記住我
Silver needles are made of 80% silver and other metals, and they are divided into a needle body and a needle handle. In the clinic, silver needle therapy (SNT) is similar to moxibustion but has a difference. Moxibustion involves heating by burning alcohol cotton, which cannot control the temperature accurately.[1] The SNT is heated by a piece of equipment; therefore, the temperature can be adjusted based on the patients’ feedback and provide a reliable constant temperature.[2] SNT alleviates pain through 3 mechanisms: elimination of sterile inflammation, improvement of blood circulation, and relief of muscle spasms.[2] During the treatment, a silver needle is inserted at the tenderness points, usually the muscle attachment point, the muscle bundle, fascia or tendon. Therefore, many beginners and junior physician (JP) can quickly master the essentials of SNT and perform it skillfully.
Low back fasciitis is a growing problem worldwide that affects the quality of life of 30% of the population[3] and may lead to lifelong inconvenience, poor sleep, and psychological problems.[4] Low back pain induced by fasciitis is a very common symptom that occurs in all age groups and countries.[5]Low back fasciitis occurs in both urban and rural populations. SNT has been applied for fasciitis and has shown good therapeutic effects.[6] An increasing number of physicians use SNT to treat low back fasciitis in East Asia.
Generally, senior physician (SP) will achieve better medical effects and perform more skillful operations. However, SNT is a relatively simple treatment technique, and the operation can generally be carried out after skillfully after 7 to 10 days of training. However, no study has examined whether the efficacy of SNT is affected by physicians’ seniority. Therefore, this study aimed to observe the influence of physicians’ seniority on the efficacy of SNT through a single-center, prospective, cohort study.
2. Patients and materials 2.1. Ethical considerationsThis study was approved by the Medical Ethics Committee of the Affiliated Hospital of Qingdao University before the recruitment period started. This study was registered in the Chinese Clinical Trial Registry, and the registration number was ChiCTR1800018385. Written informed consent was provided by each patient during the initial assessment. A flow diagram throughout the study is presented in Figure 1.
Figure 1.: Flow chart of the study.
2.2. Study design and populationThis study was a single-center, prospective, cohort study that was carried out at the Affiliated Hospital of Qingdao University. From September 2018 to August 2019, patients who were diagnosed with low back fasciitis and hospitalized in the Department of Pain Management were recruited for this study.
The inclusion criteria were as follows: low back fasciitis (diagnosis: low back pain, hyperintensities of the fascia shown by magnetic resonance imaging, and organic disease excluded); age from 20 to 70 years old; and provision of signed informed consent. The exclusion criteria were as follows: communication disorders; coagulation abnormality; local or systemic infection; mental illness caused by pain; allergy to anesthetics; secondary pain including cancer pain, ankylosing spondylitis, postherpetic neuralgia, etc; and pregnancy.
2.3. SNT techniqueThe SNT technique was performed as previously described.[7] Generally, in a prone position, the patients were identified at points of tenderness, which were usually locations including but not limited to the interspinous space, paravertebral region, and upper edge of the iliac crest. After sterilization, 0.5% lidocaine was injected intradermally, and silver needles were inserted perpendicularly or obliquely to the targeted points 1 to 1.5 cm apart, which eventually covered the pain area. Then, the silver needles were heated to 42°C for 25 minutes through a special machine (Fig. 2).
Figure 2.: Silver needle therapy. (A) The silver needles were punctured into the paravertebral space in the area of the pain and then, the silver needles were connected to a special machine and heated. (B) After the therapy finished, blushing of the skin occurred.
2.4. Data preparation and clinical measurementsWe split the population into a JP group and a SP group. In the JP group, the SNT was performed by Chao Meng or Xing Wu (engaged in SNT for 3–5 years, and the number of operations was 1000–1300). In the SP group, SNT was performed by Yanwei Yin or Junmin Yu (engaged in SNT for more than 10 years, and the number of operations exceeded 5000).
