Effect of Baduanjin Qigong on Sleep Quality and Hyperarousal State in Adults With Chronic Insomnia: Protocol for a Randomized Controlled Trial.

BACKGROUND: Chronic insomnia (CI) is a mind-body disease that is commonly defined as a state of having disturbed daytime activities due to poor nighttime sleep quality. Baduanjin qigong (BDJQG) is widely used for CI in China. However, there is little scientific evidence to evaluate its effects on the hyperarousal state, which is closely associated with improved sleep quality. OBJECTIVE: The objective of the trial is to assess the therapeutic effects of BDJQG on sleep quality in patients with CI. METHODS: A randomized controlled trial will be conducted on 86 patients, who will be divided into a BDJQG group and a cognitive behavioral therapy for insomnia group at a ratio of 1:1. Interventions in both groups will be given to the participants 7 times a week for 8 weeks, and the participants will be followed up for 4 weeks. The primary outcome is the change in the Pittsburgh Sleep Quality Index from baseline to week 8. The secondary outcomes are the changes in the Hyperarousal Scale, Insomnia Severity Index, Fatigue Scale-14, wrist actigraphy, salivary cortisol level, and functional magnetic resonance imaging from baseline to week 8. All main analyses will be carried out on the basis of the intention-to-treat principle. RESULTS: This study was funded from January 2023. As of the submission of the manuscript, there were 86 participants. Data collection began in April 2023 and will end in January 2024. Data analysis is expected to begin in January 2024, with the publication of results expected in February 2024. CONCLUSIONS: This study will present data concerning the clinical effects of BDJQG on CI. The results will help to demonstrate whether BDJQG is an effective therapy for improving sleep quality in association with a decreased hyperarousal level as a possible underlying mechanism. This study will provide much-needed knowledge for complementary and alternative therapy for patients with CI. TRIAL REGISTRATION: China Clinical Registration Agency ChiCTR2300069241; https://chictr.org.cn/bin/project/ChiCTR2300069241. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/53501.

Effect of Tai Chi on knee pain and muscle strength in middle-aged and older adults with knee osteoarthritis: a randomized controlled trial protocol.

BACKGROUND: Knee osteoarthritis (KOA) is a common public health problem and a leading cause of long-term pain, decreased muscle strength, and even disability. Tai Chi has been proved effective and highly recommended for KOA management worldwide. However, little is known about its benefits on quadriceps strength which is closely associated with relieving knee pain. This trial is designed to evaluate the efficacy and safety of Tai Chi on knee pain and muscle strength in middle-aged and older adults with KOA. METHODS: A total of 100 participants will be randomly divided into a Tai Chi group (TC group) (1x/week for 12 weeks) and a control group with a health education and stretching program (1x/week for 12 weeks) with a follow-up period of 6 weeks. The primary outcome is the change of Western Ontario and McMaster Universities (WOMAC) pain subscale at week 12 compared with baseline. Secondary outcomes include WOMAC stiffness and function subscales, data from isokinetic dynamometry, gait analysis with electromyography (EMG), and a 36-item short form health survey (SF-36). The daily dose of pain-relieving medication will also be recorded. All adverse effects will be assessed by the Treatment Emergent Symptom Scale (TESS). DISCUSSION: We expect this randomized trial to evaluate the effectiveness of Tai Chi on relieving pain and increasing quadriceps strength in KOA patients. This protocol, if proven effective, will contribute to providing a promising alternative intervention for middle-aged and older adults with KOA. TRIALS REGISTRATION NUMBER: This trial has been registered in the China Clinical Trials Registry (registration number: ChiCTR2300069339).

Electroacupuncture for Pain Relief After Endoscopic Sinus Surgery: A Randomized Controlled Trial.

