Efficacy of Acupuncture in Post-partum With Diastasis Recti Abdominis: A Randomized Controlled Clinical Trial Study Protocol

Background: Diastasis rectus abdominis (DRA) is one of the common complications during pregnancy and post-partum, which has psychological and physical effects on post-partum women. Acupuncture, a worldwide alternative therapy, has attracted wide attention in preventing and treating diseases related to pregnancy and childbirth. This study aims to evaluate the efficacy of acupuncture combined with physical training in treating post-partum rectus muscle dissociation.Methods: This is a randomized, controlled trial of DRA in post-partum conducted at Hangzhou Hospital of Traditional Chinese Medicine Affiliated with Zhejiang University of Chinese Medicine. The primary purpose is to evaluate the effectiveness of acupuncture and physical training on DRA in post-partum women. The study will be conducted from March 2022 to March 2023. The acupuncture group received acupuncture and physical training (n = 48), the sham acupuncture group received sham acupuncture and physical training (n = 48), and the physical training group received physical training (n = 48). These experiments perform once/day, five times a week for 2 weeks, followed up for half a year after the end of the course of treatment. Our tests perform a course of treatment, which includes a total of 10 consecutive treatments. Furthermore, the patient will be followed up for half a year after the treatment. Primary and secondary indicators, including inter recti distance (IRD), linea alba (LA) tension, the MOS item short-form health survey (SF-36), short-form McGill pain questionnaire-2 (SF-MPQ-2), body mass index (BMI), waist-to-hip ratio (WHR), leeds dyspepsia questionnaire (LDQ), menstrual distress questionnaire (MDQ), 10 items of edinburgh post-natal depression scale (EPDS-10), the modified body self-image scale (MBIS), international consultation incontinence questionnaire short-form (ICIQ-SF) and hernia-related quality-of-life survey (HerQles), which will be evaluated before and after treatment and half a year after treatment. Adverse events and side effects during each treatment will be collected and recorded.Discussion: There is evidence that acupuncture and physical training can treat DRA in post-partum. In this study, we evaluate the effectiveness of acupuncture in post-partum with DRA.

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Herbal medicine (Danggui-Shaoyao-San) and Ear Acupoint Pressing Beans in the treatment of dysmenorrhea caused by endometriosis and adenomyosis: a study protocol randomized controlled trial

10.21203/rs.2.9951/v1 ◽

2019 ◽

Author(s):

Yingzhou Tian ◽

Jiayi Wu ◽

Yanxiong Huang ◽

Xuefang Liang ◽

Lixing Cao

Keyword(s):

Clinical Trial ◽

Randomized Controlled Trial ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Short Form ◽

Controlled Trial ◽

International Standards ◽

Mcgill Pain Questionnaire ◽

Menstrual Pain ◽

Randomized Controlled

Abstract Endometriosis and adenomyosis are two of the most common causes of secondary dysmenorrhea and often lead to a deterioration in the quality of life. Traditional Chinese medicine and acupuncture are widely used in the treatment of menstrual pain in clinical practice. Danggui Shaoyao San (DSS) and ear acupoint pressing beans may constitute an effective treatment strategy for women with dysmenorrhea due to endometriosis and/or adenomyosis, although evidence is limited. Methods/design This randomized, controlled clinical trial aims to recruit patients who suffer from menstrual pain due to endometriosis and/or adenomyosis to evaluate the efficacy and safety of DSS and auriculotherapy. Primary outcome measures are Visual Analog Scale (VAS), Short-Form McGill Pain Questionnaire (SF-MPQ), dysmenorrhea symptoms and traditional Chinese medicine correlative time points. Discussion This pivotal trial will be a standardized, scientific, clinical trial designed to evaluate the use of DSS and auriculotherapy in the treatment of dysmenorrhea due to endometriosis and/or adenomyosis. The trial will also conform to the international standards of clinical trials for the recognition of traditional Chinese medicine. Trail registration Chinese Clinical Trail Registry, ID: ChiCTR-IOR-17013829 Registered on 11th December 2017 Keywords: Danggui Shaoyao San; Ear pressing beans; Endometriosis; Adenomyosis; Dysmenorrhea; Randomized controlled trial