The demographic data of all patients were recorded. The primary outcome was the 10-point numerical rating scale (NRS) during the SNT and the NRS at 1, 2, 6, and 12 months after the treatment. The secondary outcomes were the operation time and the Oswestry Disability Index (ODI) and the Short-Form 12 of quality of life (SF-12) at 1, 2, 6, and 12 months after the treatment. The heart rate variability (HRV) (ZSY-1 Heart Rate Variation Detector, Wegene Technology Inc., Shenyang, China),[8] including the natural logarithm of the low frequency measurement (InLF), the natural logarithm of the high frequency measurement (InHF), and the low frequency/high frequency ratio (LF/HF) were also assessed before the treatment and 1, 6, and 12 months after the treatment. Additionally, the complications reported by the patients up to 2 months after the treatment were recorded.
According to the NRS score during the SNT in the pilot trial, a sample size of 30 patients per group was required to obtain 80% power to detect differences at an α level of 0.05, indicating significance. The sample size accounted for a potential 25% rate of loss to follow-up.
2.5. Statistical analysisBased on parametric test results, the baseline characteristics of the patients were presented as the mean values with standard deviation (continuous variables) or absolute and relative frequencies (categorical variables). Qualitative variables were compared using the chi-squared test or Fisher exact test when appropriate, and quantitative variables were compared using the nonparametric Mann-Whitney U-tests. P < .05 was considered statistically significant. Univariate analysis was carried out to observe the effect of physicians’ seniority on outcomes after SNT. The NRS score during the SNT and the operation time showed significant differences in univariate analysis. Multiple linear regression was then performed to identify the independent predictors of the NRS score during the SNT and the operation time. SPSS 20.0 was used to perform statistical analysis.
3. ResultsA total of 60 patients were eventually enrolled in this study (Fig. 1). These patients were mainly middle-aged (47.3 ± 13.6 years old) and the ratio of males to females was appropriate (28:32). Before admission, the NRS, ODI, and SF-12 scores of these patients were 7.10 ± 0.84, 64.8 ± 2.6, and 19.5 ± 2.6, respectively; the scores were 3.53 ± 0.93, 39.5 ± 3.4, and 53.3 ± 11.5 at 1 month after discharge, respectively, and 1.82 ± 0.68, 24.8 ± 2.7, and 70.3 ± 3.6 at 12 months after discharge, respectively. The InLF and InHF were increased after treatment at 1, 6, and 12 months after discharge, and they showed no differences at 1, 6, and 12 months after discharge. The LF/HF also had no differences between before admission and after discharge. Additionally, 5 patients experienced complications (Table 1).
Table 1 - Demographic and clinical characteristics of all patients undergoing silver needle therapy (frequency or means ± SD). Age (yr) 47.3 ± 13.6 Sex (male/female) 28/32 BMI (kg/m2) 24.6 ± 2.7 ASA grade I–II 54 III 6 NRS before admission 7.10 ± 0.84 ODI before admission 64.8 ± 2.6 SF-12 before admission 19.5 ± 2.6 InLF before admission 3.96 ± 0.63 InHF before admission 3.37 ± 0.57 LF/HF before admission 1.82 ± 0.27 Duration of pain (mo) 3.9 ± 0.8 NRS during the SNT 3.9 ± 1.6 Operation time (min) 9.2 ± 2.8 Total hospital day 5.1 ± 0.9 NRS after discharge 1 mo 3.53 ± 0.93 NRS after discharge 2 mo 2.48 ± 0.87 NRS after discharge 6 mo 2.07 ± 0.73 NRS after discharge 12 mo 1.82 ± 0.68 ODI after discharge 1 mo 39.5 ± 3.4 ODI after discharge 2 mo 25.4 ± 2.4 ODI after discharge 6 mo 24.5 ± 2.0 ODI after discharge 12 mo 24.8 ± 2.7 SF-12 after discharge 1 mo 53.3 ± 11.5 SF-12 after discharge 2 mo 70.3 ± 4.9 SF-12 after discharge 6 mo 70.0 ± 2.9 SF-12 after discharge 12 mo 70.3 ± 3.6 InLF after discharge 1 mo 4.87 ± 0.59 InLF after discharge 6 mo 4.80 ± 0.57 InLF after discharge 12 mo 4.75 ± 0.52 InHF after discharge 1 mo 4.24 ± 0.57 InHF after discharge 6 mo 4.20 ± 0.53 InHF after discharge 12 mo 4.14 ± 0.47 LF/HF after discharge 1 mo 1.90 ± 0.22 LF/HF after discharge 6 mo 1.85 ± 0.29 LF/HF after discharge 12 mo 1.87 ± 0.36 Complications 5ASA = American Society of Anesthesiologists, BMI = body mass index, InHF = natural logarithm of high frequency measurement, InLF = natural logarithm of low frequency measurement, LF/HF = low frequency/high frequency ratio, NRS = numerical rating scale, ODI = oswestry disability index, SF-12 = short-form 12 of quality of life, SNT = silver needle therapy.
