| Background:Recently, Acupuncture has become an effective clinical therapeutic method in curing peripheral facial paralysis, referring to facial paralysis caused by diseased motor nerve fibers. This research, using thermal-Bian-cone therapy as the subject, tend to combining acupuncture and thermal-Bian-cone together to cure peripheral facial paralysis, basing on the previous studies of other research groups, so as to provide a new treatment by observing its clinical effects.Object:Observe the clinical effects of treating convalescent peripheral facial paralysis with acupuncture and thermal-Bian-cone therapy, comparing with that of using regular acupuncture treatment in order to provide new treatments for curing peripheral facial paralysis and reference clinical doctors.Methods:1.subjects:Using randomized controlled trial, this research stochastically separates the60patients with peripheral facial paralysis, colleting from Hongkong Bosong Traditional Chinese Medicine Clinic and Acupuncture and Moxibustion Department of Nanfang hospital during the period of time from January2013to December2013, into two groups including treatment group(n=30, using acupuncture along with thermal-bian-cone therapy) and control group(n=30, using regular acupuncture therapy), according to the random number table generated from SPSS18.0. Meanwhile, single-blind method is conducted, following the clinic-trail principles of separating researchers, physicians and statisticians.2.Diagnostic criteria:The diagnostic criteria referring to the Neurology(2nd Edition, People’s Medical Publishing House).3.Inclusion criteria:Participants were considered eligible for inclusion if they:1) met the diagnostic criteria given above;2) aged from18to70;3) whose course of disease is in comvalescent stage(onset time:1-2weeks ago)4) the first time suffering peripheral facial paralysis5) had no fear of acupuncture, and can ensure treatment adherence according to research plan.4.Exclusion criteriaParticipants were excluded if they:1) Also suffer severe cardiac and cerebrovascular diseases;2) had a previous history of mental illness, or an existing physical illness;3) are pregnant;4) Have their peripheral facial paralysis secondary to acute polyneuroradiculitis, Infringement of temporal bone tumors, parotitis or brain trauma etc.5) suffer dysfunction of blood coagulation; 6) had received medication or other treatment for peripheral facial paralysis before this trail;7) could not complete treatment in accordance with the study requirements.5. Response Evaluation Criteriaa. Clinical Response EvaluationAdopting House-Brackmann Scale, evaluate the clinical response of two groups of the patients both before and after the treatment.Complete Recovery:achieving Ⅰ degree of House-Brackmann Scale. Forehead lines and nasolabial sulcus of Double sides regains symmetry, frown and close eyes functionally, can hold the breath while doing cheek-bulging, no food debris in between the teeth and cheeks while eating and facial expressions function normally, no mouth askew when speaking and laughing;Marked Effect:achieving Ⅱ degree of House-Brackmann Scale. Forehead lines and nasolabial sulcus of Double sides almost regains symmetry, cannot frown and close eyes completely, can hold the breath while doing cheek-bulging, no food debris in between the teeth and cheeks while eating and facial expressions function normally with only a little mouth distortion when speaking and laughing;Improve/Better:Improved from IV or V degree to Ⅲ degree after the treatment;Fail:remain Ⅳ degree or worsen after the trail.b.Main Symptoms EvaluationAccording to "40-point method", proposed by Japanese facial nerve research institute, we evaluate the level of the facial-nerve numbness, observe10facial movements, for example, standstill, frowning, slightly closing eyes, shutting eyes tightly, closing the affected eyes, moving nosewings, bulging cheeks, showing teeth, whistling, sipping mouth etc. the numbness is classified into3level:no obvious difference between two sides(4points); the function of effected side is weaken(2 points); the effected side fail to function(0point).6. Falls off and Excluding CriteriaPatients who cannot complete the trail due to any reason, making the case data collecting impossible.1) Patients who take other medication and/or treatment that are not provided in the trail by themselves;2) Cases that fail the inclusion criteria but were included by mistake;3) Patients who suffer no side effect of the medication, but have to cease the treatment due to other unpredictable reasons/incidents (have to quit the trail because of other diseases, immigrate to another city/country etc.).7. Treatment:a. Control Group(conduct regular treatment group)Selecting Cuanzu, Yangbai, Sibai, Quanliao, Jiache, Dicang, Yifeng, Hegu etc. as the main acupoints, along with Fengchi, Quchi, Yingxiang, Shuigou, Chengjiang, Zusanli according differentiation. After regular sterilizating the acupuncture area, using disposable sterilized acupuncture needle(Brand:Tianxie), size0.25x30mm for head facial acupoints, and size0.30x40mm for acupoints on limbs. Operation:While patients lying on their back, select acupoints Cuanzu, Yangbai, Sibai, Quanliao, Jiache, Dichang, Yifeng etc. on the effected side to apply regular Acupuncture treatment.b.Treatment Group(using acupuncture along with thermal-Bian-cone therapy)Before applying regular acupuncture treatment which is identical to the Control group, use thermal-Bian-cone therapy when the patients lying on their back. There should be an interval of5minutes between these two treatments.c. Emergency HandlingAdjust the orientation of the needle-inserting, why the pain occurs due to acupuncture at the pores. What’s more, apply pressure on the bleeding point, if the vessels are injured during the acupuncture.8. Observing Method and Measurement Criteriaa. Observing CycleObservation period was2treatment courses (40days) in each group, the patients that quit during the trail will be excluded immediately.b. Measurement Criteria1) the number of the cases in which the patients recover completely within the observing Cycle;2) the clinical affect at the end of the observation cycle;3) the comparison between the symptoms before and after the treatment in both group when the trail is over;4) the side effect response that happened during the trail, for instance, bleeding and bruising etc.9. Statistical TreatmentAll the Observing data will be arranged by someone who is not in the trail, using Software SPSS18.0to run the data. The regular data and the comparison of the value of every main symptoms will be calculated through independent sample t-test, while the comparison of the clinical effect will be calculated through chi-square test. Considering the difference that exist between the group of patients, the change value between before and after would be used as to show the influence of the treatment. The result will be statistically significant if the score level is lower than0.05.Results:The obvious cure rate of the treatment group (60.0%) had no significantly increased in the data of the control group (40.0%) after the treatment (P>0.05). All scores of "40-point method " of2groups were all improved compared to that before treatment (P<0.05). Except for the scores of whistling, forehead lifting, grinning and zipping mouth were higher than that in the control group (P<0.05), and the other scores of "40-point method" were no statistical significance (P>0.05).Conclusion:Both of thermal-Bian-cone therapy combined with acupuncture and acupuncture could treat the peripheral facial paralysis in convalescence, however, the obvious effective rate of the treatment group higher than the control group, especially in some clinical symptoms like whistling, forehead lifting, grinning and zipping mouth. |
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