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Effect of “Deqi” during the Study of Needling “Wang’s Jiaji” Acupoints Treating Spasticity after Stroke

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2014/715351 ◽

2014 ◽

Vol 2014 ◽

pp. 1-8 ◽

Cited By ~ 4

Author(s):

Huanqin Li ◽

Huilin Liu ◽

Cunzhi Liu ◽

Guangxia Shi ◽

Wei Zhou ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Statistical Difference ◽

Early Stage ◽

Controlled Trial ◽

Muscle Tension ◽

Sham Acupuncture ◽

Acupuncture Group ◽

Randomized Controlled ◽

Prospective Randomized Controlled Trial ◽

Sham Acupuncture Group

Background.Acupuncture has been shown to reduce spasticity and prevent the onset of spasticity after stroke. The purpose of this study is to assess the effect of “Deqi” during needling “Wang’s Jiaji” acupoints treating spasticity in the early stage of stroke.Methods. This study is a multicenter, prospective, randomized, controlled trial. 238 patients with stroke (<21 days) participated and were randomly allocated to the verum-acupuncture (n=121) group or sham-acupuncture group (n=117). The verum-acupuncture group received verum acupuncture required to produce the sense of “Deqi” while the sham-acupuncture group received sham acupuncture without “Deqi.” Patients in both groups followed the same 30 min acupuncture regimen 5 times per week for a period of 4 weeks. Scales of MAS, FMA, ADL, MBI, NIHSS, SS-QOL, and MRS were measured at baseline and at 2, 4, and 12 weeks after intervention.Results.Significant differences were observed between two groups. The MRS rating composition has the statistical difference after 4 weeks (P=0.017). The score of MAS, FMA, Barthel, and SSQOL in verum-acupuncture group has increased significantly compared with the sham-acupuncture group after 12 weeks. There was 14% reduction of higher muscle tension in the verum-acupuncture group.Conclusion.Acupuncture “Wang’s Jiaji” points with sensation of “Deqi” in the early stage may reduce the occurrence and decrease the severity of spasticity after stroke.

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The efficacy and safety of electro-acupuncture for alleviating chemotherapy-induced peripheral neuropathy in colorectal cancer patients: study protocol for a pilot single-blinded, randomized sham-controlled trial

10.21203/rs.2.11805/v2 ◽

2019 ◽

Author(s):

Kaiyin Chan ◽

Louisa Lui ◽

Kaling Yu ◽

Kwongwai Lau ◽

Manchi Lai ◽

...

Keyword(s):

Colorectal Cancer ◽

Hong Kong ◽

Peripheral Neuropathy ◽

Chinese Medicine ◽

Cancer Patients ◽

Controlled Trial ◽

Sham Acupuncture ◽

Acupuncture Group ◽

Efficacy And Safety ◽

Colorectal Cancer Patients

Abstract Background: Colorectal cancer is the most common cancer in Hong Kong. Oxaliplatin-based chemotherapy is a major first-line conventional therapy for advanced and metastatic colorectal cancer. However, oxaliplatin causes chemotherapy-induced peripheral neuropathy (CIPN). Acupuncture has long been used to alleviate limb numbness in Chinese Medicine Practice. This pilot study aims to examine the efficacy and safety of acupuncture for alleviating CIPN in colorectal cancer patients in Hong Kong. Methods/Design: This is a pilot single-blinded, randomized, sham-controlled trial. Eighty-four eligible patients, who are Hong Kong Chinese aged ≥18 years diagnosed with colorectal cancer and undergoing oxaliplatin-based chemotherapy, will be randomized in a ratio of 1:1 to electro-acupuncture group and sham-controlled group. During a 12-week treatment period, patients in electro-acupuncture group will undergo electro-acupuncture once a week from the first cycle of chemotherapy, patients in control group will receive sham-acupuncture, and the patients in both groups will be followed up for twelve weeks. The primary outcome measure is the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOC-Ntx) questionnaire. The secondary outcome measures include numerical rating scale (NRS) for numbness/pain, vibration and light touch sense test, quality of life questionnaire-C30 of European Organization for Research and Treatment of Cancer (EORTC QLQ-C30) and Constitution of Chinese Medicine Questionnaire (CCMQ). Discussion: The study will compare electro-acupuncture with sham acupuncture to explore the feasibility for electro-acupuncture in improving symptoms caused by chemotherapy-induced peripheral neuropathy.

