Lee, Daniel C. C (2008) Using silver spike point needle-free electro-acupuncture for postoperative pain management. Research Master thesis, Victoria University.

Abstract

The severity of postoperative pain is affected by many factors including the patient’s age, sex, personality, knowledge of and confidence in the procedure, attitude of the staff, and the individual's physiological condition. The same procedure can produce different degrees of postoperative pain in different patients. Even though, in most cases, upper abdominal or thoracic surgery causes severe postoperative pain, superficial operations still cause mild postoperative pain. Patients usually feel the most pain in the first few hours after surgery. Postoperative pain can result in irritability, insomnia, increased heart rate, hypertension, excessive perspiration, overactive metabolism, tachycardia, diaphoresis, mydriasis, pallor and increased myocardial oxygen consumption. In patients with coronary artery disease, postoperative pain can result in myocardial ischemia and possible infarction that in turn may delay postoperative recovery. Intravenous patient-controlled analgesia (PCA) is an accepted method to relieve postoperative pain. Opioids are often used as an analgesic for severe pain management. Possible adverse effects are respiratory depression, constipation, vomiting, gastroparesis, and central nervous system depression including somnolence and consciousness disturbance. Opioid-related side effects often occur post-operatively, and are related to the total dosage of opioid medication. Non-pharmaceutical products can be an alternative in the treatment of post-operative pain and produce less adverse effects. Acupuncture’s ability to control pain has been documented for thousands of years and has become well-accepted in modern Western medicine. Electro-stimulation has a postoperative pain relieving effect when applied as either electro-acupuncture (EA), transcutaneous nerve stimulation (TENS) or Silver Spike Point (SSP) therapy. SSP as needle-free EA and has been shown to have a similar analgesic effect to standard EA, where electrical stimulation is applied to needles that have been inserted into acupuncture points, and a superior effect than TENS. The acupuncture analgesic mechanism remains unclear in spite of successful clinical applications and recognition by WHO. This study investigated SSP needle-free EA's role in managing of postoperative pain and in reducing the adverse side effects of opioids. Acupuncture has generated much interest in western countries like Australia, and is considered a rather safe clinical treatment method for a wide range of disorders. However, in clinical applications, there are some contraindications and complications with using needles. SSP needle-free EA offers many benefits over standard acupuncture treatment such as: reduced hazardous waste, no skin penetration and therefore a reduced risk of infection. SSP EA provides a range of stimulation types that are particularly suitable for sensitive patients including young children and the elderly. A particular advantage of SSP EA is that it can be safely used on acupuncture points all over the body, whereas incorrect acupuncture needling over major organs and the spinal cord can cause serious problems. In this study, we examined the effects of Silver Spike Point (SSP) therapy, also known as needle-free electro-acupuncture (EA), at the classical bilateral acupuncture point Zusanli (ST36) on postoperative pain and opioid-related side effects following hysterectomy. Based on a double blind, sham and different intervention controlled clinical experimental design, four groups of randomised patients were enrolled into the study as subjects. Group 1 was assigned as the control group; Subjects in group 2 were applied SSP electrode at a sham acupuncture point; Group 3 received SSP stimulation at 100 Hz and Group 4 received SSP stimulation by a mixture of at 3 Hz, 10 Hz, and 20 Hz on Zusanli (ST36). It was planned that each group was to consist of 25 women who had undergone hysterectomy. The research evaluated the analgesic effect of SSP needle-free EA for post-operative pain relief of women who had been given a hysterectomy, and comparing the difference between high frequency and low frequency stimulation. The hypothesis was that the groups that received the double treatment of SSP needle-free EA (both pre- and post-surgery) at acupuncture point Zusanli (ST36) would demonstrate increased analgesic relief over a longer period of time, i.e. longer duration before requiring the first PCA dose, fewer PCA doses required, and fewer opioid related side effects compared to the sham and control groups. In addition, the group that received the low frequency treatment would achieve better analgesic relief compared to the high frequency treatment, the sham, and the control groups. The Results were analyzed using a One-way analysis of variance (ANOVA) for Visual Analogue Scale (VAS) of Patient Controlled Analgesia (PCA) doses delivered, and PCA doses demanded by the patients. This method is for testing the differences between means of independent samples. In this case, using SPSS and Student-Newman-Keuls (SNK) and Tukey post-hoc analysis performed a One-way ANOVA. F-tests were also carried out to determine significance between means of the variables, time of first ambulation, bowel movement, total PCA demand and total PCA doses. Statistical significance