Postoperative pain is a common problem after endoscopic sinus surgery (ESS). Electroacupuncture (EA) is proven to be effective in relieving postoperative pain. However, EA has not been studied in patients undergoing ESS. This study was designed to evaluate the efficacy and safety of EA compared to a sham control in relieving pain after ESS. A total of 62 patients were randomly allocated to receive either EA (n = 31) or sham EA (n = 31) for 5 sessions, 30 minutes per session for 4 days (2 hours before and 2 hours after surgery, and 3 sessions daily for the following 3 days). There were no significant differences between the 2 groups with regard to demographic characteristics. Compared to the sham EA group, the EA group showed a significantly greater reduction in the pain intensity of single daily scoring with a numerical rating scale at the day following surgery (postoperative day 1, POD1) (-1.35; 95% confidence interval [CI], -1.74 to -0.97; P < .001) and POD2 (-1.16; 95% CI, -1.55 to -0.77; P < .001), whereas no significant between-group difference was detected at the day of surgery (POD0), POD3 or POD6. Intraoperative heart rate and mean blood pressure in the EA group showed a more stable trend. A significant improvement was found for an actigraphy-measured average time of night wakings, recovery time from anesthesia, and quality of recovery-15 in the EA group. No severe adverse events occurred during the trial. Our results demonstrate that EA can serve as an effective adjuvant therapeutic tool for pain relief after ESS. PERSPECTIVE: This randomized sham-controlled, patient-and-assessor blinded trial provided evidence for the first time that EA can relieve postoperative pain and other symptom management in patients after ESS. TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Registry, ChiCTR1900024183, http://www.chictr.org.cn/showproj.aspx?proj=40573.

Effect of electroacupuncture on discomfort during gastroscopy: A randomised controlled trial.

BACKGROUND: Gastrointestinal reactions, pain and discomfort are inevitable in patients undergoing common gastroscopy. Acupuncture is an effective therapy that assists in the perioperative period; however, evidence of it relieving discomfort is limited. We conducted this trial to observe the effect of electroacupuncture (EA) on discomfort caused by gastroscopy without sedatives. METHODS: This was a single-centre, patient-assessor blind, randomised controlled trial. Sixty patients requiring gastroscopy were randomly assigned to the EA and control groups (sham acupuncture, SA, group) in a 1:1 ratio. Patients in the EA group underwent treatment at acupoints LI4 (Hegu), PC6 (Neiguan), ST36 (Zusanli), and ST34 (Liangqiu) for 30 min before gastroscopy, whereas patients in the SA group underwent superficial acupuncture at non-acupoints. The patients' nausea level, throat discomfort, bucking, and agitation were evaluated using a visual analogue scale (VAS) within 30 min after gastroscopy. The mean VAS score was the primary outcome. Secondary outcomes were the Amsterdam Preoperative Anxiety and Information Inventory Scale, used to evaluate patients' preoperative anxiety levels, and the 6-item State-Trait Anxiety Inventory (STAI-S6), used to assess anxiety before and after gastroscopy. The patients' vital signs, including heart rate, blood pressure, and pulse oxygen saturation, were recorded before, during, and after gastroscopy. RESULTS: At 30 min after gastroscopy, the mean VAS score in the EA group (4.20 ± 0.63) was lower than that in the control group (5.14 ± 0.70, mean difference (MD): - 0.94, 95% confidence interval (CI): - 1.28, - 0.59, P < 0.001). There were statistically significant between-group differences in the nausea and vomiting, throat discomfort and agitation VAS scores (all P < 0.01), whereas no difference was found in the bucking VAS score (P = 0.692). Compared with the SA group, patients in the EA group had a 6.90-point lower in STAI-S6 (95% CI: -12.98, -0.81, P = 0.027) after gastroscopy. Patients in the EA group had a slower heart rate and lower blood pressure than those in the SA group. Serious adverse events were not observed during the trial. CONCLUSION: EA can help relieve patients' anxiety, and improve their nausea and vomiting, throat discomfort, and agitation during gastroscopy. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR) ID: ChiCTR2000040726.

[Jianpi Peiyuan acupoint thread embedding therapy for perimenopausal obesity: a randomized controlled trial].

