| ObjectiveThis trial is a single-blind,double-dummy,randomized controlled clinical trial.Through analyzing clinical data concluding symptom features,imaging findings,pain levels changes and quality of life improvements,the curative effect and safety of acupotomy for patients with cervicogenic headache(CEH)by releasing soft tissue in the distribution area of cutaneous branches of cervical nerves will be assessed comprehensively and objectively.MethodA total of 60 eligible patients with CEH will be selected from the Department of Acupuncture-Moxibustion of China-Japan Friendship Hospital in October 2017 to December 2019.All patients will be randomly divided into the acupotomy group(n=30)and nerve block group(n=30).The test group participants will accept acupotomy and sham nerve blockade,while the control group participants will accept nerve blockade and sham acupotomy.Choose positive reaction points as actual treatment points,and every patient will receive treatment 1 time per week for 4 weeks.Before treatment,every patient need to be collected general information and clinical feature.The outcomes will be evaluated by changes in Visual Analogue scale(VAS)and verbal rating scale(VRS),the short-form McGill Pain Questionnaire-2(SF-MPQ2)and the 36-item short form Health Survey(SF-36).All patients will receive assessment after treatment and follow-up at 3 months.Finally analyze all data to assess the efficacy of treatments.Results60 cases were included in all.55 patients completed image examitations.59 cases of final clinical efficiency were analyzed because 1 case was discontinued in the nerve block group.1.The imaging findings:cervical vertebra(25.45%),curvature change(65.45%),lumbar foraminal stenosis(21.82%),hyperextension vertebral instability(65.45%),hyperflexion vertebral instability(20.00%),deviation of lateral atlantodental interval(38.18%),spinous process displacement(49.09%),disc herniation(96.30%),nerve root sleeve edema(35.19%).2.VAS score:There were statistically significance difference of VAS scores after treatment and 3 months follow-up compared with pre-treatment both in the acupotomy group and nerve block group(P<0.05).Compared after treatment with 3 months follow-up,there was no statistically significant difference in the acupotomy group(P>0.05)while there was statistically significant difference in the nerve block group(P<0.05).These indicate that the acupotomy and nerve block can both improve the VAS score.There were no significant difference of VAS scores between the two groups after treatment and 3 months follow-up(P>0.05),indicating that the acupotomy and the nerve block have no difference in improving the VAS score.3.VRS scale:There were statistically significance difference of VRS scales after treatment and 3 months follow-up compared with pre-treatment both in the acupotomy group and nerve block group(P<0.05).Compared after treatment with 3 months follow-up,there was no statistically significant difference in the two group(P>0.05),indicating that acupotomy and nerve block both can improve VRS score.There were no significant difference of VRS scales between the two groups after treatment and 3 months follow-up(P>0.05),indicating that the acupotomy and the nerve block have no difference in improving the VRS scale.4.SF-MPQ-2:There were statistically significance difference of SF-MPQ-2 total points after treatment and 3 months follow-up compared with pre-treatment both in the acupotomy group and nerve block group(P<0.05).Compared after treatment with 3 months follow-up,there was no statistically significant difference in the acupotomy group(P>0.05)while there was statistically significant difference in the nerve block group(P<0.05).These indicate that the acupotomy and nerve block can both improve the SF-MPQ-2 total point.There were no significant difference of SF-MPQ-2 total points between the two groups after treatment and 3 months follow-up(P>0.05),indicating that the acupotomy and the nerve block have no difference in improving the SF-MPQ-2 total point.5.SF-36:For the acupotomy group,there were statistically significance difference of body pain(BP)and social fuction(SF)compared before and after treatment(P<0.05),and of role-physical(RP),BP,SF and health transition(HT)3 months follow-up compared with pre-treatment(P<0.05),and of vitality(VT)and HT after treatment compared with 3 months follow-up(P<0.05).For the nerve block group,there were statistically significance difference of RP,general health(GH),SF,role emotional(RE)and HT compared before and after treatment(P<0.05),and of RP,BP,GH,VT,SF,RE and HT 3 months follow-up compared with pre-treatment(P<0.05),and of BP and HT after treatment compared with 3 months follow-up(P<0.05).These indicate that the acupotomy and nerve block both have different degrees of influence on the physical and mental health.There were no significant difference of points of each item of SF-36 between the two groups after treatment and 3 months follow-up(P>0.05),indicating that the acupotomy and the nerve block have no difference in improving the each item of SF-36.6.Clinical efficacy:After the treatment,in the acupotomy group(n=30)5 cases were ineffective,20 were improved,5 were cured,and the total effective rate was 83.33%;in the control group(n=29)6 cases were ineffective,19 were improved,4 were cured,and the total effective rate was 79.31%.There was no statistically significant difference between the two groups(P>0.05).At 3 months follow-up,in the acupotomy group(n=30)5 cases were ineffective,17 were improved,8 were cured,and the total effective rate was 83.33%;in the control group(n=29)2 cases were ineffective,18 were improved,9 were cured,and the total effective rate was 93.10%.There was no statistically significant difference between the two groups(P>0.05).Conclusions1.Releasing the soft tissue of where cutaneous branches of cervical nerves distribute by acupotomy is an effective treatment method for CEH which can significantly improve symptoms of patients and the overall health level,with stable short-term and long-term effiecacy as well.2.Changes in soft tissue tension in the distribution area of cutaneous branches of cervical nerves may be one of the causes of CEH.3.Acupotomy was no significant difference in clinical efficacy compared with nerve block,as well as low risk,quick effect,high patient acceptance and no hormonal side effect.It should be one of the clinically preferred treatment options and worthy of comprehensive promotion at home and abroad.4.Acupotomy for CEH may require clear indications.5.Imaging examination can provide a basis for the diagnosis and treatment for cervicogenic headache,however they have a no value of independent diagnosis.It may be more useful for differential diagnoses and to help clinicians choose the appropriate treatment. |
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