is based on P value with P < 0.05; clinical beneficial is based on P < 0.10. The results indicated that the means and standard deviations of the four groups were within a close range. Forty-seven women who had hysterectomies met the criteria. The women were randomly allocated to four different groups. Except for those in the control group, treatment was given by an acupuncturist preoperatively and consisted of a course of either sham, low or high frequency stimulation. All groups were assessed during the postoperative period for 24 hours. The Visual Analogue Scale (VAS) was used to determine the amount of perceived pain felt by each subject. It was a 0-10 scale with 0 being no pain and 10 being most severe pain. The data was collected over a 24-hour period commencing post operatively. The significant differences between the groups at each specific time interval were examined. Results showed a clearly decreasing trend in the amount of pain felt over the 24-hour period for all the four groups with respect to the PCA and time. Significant differences or clinical benefits were found between the means at two hours post-operatively with F(3,42) = 2.66 at p<0.10; three hours post-operatively, F(3,42) = 3.68; p<0.05, four hours post-operatively, F(3,42) = 4.33, p<0.05; eight hours post-op, F(3,42) = 3.33, p<0.05; sixteen hours post-op, F(3,42) = 4.25, p<0.05; and twenty-four hours, F(3,42) = 4.67, p<0.01. Further post-hoc analysis showed that at one hour post-operatively, groups one and four were different to each other at the p<0.10 level. At three hours, group 1 (M=6.05) was significantly higher, at the p<0.05 level, than group 4 (M=3.00). This difference was also found at four hours, group 1 (M=5.65) and group four (M=2.71); eight hours, group 1 (M=4.808) and group four (M=2.57); sixteen hours, group 1 (M=4.46) and group 4 (M=2.0); and twenty - four hours, group1 (M= 3.50) and group 4 (M=1.21). Both post-hoc comparison tests indicate that group 4 was significantly different from groups 1, 2, and 3 at twenty-four hours. Differences between the means (M) over the four time intervals for Patient Controlled Analgesia (PCA) doses requirement were also examined. Significant differences were found with F(3,43) = 3.69 at p<0.05, in the Post Operative Room (POR) between the groups. Post-hoc analysis confirmed that group 4 (M=2.30) was significantly lower than groups 2 (M=5.17), and 3 (M=4.58). Post-hoc comparison tests indicate that mean PCA doses in the POR, for group 4 was significantly different from group 2 and 3. Mean PCA doses between groups 1 and 4 have no differences. Differences between the groups between one and eight hours post-operatively were also found with F(3,43)=2.33 at p<0.10. However, post-hoc analysis did not confirm this finding between any of the four groups. To compare the mean amount of Patient Controlled Analgesia (PCA) demands of the four groups over the 24 hours post-operative, a one-way ANOVA with S.N.K and Tukey-HSD post-hoc tests were applied. The results showed that the four groups had a similar trend within 24 hours postoperatively. However, significant differences were found between the means at the Post Operating room with F(3,43) = 4.80 at p<0.01, and 1 to 8 hours postoperative with F(3,43) = 3.49 at p<0.05. Post-hoc analysis confirmed the significant difference between the means at 1 to 8 hours postoperative as group 2 (M=55.75) was significantly higher than group 4 (M=22.30). Post-hoc analysis also confirmed that group 2 (M=30.83) was significantly higher than group 3 (M=13.00) and group 4 (M=5.90) at the POR. No other significance was found between means. The results of PCA doses demanded by subjects indicated that there was no significant difference between the total PCA doses given for the four groups over twenty-four hour period post-operatively. However, a one way ANOVA was applied to compare the groups for total PCA doses demanded and significant differences were found between the groups with F(3,42) = 3.59 at p<0.05. Post-hoc analysis confirmed the difference between groups 1 (M=84.54) and 4 (M=41.60). Moreover, differences were found between the four groups for the amount of analgesia delivered in mg, F(3,43)=2.45, p<0.10. Post-hoc analysis confirmed this finding between group one (M=38.63) and four (M=29.29). The thesis concludes with a discussion of methodological issues related to conducting randomized, placebo-controlled trials of electro-acupuncture and goals for future research in this area of pain management. Treatment outcome of SSP needless electro-acupuncture showed an improvement of the time of first bowel movement and ambulation, opioid related side effects, total amount of PCA demand, and total amount of PCA doses. The clinical significance of this particular study is of great interest, especially for those patients who wish for a non-pharmacological analgesia without side effects. Although further study is needed to ultimately determine whether SSP needle-free electro-acupuncture (EA) has a place in postoperative pain treatment, this study has suggested that SSP needle-free EA does have a place as an adjunct to standard medical care for post-operative surgical pain. Arguably this ‘needle free approach’ has benefits for patients who have difficulties with traditional acupuncture needling and at the same time are interested in a non-pharmacological approach to treating pain.

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