OBJECTIVE: To observe the clinical efficacy and safety of Jianpi Peiyuan acupoint thread embedding therapy on perimenopausal obesity (PMO). METHODS: Ninety-six patients of PMO were randomly divided into an observation group (48 cases) and a control group (48 cases). The control group received health education and lifestyle intervention. On the basis of the treatment in the control group, the observation group was treated with acupoint thread embedding at the main acupoints of Shangwan (CV 13), Zhongwan (CV 12), Xiawan (CV 10), Yinlingquan (SP 9) and Fenglong (ST 40), etc. as well as the supplementary acupoints in accordance with the syndrome differentiation, once every 2 weeks for 8 weeks (4 times in total). The indexes of obesity (body mass index [BMI], waist circumference, hip circumference and body mass), modified Kupperman score, insomnia severity index (ISI) score, self-rating anxiety scale (SAS) score, and self-rating depression scale (SDS) score of the two groups were observed before and after treatment, and the safety was evaluated. RESULTS: After treatment, BMI, waist circumference, hip circumference and body mass in the two groups were lower than before treatment (P<0.05), and those in the observation group were lower than the control group (P<0.05). After treatment, Kupperman, ISI and SAS scores in the observation group were lower than before treatment (P<0.05), and ISI score in the control group was lower than before treatment (P<0.05). Kupperman, ISI and SAS scores in the observation group were lower than those in the control group (P<0.05). There was no significant difference in SDS between the two groups or within groups (P>0.05). No serious adverse reactions occurred during the experiment. CONCLUSION: Jianpi Peiyuan acupoint thread embedding therapy can reduce the degree of obesity in PMO patients, and improve patients' the perimenopausal symptoms, insomnia and anxiety, with good safety.

Effect of Electroacupuncture on Insomnia in Patients With Depression: A Randomized Clinical Trial.

Importance: Electroacupuncture (EA) is a widely recognized therapy for depression and sleep disorders in clinical practice, but its efficacy in the treatment of comorbid insomnia and depression remains uncertain. Objective: To assess the efficacy and safety of EA as an alternative therapy in improving sleep quality and mental state for patients with insomnia and depression. Design, Setting, and Participants: A 32-week patient- and assessor-blinded, randomized, sham-controlled clinical trial (8-week intervention plus 24-week observational follow-up) was conducted from September 1, 2016, to July 30, 2019, at 3 tertiary hospitals in Shanghai, China. Patients were randomized to receive EA treatment and standard care, sham acupuncture (SA) treatment and standard care, or standard care only as control. Patients were 18 to 70 years of age, had insomnia, and met the criteria for depression as classified in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition). Data were analyzed from May 4 to September 13, 2020. Interventions: All patients in the 3 groups were provided with standard care guided by psychiatrists. Patients in the EA and SA groups received real or sham acupuncture treatment, 3 sessions per week for 8 weeks, for a total of 24 sessions. Main Outcomes and Measures: The primary outcome was change in Pittsburgh Sleep Quality Index (PSQI) from baseline to week 8. Secondary outcomes included PSQI at 12, 20, and 32 weeks of follow-up; sleep parameters recorded in actigraphy; Insomnia Severity Index; 17-item Hamilton Depression Rating Scale score; and Self-rating Anxiety Scale score. Results: Among the 270 patients (194 women [71.9%] and 76 men [28.1%]; mean [SD] age, 50.3 [14.2] years) included in the intention-to-treat analysis, 247 (91.5%) completed all outcome measurements at week 32, and 23 (8.5%) dropped out of the trial. The mean difference in PSQI from baseline to week 8 within the EA group was -6.2 (95% CI, -6.9 to -5.6). At week 8, the difference in PSQI score was -3.6 (95% CI, -4.4 to -2.8; P < .001) between the EA and SA groups and -5.1 (95% CI, -6.0 to -4.2; P < .001) between the EA and control groups. The efficacy of EA in treating insomnia was sustained during the 24-week postintervention follow-up. Significant improvement in the 17-item Hamilton Depression Rating Scale (-10.7 [95% CI, -11.8 to -9.7]), Insomnia Severity Index (-7.6 [95% CI, -8.5 to -6.7]), and Self-rating Anxiety Scale (-2.9 [95% CI, -4.1 to -1.7]) scores and the total sleep time recorded in the actigraphy (29.1 [95% CI, 21.5-36.7] minutes) was observed in the EA group during the 8-week intervention period (P < .001 for all). No between-group differences were found in the frequency of sleep awakenings. No serious adverse events were reported. Conclusions and Relevance: In this randomized clinical trial of EA treatment for insomnia in patients with depression, quality of sleep improved significantly in the EA group compared with the SA or control group at week 8 and was sustained at week 32. Trial Registration: ClinicalTrials.gov Identifier: NCT03122080.