Of the 60 patients, 30 patients (50%) received SNT through JP, and 30 patients (50%) received SNT through SP. Compared with the JP group, the age, sex, BMI, ASA grade, NRS score before admission, ODI score before admission, SF-12 before admission and duration of pain of patients in the SP group were not significantly different (Table 2). However, comparative analysis showed significant differences in NRS score during the SNT and operation time between patients in the JP and SP groups (P < .001). Additionally, the total hospital stay, NRS score after discharge, ODI score after discharge, SF-12 score after discharge, and rate of complications were not significantly different between the JP and SP groups (Table 3).
Table 2 - Baseline characteristics and outcomes in the JP and SP cohorts (n = 30; frequency or means ± SD). JP group SP group t/χ2 P Age (yr) 50.2 ± 14.3 44.4 ± 12.5 1.664 .101 Sex (male/female) 15/15 13/17 0.268 .605 BMI (kg/m2) 24.2 ± 2.4 25.1 ± 3.0 −1.289 .203 ASA grade 0.185 .667 I–II 26 28 III 4 2 NRS before admission 7.13 ± 0.90 7.07 ± 0.78 0.306 .761 ODI before admission 64.2 ± 2.4 65.4 ± 2.7 −1.780 .080 SF-12 before admission 19.7 ± 2.3 19.2 ± 3.0 0.845 .402 InLF before admission 3.97 ± 0.60 3.94 ± 0.66 0.163 .871 InHF before admission 3.41 ± 0.51 3.32 ± 0.64 0.604 .548 LF/HF 1.77 ± 0.28 1.87 ± 0.24 −1.561 .124 Duration of pain (mo) 3.9 ± 0.8 3.8 ± 0.8 0.474 .638ASA = American Society of Anesthesiologists, BMI = body mass index, InHF = natural logarithm of high frequency measurement, InLF = natural logarithm of low frequency measurement, JP = junior physician, LF/HF = low frequency/high frequency ratio, NRS = numerical rating scale, ODI = oswestry disability index, SF-12 = short-form 12 of quality of life, SP = senior physician.
JP = junior physician, NRS = numerical rating scale, ODI = oswestry disability index, SF-12 = short-form 12 of quality of life, SP = senior physician.
Compared with the JP group, the InLF, InHF, and LF/HF before admission in the SP group were not significantly different (Table 2). Furthermore, at 1, 6, and 12 months after discharge, the InLF, InHF, and LF/HF were not significantly different between the JP group and SP group (Table 4).
Table 4 - HRV outcomes in the JP and SP cohorts (n = 30; frequency or means ± SD). JP group SP group t P InLF after discharge 1 mo 4.98 ± 0.55 4.77 ± 0.61 1.420 .161 6 mo 4.84 ± 0.46 4.77 ± 0.67 0.499 .620 12 mo 4.75 ± 0.45 4.74 ± 0.58 0.060 .953 InHF after discharge 1 mo 4.33 ± 0.54 4.14 ± 0.59 1.291 .202 6 mo 4.23 ± 0.46 4.17 ± 0.61 0.424 .673 12 mo 4.15 ± 0.41 4.13 ± 0.52 0.162 .872 LF/HF after discharge 1 mo 1.92 ± 0.20 1.88 ± 0.23 0.767 .446 6 mo 1.86 ± 0.22 1.85 ± 0.35 0.122 .903 12 mo 1.86 ± 0.35 1.88 ± 0.37 −0.252 .802HRV = heart rate variability, InHF = natural logarithm of high frequency measurement, InLF = natural logarithm of low frequency measurement, JP = junior physician, LF/HF = low frequency/high frequency ratio, SP = senior physician.
