Efficacy Of Abdominal Acupuncture For Neck Pain In Patients With Cervical Spondylotic Radiculopathy:A Randomized Controlled Trial

Background and ObjectiveNeck pain is a common and challenging health problem with a wide variety of treatments available.Acupuncture is one of the traditional Chinese Medicine treatments and has been used for many years to treat a variety of conditions,especially pain.Abdominal acupuncture is a new method applied in clinical practice in recent decades.It regulates various functions by acupuncture specific acupuncture points on the abdomen to regulate various functions such as viscera and local meridians.It is characterized by safety,painlessness or slight pain.The purpose of this study was to investigate the clinical efficacy of abdominal acupuncture in the treatment of cervical spondylotic radiculopathy(CSR)with a randomized controlled trial(RCT)in Guangzhou,in an attempt to determine its clinical value and provide objective evidence for its clinical application.MethodsThis study was a prospective,patient and assessor-blind,randomized,parallel-group controlled clinical trial in which 70 eligible subjects with CSR were randomly assigned in a 1:1 ratio to either abdominal acupuncture group(treatment group)or placebo group(control group).The trial was fully reviewed and approved by the Ethics Committee and was conducted at the Outpatient Acupuncture Clinic of The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine.All subjects signed an informed consent form before participating in the study.Treatments in this study were performed by qualified acupuncturists strictly in accordance with standardized protocol.The acupuncture points used in the treatment group were Zhongwan(CV12),Guanyuan(CV4),bilateral Shangqu(KI17)and bilateral Huaroumen(ST24).The acupuncture points used in the control group were 1 cun away from the acupuncture points used in the treatment group with treatment method and procedures mimicking the treatment group.Needle retention time for each treatment was 30 minutes in each group and local thermotherapy was performed on the neck by using an electromagnetic effect therapy apparatus in both groups during needle retention period..Both groups treated once every other day,three times a week for two weeks(six treatment sessions in total)and a follow-up period of four weeks after treatment ended.The outcomes were assessed at baseline,at treatment completion,and at four weeks after treatment completion.The primary outcome measure was the mean change in Northwick Park Neck Pain Questionnaire(NPQ)after treatments as compared with baseline.Secondary outcome measures included mean changes in the Visual Analogue Scale(VAS)score for pain and the MOS 36-item Short Form Health Survey(SF-36)score before and after treatments.Other observations included pain-relief medications use and safety assessment.All outcomes were evaluated by intention-to-treat analysis.Statistical analyses were performed by using SPSS 25.0 software.All tests were two-sided,and P<0.05 was considered statistically significant.ResultsA total of 70 patients with CSR aged 23-62 years old were included in the study.There were 10 males and 25 females with average age of 46.94±9.02 years in the treatment group,12 males and 23 females with average age of 48.57±8.74 years in the control group.The average CSR neck pain duration was 5.58±5.18 years in the treatment group and 6.97±6.45 years in the control group.Categorical variables were analyzed by the Pearson chi-square test,and continuous variables were analyzed by independent two-sample t test(Mann-Whitney Utest was used when the assumption of normality and homogeneity of variance was violated).Both groups were comparable and there were no significant differences in demographic characteristics and CSR neck pain history between the two groups(P>0.05).All baseline outcome measeures were balanced for both groups(P>0.05)at baseline.For the primary outcome measure mean NPQ score,both groups were comparable at baseline as there was no significant differences in baseline mean NPQ scores(P=0.765).The two-factor mixed design repeated measures analysis of variance(Mixed ANOVA)for evaluation on changes in mean NPQ scores showed a statistically significant time(at baesline,at treatment completion,and at four weeks after treatment completion)by group(treatment group and control group)interaction(P<0.001).In the control group,one-way repeated measures ANOVA has shown statistically significant differences over time in mean NPQ scores(F=5.033,P=0.018,after Greenhouse-Geisser correction).The mean NPQ scores in the control group decreased at treatment completion and increased slightly at four weeks after treatment completion.The mean NPQ score in the control group was significantly decreased at treatment completion,compared with baseline(P=0.032,after Bonferroni correction).In the treatment group,the changes over time in mean NPQ scores was also statistically significant(F=22.341,P<0.001).The mean NPQ scores in the treatment group over time decreased gradually.The mean NPQ scores in the treatment group were significantly decreased both at treatment completion and at four weeks after treatment,compared with baseline(P<0.001,after