Effect of electroacupuncture on discomfort during gastroscopy: a study protocol for a randomized controlled trial.

BACKGROUND: Gastroscopy procedures are frequently performed under general sedation to minimize discomfort. Patients who refuse a sedative injection may experience more discomfort and adverse reactions such as pain and nausea. These instances reduce patient compliance and willingness to participate in future procedures. Acupuncture has been shown to have an anti-nausea and analgesic effect; however, there is limited data available that demonstrates the efficacy of acupuncture when applied before gastroscopy. METHODS: A total of 60 participants will be randomly assigned to the electroacupuncture (EA) group and the sham electroacupuncture (SEA) group at a ratio of 1:1. Acupuncture treatment will be performed before gastroscopy for a duration of 30 min. All patients will complete detailed questionnaires at 30 min and 7 days post-procedure to record the severity of their symptoms. The primary outcome will be the average of 4 standard visual analogue scale (VAS) scores in the categories of nausea, vomiting, throat discomfort, and agitation as reported by the patient. The secondary outcomes will be patient's anxiety level as recorded by the 6-item short form of the State-Trait Anxiety Inventory (STAI-S6) and Amsterdam Pre-Operative Anxiety and Information Scale (APAIS), preference in a future endoscopy, pulse oxygen saturation (SpO2), heart rate (HR), and blood pressure (BP). Anxiety scales will be assessed before and after acupuncture; others will be completed at 30 min and 7 days post-procedure. The duration of the gastroscopy and the number of biopsies will be recorded after operation. DISCUSSION: This randomized controlled trial will explore the feasibility of the further clinical application of electroacupuncture for the improvement of patient discomfort during gastroscopy without systemic sedation. TRIAL REGISTRATION: ChiCTR2000040726 . This trial has been approved by the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine (2020SHL-KY-11). Registration date 12 August 2020.

Efficacy of electroacupuncture in patients with failed back surgery syndrome: study protocol for a randomized controlled trial.

BACKGROUND: Persistent pain following back surgery called failed back surgery syndrome remains a major treatment challenge. The aim of this study is to evaluate the efficacy and safety of electroacupuncture on relieving back pain in FBSS patients. METHODS/DESIGN: This is a randomized, single-blind, single-site, placebo-controlled trial. A total of 144 eligible FBSS patients will be randomly assigned to the electroacupuncture, manual acupuncture, or sham acupuncture group in a 1:1:1 ratio. Each group will receive 2 treatment sessions per week for 12 weeks. The primary outcome will be low back pain intensity based on the 11-point numerical rating scale (NRS). The secondary outcomes include Oswestry Disability Index (ODI) questionnaire, Beck Depression Inventory-II (BDI-II), Pittsburgh Sleep Quality Index (PSQI), and analgesic consumption. All clinical outcomes will be collected at baseline, during the treatment phase (at 8 and 12 weeks), and at the 16-, 24- and 36-week follow-ups. All data will be analyzed based on the intention-to-treat principle and adverse events will be assessed during the trial. DISCUSSION: This pilot randomized controlled trial will evaluate the efficacy of electroacupuncture for treating failed back surgery syndrome. The outcomes will determine whether electroacupuncture is efficacious in relieving low back pain as well as improving the quality of life in failed back surgery syndrome patients. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000040144 . Registered on 22 November 2020.

Electroacupuncture versus Sham Acupuncture for Perimenopausal Insomnia: A Randomized Controlled Clinical Trial.