Due to the significant differences in the NRS score during the SNT and operation time between the JP and SP groups, multivariate linear regression analysis was used to confirm the variables affecting the NRS score during the SNT and operation time. The SP group showed a significantly lower NRS score during the SNT (B = −2.621, 95% CI: −3.106 to −2.137; P < .001) and a significantly lower operation time (B = −4.734, 95% CI: −5.515 to −3.954; P < .001). In contrast, the NRS score during the SNT and operation time was not associated with other outcome variables, such as sex, age, BMI, ASA grade, duration of pain, NRS score before admission, ODI score before admission, and SF-12 score before admission (Table 5).
Table 5 - Multivariate linear regression analysis of variables affecting NRS during the SNT and operation time. NRS during the SNT (B (95% CI)) Operation time (B (95% CI)) Female sex −0.106 (−0.621 to 0.408); P = .679 −0.289 (−1.118 to 0.540); P = .487 Age 0.110 (−0.008 to 0.031); P = .253 −0.004 (−0.035 to 0.028); P = .819 BMI −0.310 (−0.123 to 0.061); P = .501 0.068 (−0.081 to 0.216); P = .364 Duration of pain −0.113 (−0.415 to 0.189); P = .456 0.217 (−0.270 to 0.704); P = .375 ASA grade (III) −0.571 (−1.403 to 0.260); P = .174 0.373 (−0.967 to 1.713); P = .579 NRS before admission 0.20 (−0.272 to 0.313); P = .889 0.217 (−0.253 to 0.688); P = .358 ODI before admission −0.019 (−0.122 to 0.083); P = .707 −0.067 (−0.233 to 0.098); P = .413 SF-12 before admission −0.052 (−0.145 to 0.042); P = .273 0.094 (−0.057 to 0.244); P = .216 Senior physician −2.621 (−3.106 to −2.137); P < .001 −4.734 (−5.515 to −3.954); P < .001ASA = American Society of Anesthesiologists, BMI = body mass index, NRS = numerical rating scale, ODI = oswestry disability index, SF-12 = short-form 12 of quality of life, SNT = silver needle therapy.
As a traditional treatment, SNT has many advantages. First, SNT does not have side effects like drugs, and it can be performed multiple times. Currently, aseptic inflammatory tissue can be damaged through SNT, and new microcirculation will be reestablished.[7] This period is approximately 1 to 2 months. Because the tissues need 1 to 2 months to recuperate after SNT, 1 part of the body can only be treated once in 1 to 2 months in the clinic. Second, SNT is easy to operate and master, which is helpful in clinical applications. Finally, SNT decreased pain mainly through 3 mechanisms: elimination of sterile inflammation, improvement in blood circulation, and relief of muscle spasms, which was more suitable for elderly patients with poor basic conditions.
Currently, there are many methods for the treatment of low back fasciitis, including but not limited to physical therapy,[9] pulsed electromagnetic field therapy,[10] opioid therapy,[11] and nonsteroidal anti-inflammatory drugs.[12] However, these methods still cannot achieve good effects. SNT is widely used in soft tissue pain and is one of the essential techniques of the Pain Department. Therefore, many young physicians need to learn SNT. In addition to the treatment of low back fasciitis, almost all medical techniques, patients in China, who think the therapeutic effect of SPs is better, are more inclined to choose SPs. However, for the SNT, the therapeutic effect truly differs between JP and SP, which is the aim of this study.
In the present cohort study, it was indicated that SNT decreased the NRS and ODI and increased the SF-12 score at 1 month after treatment, and the efficacy could be maintained for 12 months. In addition, there were 5 patients with complications: 3 with ecchymosis and 2 with ambustion. We also found that JP increased the NRS score during the SNT and operation time, but the hospital stay, NRS, ODI, SF-12 score, and complications were not affected. The analysis herein revealed that the physicians’ seniority was an independent factor affecting the NRS score during the SNT and operation time.
