A Randomized, Patient-Assessor-Blinded, Controlled, Clinical Trial
Continuous sequelae due to Bell’s palsy can affect physical functions related to muscles of facial expression such as eating and speaking as well as social aspects of expressing mood and quality of life. Present study is designed as a randomized controlled trial comparing thread-embedding acupuncture with a sham control to assess the clinical effectiveness in the treatment of patients who had Bell’s palsy for longer than three months. A randomized, 1:1 parallel-controlled patient-assessor blinded clinical trial was designed. After randomization, participants were allocated to the thread-embedding acupuncture group or sham thread-embedding acupuncture group. While the intervention group received thread-embedding acupuncture, the control group was given sham thread-embedding acupuncture once a week for eight weeks. Change in the Facial Disability Index (FDI) from baseline to eight weeks was the primary outcome. The secondary outcome was comprised with four-week FDI score change, House-Brackmann grade change, Facial Nerve Grading System 2.0, Sunnybrook Facial Grading System, facial stiffness, lip mobility and patient satisfaction score. Initially, 61 participants enrolled in the study, 56 were selected and randomized. A significant change in the physical FDI score was observed in the thread-embedding acupuncture group at eight weeks (p=0.048). Lip length index in the thread-embedding acupuncture group was significantly better than that in the control group at four weeks (p=0.014). Given that the marginal efficacy driven in this study, the addition of thread-embedding acupuncture to standard acupuncture techniques was not statistically significant in terms of FDI. Further research is need to support the effectiveness of thread-embedding acupuncture.
Keywords - Thread-Embedding Acupuncture, Bell’s Palsy Sequelae, Facial Disability Index, Randomized Controlled Trial.