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Evaluating the analgesic effect and advantage of transcutaneous electrical acupoint stimulation combined with opioid drugs for moderate to severe cancer-related pain: a study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Transcutaneous electrical acupoint stimulation (TEAS), which is also known as acupuncture-like transcutaneous electrical nerve stimulation (TENS), has been widely used in acute or chronic pain. However, previous research has not demonstrated that TEAS is effective for cancer-related pain. Opioid drugs are strongly recommended for treating cancer-related pain, but opioid-induced immunosuppression is still the most intractable drug-induced medical problem. Evaluating the efficacy and potential advantage of TEAS combined with opioid drugs in moderate and severe cancer-related pain in China is important because such studies are lacking. METHODS/DESIGN:This trial is a multicenter, prospective randomized controlled clinical trial. In total, 160 patients who were enrolled from two hospitals in the Zhejiang Province (China) will be randomly allocated into two groups: a TEAS group and sham TEAS group without acupoint electrical stimulation. Both groups will receive a 21-day interval of chemotherapy and conventional cancer pain therapy. Fifteen treatment sessions will be performed over a three-week period. The primary outcomes will be measured by changes in the Numerical Rating Scale (NRS) scores and equivalent dosage of morphine at baseline, three weeks of treatment and one two-week follow-up. The secondary outcome measures include cellular immunity function, life quality assessment, opioids side effects assessment, and safety and compliance evaluation. DISCUSSION:This trial is expected to clarify whether TEAS is effective for cancer-related pain. These results demonstrate the advantage of TEAS combined with opioid drugs on improving immune function and decreasing opioid induced side effects. TRIAL REGISTRATION:Chinese Clinical Trial Registry, ChiCTR-13003803 . Registered on 27 August 2013.

SUBMITTER: Liang Y

PROVIDER: S-EPMC6329064 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Evaluating the analgesic effect and advantage of transcutaneous electrical acupoint stimulation combined with opioid drugs for moderate to severe cancer-related pain: a study protocol for a randomized controlled trial.

Liang Yi Y Bao Guanai G Gong Liyan L Zhou Jie J Kong Xiangming X Ran Ran R Shao Xiaomei X Jiang Yongliang Y Zhang Weiping W Liu Boyi B Du Junying J Fang Junfan J Nie Na N Ji Conghua C Fang Jianqiao J

Trials 20190111 1

<h4>Background</h4>Transcutaneous electrical acupoint stimulation (TEAS), which is also known as acupuncture-like transcutaneous electrical nerve stimulation (TENS), has been widely used in acute or chronic pain. However, previous research has not demonstrated that TEAS is effective for cancer-related pain. Opioid drugs are strongly recommended for treating cancer-related pain, but opioid-induced immunosuppression is still the most intractable drug-induced medical problem. Evaluating the efficac ...[more]

PMID: 30635007

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Project description:BackgroundLumbar disc herniation is seen in 5-15% of patients with lumbar back pain and is the most common spine disorder demanding surgical correction. Spinal surgery is one of the most effective management for these patients. However, current surgical techniques still present complications such as chronic pain in 10-40% of all patients who underwent lumbar surgery, which has a significant impact on patients' quality of life. Research studies have shown that transcutaneous electrical acupoint stimulation (TEAS) may reduce the cumulative dosage of intraoperative anesthetics as well as postoperative pain medications in these patients.ObjectiveTo investigate the effect of pTEAS on pain management and clinical outcome in major spinal surgery patients.MethodsWe conducted a prospective, randomized, double-blind study to verify the effect of pTEAS in improving pain management and clinical outcome after major spinal surgery. Patients (n = 90) who underwent posterior lumbar fusion surgery were randomized into two groups: pTEAS, (n = 45) and Control (n = 45). The pTEAS group received stimulation on acupoints Zusanli (ST.36), Sanyinjiao (SP.6), Taichong (LR.3), and Neiguan (PC.6). The Control group received the same electrode placement but with no electrical output. Postoperative pain scores, intraoperative outcome, perioperative hemodynamics, postoperative nausea and vomiting (PONV), and dizziness were recorded.ResultsIntraoperative outcomes of pTEAS group compared with Control: consumption of remifentanil was significantly lower (P < 0.05); heart rate was significantly lower at the end of the operation and after tracheal extubation (P < 0.05); and there was lesser blood loss (P < 0.05). Postoperative outcomes: lower pain visual analogue scale (VAS) score during the first two days after surgery (P < 0.05); and a significantly lower rate of PONV (on postoperative Day-5) and dizziness (on postoperative Day-1 and Day-5) (P < 0.05).ConclusionpTEAS could manage pain effectively and improve clinical outcomes. It could be used as a complementary technique for short-term pain management, especially in patients undergoing major surgeries.Trial registrationChiCTR1800014634, retrospectively registered on 25/01/2018. http://medresman.org/uc/projectsh/projectedit.aspx?proj=183.

Project description:Laparoscopy is performed worldwide due to its limited side effects and optimal treatment efficacy. However, it also has adverse effects, including atelectasis and ischemia-reperfusion injury, due to CO2 accumulation during ventilation in a head-down position, which may result in severe disorders and adversely affecting postoperative recovery, prolonging hospitalization. The present study was performed to assess whether transcutaneous electrical acupoint stimulation (TEAS) protects against lung injury occurring during gynecological laparoscopic surgery. Patients were randomly allocated to two groups: Control group (received no stimulation) and TEAS group (patients treated with TEAS on BL13, LI4 and LU5). The mean arterial pressure, heart rate and oxygen saturation were recorded at the time-points of arriving in the operating room (T0), immediately prior to induction of the pneumoperitoneum (T1), immediately after the end of pneumoperitoneum (T2) and on leaving the operating room (T3). Arterial blood gas analysis was performed to record the pH, determine the partial pressure of carbon dioxide and calculate the oxygenation index (OI) at T0-3. Blood samples were taken from the peripheral vein for determination of the serum concentrations of tumor necrosis factor (TNF)-? and interleukin (IL)-1? at T0 and T3. Post-operative pulmonary complications occurring during the first five days after surgery were also recorded. A total of 100 patients were initially enrolled and 80 patients were analysed. The results indicated that the OI in the control group was significantly lower than that in the TEAS group at the T2 and T3 time-points. The serum concentrations of TNF-? and IL-1? were significantly increased following surgery, while the extent of these increases was lower in the TEAS group compared with that in the control group. The incidence of post-operative pulmonary complications was significantly lower in the TEAS group. It was therefore indicated that TEAS protect against lung injury as a complication of gynecological laparoscopic surgery. The present study was registered at http://www.clinicaltrials.gov prior to enrollment of the patients (no. NCT02850471).

Dataset Information

Evaluating the analgesic effect and advantage of transcutaneous electrical acupoint stimulation combined with opioid drugs for moderate to severe cancer-related pain: a study protocol for a randomized controlled trial.

Publications

Evaluating the analgesic effect and advantage of transcutaneous electrical acupoint stimulation combined with opioid drugs for moderate to severe cancer-related pain: a study protocol for a randomized controlled trial.

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