HRV is an index used to assess autonomic nervous system (ANS) activity, InLF indicates ANS function, InHF indicates parasympathetic nerve function, and LF/HF indicates sympathetic nerve function.[8] In this study, ANS activity was improved by SNT mainly via the parasympathetic nervous system at 1, 6, and 12 months after discharge, which was demonstrated by the increased InLF and InHF, and no significant changes in LF/HF were observed. We also found that the physicians’ seniority did not affect ANS activity. Currently, ANS activity is considered important in pain.[13] Previous studies showed similar results. Karri et al found that LF and HF decreased with no change in LF/HF in patients with chronic neuropathic pain induced by spinal cord injury.[14] Hsu et al also showed that the sympathetic nervous system was also involved in the pain of patients after total knee replacement.[15] Therefore, we think the parasympathetic nervous system plays an important role in chronic pain. In other words, sympathetic nerve activity can be adjusted during the duration of pain. Therefore, in addition to pain and function, SNT also improved the ANS activity of patients with low back fasciitis, especially the parasympathetic nervous system, which was not influenced by the physicians’ seniority.
According to the results of this study, the main differences between JP and SP were the NRS score during the SNT and operation time. There were multiple potential explanations for these findings. First, the experience and proficiency of JP were not as good as SP, which was closely related to the short working time. Second, JP may take considerable time in the positioning process because of the incomplete control of local anatomy, which would be improved over time, and this does not affect the therapeutic effects.
There are many studies about the effects of physicians’ seniority. However, this study was the first to observe the influence of physicians’ seniority on the efficacy of SNT. In 2016, Li et al found that the senior emergency physicians decreased mortality and increased the length of hospital stay for patients in the emergency department.[16] In 2018, Wang et al thought that surgeons with rich experience reduced the chance of a second craniotomy and increased the chance of a good prognosis for the patients with neurosurgery.[17] In 2020, Tsai et al found that junior emergency physicians needed more CT examinations for patients with isolated vertigo/dizziness but had a shorter hospital stay.[18] Mujagic et al showed that having a JP did not have an effect on the surgical site infection rate for orthopedic trauma and vascular surgery.[19] Therefore, some aspects of medical outcomes were influenced by the physicians’ seniority, while some were not. Similar results were observed in this study. The physicians’ seniority affected the NRS score during the SNT and operation time, while the efficacy of SNT (NRS, ODI, SF-12, and HRV after treatment) was not influenced.
Every year, a large number of medical students graduate and work in hospitals. Additionally, many elderly physicians retire. Therefore, training young physicians is not only the responsibility of the department but also the source of the development and progress of the hospital. During this process, many problems will inevitably be encountered, including surgical results, patient satisfaction, and medical accidents, which may limit the training of young physicians. Through this study, we found that the JP could guarantee the efficacy of SNT. Therefore, SNT deserves wider application and safe operation by young doctors.
In this study, we found that almost half of the people were lost in the 2 groups. These patients were all unable to accept complicated forms and long telephone inquiries when the study began, even though they had already provided the informed consent form. The other patients all finished the study. Therefore, to some extent, the results of this study have not been affected by the lost patients. Additionally, 5 (8.3%) patients experienced complications after SNT: 3 in the JP group (2 with ecchymosis and 1 with ambustion) and 2 in the SP group (2 with ecchymosis). Ecchymosis may be related to the abundant blood supply in the subcutaneous tissue, which may be absorbed in a few days. For ambustion, it may be related to the tilt of the needle body and its close proximity to the skin. This complication can be avoided by careful inspection, better fixation of the body of the needle, or placing gauze padding between the skin and the oblique needle.
This study has several limitations. First, the relatively small sample size in a single center may decrease the persuasiveness of this study and may not necessarily by generalizable to other centers. Second, physicians with different academic qualifications or hospitals in urban or rural locations may affect the results of this study. Then, the small number of treating physicians (4) was included in this study, which may raise concerns for the statistical power or results regarding the seniority topic. We will expand the number of physicians in future study. Finally, the follow-up time was only 12 months, and a longer time might reveal more benefits or drawbacks.
In conclusion, our results suggested that SNT could attenuate the pain of patients with low back fasciitis in the short and long term. JP did not influence the efficacy of SNT but increased the operation time and the degree of pain during the operation. Therefore, the use of SNT should be promoted in the clinic and performed by JP.
Author contributionsConceptualization: Xiaojun Tian, Bing Zhang, Xuan Wang, Chao Meng.
Data curation: Bing Zhang, Xuan Wang.
Formal analysis: Chao Meng.
Investigation:
留言 (0)