OBJECTIVE: To evaluate the short- and long-term effects of acupuncture on perimenopausal insomnia (PMI) and quality of life. PATIENTS AND METHODS: We designed a semi-standardized, patient-blinded, randomized placebo-controlled trial. A total of 84 patients were recruited, all of whom met the criteria for diagnosis of PMI. Either acupuncture therapy or a noninvasive placebo acupuncture therapy designed to treat insomnia was implemented 18 times over the course of 8 weeks (3 times per week for 4 weeks, twice per week for 2 weeks, once per week for 2 weeks). The primary outcome was the change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to the end of treatment, week 8. Secondary outcomes included climacteric symptoms and quality of life measured by the Menopause Quality of Life (Men-QoL), Insomnia Severity Index (ISI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), sleep parameters recorded in the actigraphy and adverse events. The PSQI and Men-QoL were assessed at weeks 0, 4, 8, 12 and 20. Other assessments were performed at week 0 and week 8. RESULTS: The participants were randomly assigned to either acupuncture (n=42) or sham acupuncture (n=42) groups. The mean difference from baseline of PSQI score at the end of treatment between real acupuncture and sham acupuncture group was -2.38 (95% CI, -3.46 to -1.30; P<0.001). The acupuncture group was associated with significantly lower scores than the sham acupuncture group at week 12 and during the 20-week follow-up visits (all P <0.001). Acupuncture was also associated with significantly higher quality of life in vasomotor and other physical dimensions (all P <0.001). At the end of treatment, researchers found a significantly higher total sleep time (TST), sleep efficiency (SE) and lower number of average awakenings (AA) (P =0.007 0.023 and 0.011, respectively) in the acupuncture group than in the sham acupuncture group. No severe adverse events were reported. CONCLUSION: The findings suggest that acupuncture may be a safe and effective treatment for PMI and improving quality of sleep in patients with menopause and could have a long-lasting effect. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR); Trial ID: ChiCTR1800018645. URL: http://www.chictr.org.cn/showproj.aspx?proj=31482.

Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trial.

BACKGROUND: Cancer-related insomnia (CRI) is one of the most prevalent complaints among cancer survivors and severely impairs patients' quality of life. As a popular non-pharmacological alternative treatment, acupuncture provides a good clinical curative effect on insomnia. The aim of this trial is to evaluate efficacy and safety of electro-acupuncture on insomnia in patients with lung cancer. METHOD: This is a protocol for a multicenter randomized single-blinded sham-controlled trial. We will randomly assign 252 eligible patients with lung cancer-related insomnia into two groups at a ratio of 1:1, the treatment group (EA) and the control group (sham EA). All treatment will be given 3 times per week for 8 weeks, and a 12-week follow-up will be conducted. The primary outcome will be measured by the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will include sleep parameters recorded from the actigraphy, scores from Quality of Life Questionnaire Core-30 (QLQ-C30), and Patient Health Questionnaire-9 (PHQ-9). All adverse effects during the trial will be assessed by the Treatment Emergent Symptom Scale (TESS). All analyses will be based on ITT principle and performed with the statistical software SPSS (version 24.0) by t test, rank-sum test, chi-square, and so on. A two-sided significance level will be set at 5%. DISCUSSION: This large-sample trial protocol will evaluate the efficacy of electro-acupuncture on insomnia in patients with lung cancer. This protocol, if proven to be effective, will contribute to filling the gap in treatment options in the CRI field and provide a promising intervention for insomnia in lung cancer survivors. TRIAL REGISTRATION: ChiCTR ChiCTR1900026395. Registered on 8 October 2019, http://www.chictr.org.cn/showproj.aspx?proj=44068.

Electroacupuncture for postoperative pain after nasal endoscopic surgery: study protocol for a pilot randomized controlled trial.

BACKGROUND: Postoperative pain is common after nasal endoscopic surgery. It interferes with the quality of sleep and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied in a randomized controlled trial. METHODS/DESIGN: This randomized sham-controlled patient- and assessor-blind pilot trial has been designed to evaluate the efficacy and safety of electroacupuncture in managing postoperative pain following nasal endoscopic surgery to treat sinusitis due to nasal polyps. Altogether, 30 participants will be randomly allocated to an electroacupuncture or non-invasive sham control in a 1:1 ratio. Treatment will occur within 2 h before the operation, immediately after the operation upon arrival in the recovery ward, and once daily for 3 days. The primary outcome is the pain numerical rating scale, which will be analyzed using the area under the curve. The secondary outcome measures include heart rate and blood pressure after the operation, sleep quality during the hospital stay (actigraph), quality of recovery, and the 36-item short form health survey. This trial will use an intention-to-treat analysis. DISCUSSION: This pilot randomized controlled trial will explore the feasibility of the further clinical application of electroacupuncture for the management of postoperative pain. It will inform the design of a further full-scale trial. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR1900024183. Registered on 29 June 2019.