Bonferroni correction).The improvement of mean NPQ scores in the treatment group was significantly better than that in the control group.In addition,the change of mean NPQ scores over time in different TCM syndrome differentiation groups were analyzed.The mean NPQ scores for subjects with qi stagnation and blood stasis syndrome in the treatment group has shown statistically significant differences over time(F=1.129,P=0.329).The mean NPQ scores for this group decerased at treatment completion and increased slightly at four weeks after treatment completion.For the secondary outcome measure mean VAS score,both groups were comparable at baseline as the baseline mean VAS scores between the two groups were not statistically significant(P=0.058).The two-factor Mixed ANOVA for evaluation on changes in mean VAS scsores showed a statistically significant time(at baseline,at treatment completion,and at four weeks after treatment completion)by group(treatment group and control group)interaction(P<0.001).In the control group,the one-way repeated measures ANOVA has shown no statistically significant differences over time in mean VAS scores(F=1.129,P=0.329).The mean VAS scores in the control group decreased at treatment completion and increased slightly at four weeks after treatment completion.In the treatment group,the changes over time in mean VAS scores was statistically significant(F=49.939,P<0.001).The mean VAS scores in the treatment group over time decreased gradually.The mean VAS scores in the treatment group were significantly decreased both at treatment completion and at four weeks after treatment,compared with baseline(P<0.001,after Bonferroni correction).The improvement of mean VAS scores in the treatment group was significantly better than that in the control group.In addition,the change of mean VAS scores over time in different TCM syndrome differentiation groups were analyzed.Among them,the changes over time in mean VAS scores was statistically significant for subjects with qi stagnation and blood stasis syndrome in the treatment group(F=21.407,P<0.001).The neck pain intensity for this group also decreased significantly after the first treatment(P=0.004).As for the secondary outcome measure mean SF-36 score,one-way repeated measures ANOVA showed that the time effects for the treatment group in Physical Functioning(PF),Bodily Pain(BP),General Health(GH),Vitality(VT),Social Functioning(SF),Mental Health(MH),Physical Component Summary(PCS),Mental Component Summary(MCS)and Reported Health Transition(HT)have shown statistically significant differences(P<0.05,after Bonferroni correction).The mean scores improved to different extents at treatment completion and four weeks after treatment completion,as compared with baseline.Improvement on mean scroes was better in the treatment group than that of the control group.In addition,the changes over time in mean scores of GH and RE in the control group,and BP,GH,SF,MH,PCS and MCS in the treatment group shown statistically significant for subjects with qi stagnation and blood stasis syndrome(P<0.05).The scores of GH and RE in the control group,and GH and MH in the treatment group increased at treatment completion and decreased at four weeks after treatment.The scores of BP,SF,PCS and MCS in the treatment group continued to improve over time during the study period.The clinical efficacy of the two groups was evaluated according to the improvement of NPQ score at the completion of treatment compared with baseline.The control group has 12 effective cases and 23 ineffective cases,with the total effective rate of 34.3%.The treatment group has 5 significantly effective cases;25 effective cases and;5 ineffevtive cases,with the total effective rate of 85.7%.The Mann-Whitney U test showed a statistically significant difference between the two groups(P<0.05).The clinical efficacy of the treatment group for neck pain in patients with cervical spondylotic radiculopathy was significantly better than that of the control group.The treatment group comprised with subjects with qi stagnation and blood stasis has 2 significantly effective cases and 14 effective cases,with the total effective rate of 100.0%.Fewer subjects in the treatment groups and more subjects in the control group reported use of pain-relief medications over time during the study period.There were no significant differences between both groups on pain-relief medications use after first treatment(P=0.721)and at treatment completion(P=0.074),while significant difference between both groups was shown at four weeks after treatment(P=0.006).Fewer subjects used pain-relief medications in the treatment group at four weeks after treatment.This study showed that abdominal acupuncture for neck pain in CSR was relatively safe,without any serious adverse events noted.ConclusionThe results of this RCT show that the abdominal acupuncture is effective for neck pain of CSR.It has significant effects in improving neck pain function,reducing neck pain intensity and improving patients ' quality of life.The treatment method is safe and its clinical effectiveness is obviously better than that of the control group.Abdominal acupuncture is an effective alternative treatment for neck pain in CSR.