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Central Sensitivity Is Associated with Poor Recovery of Pain: Prediction, Cluster, and Decision Tree Analyses

Pain Research and Management ◽

10.1155/2020/8844219 ◽

2020 ◽

Vol 2020 ◽

pp. 1-12

Author(s):

Hayato Shigetoh ◽

Masayuki Koga ◽

Yoichi Tanaka ◽

Shu Morioka

Keyword(s):

Cluster Analysis ◽

Decision Tree ◽

Pain Intensity ◽

Outcome Measures ◽

Short Form ◽

Depression Scale ◽

Hierarchical Cluster ◽

Mcgill Pain Questionnaire ◽

Decision Tree Analysis ◽

Tree Analysis

The process of pain recovery varies and can include the recovery, maintenance, or worsening of symptoms. Many cases of patients with pain show a tendency of recovering as predicted; however, some do not. The characteristics of cases that do not fit the prediction of pain recovery remain unclear. We performed cluster and decision tree analyses to reveal the characteristics in cases that do not fit the prediction of pain recovery. A total of 43 patients with musculoskeletal pain (nonoperative: 22 patients, operative: 13 patients) and central pain (brain disease: 5 patients, spinal cord disease: 3 patients) were included in this longitudinal study. Central sensitivity syndrome (CSS) outcome measures (Central Sensitisation Inventory), pain intensity-related outcome measures (Short-Form McGill Pain Questionnaire-2 (SFMPQ-2)), and cognitive-emotional outcome measures (Hospital Anxiety and Depression Scale and Pain Catastrophising Scale-4) of all patients were assessed at baseline and after 1-2 months. Regression analysis was used to calculate pain recovery prediction values. A hierarchical cluster analysis based on the predicted change of SFMPQ-2 and the observed change of SFMPQ-2 was used to extract subgroups that fit and those that do not fit pain recovery prediction. To extract the characteristics of subgroups that do not fit the prediction of pain recovery, a decision tree analysis was performed. The level of significance was set at 5%. In the results of cluster analysis, patients were classified into three subgroups. Cluster 1 was characterised by worse pain intensity from baseline, cluster 2 by pain, having recovered less and mildly than the predicted value, and Cluster 3 by a marked recovery of pain. In the results of the decision tree analysis, the CSI change was extracted as an indicator related to the classification of all clusters. Our findings suggest that the poor improvement of CSS is characteristic in cases that do not fit the prediction of pain recovery.

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Correlations between the active straight leg raise, sleep and somatosensory sensitivity during pregnancy with post-partum lumbopelvic pain: an initial exploration

Scandinavian Journal of Pain ◽

10.1515/sjpain-2018-0081 ◽

2019 ◽

Vol 19 (1) ◽

pp. 53-60 ◽

Cited By ~ 1

Author(s):

Darren John Beales ◽

Odette Gaynor ◽

Jasmine Harris ◽

Robyn Fary ◽

Peter Bruce O’Sullivan ◽

...

Keyword(s):

Pain Sensitivity ◽

Rating Scale ◽

Short Form ◽

Post Partum ◽

Mcgill Pain Questionnaire ◽

Pain Intensity Score ◽

Pressure Pain ◽

Pressure Pain Thresholds ◽

Straight Leg Raise ◽

Physical Hrqol

Abstract Background and aims For some women, lumbopelvic pain (LPP) developed during pregnancy becomes a continuing post-partum problem. Increased understanding of potential prognostic factors is required. This study investigated whether active straight leg raise (ASLR), sleep dysfunction and pressure pain sensitivity during pregnancy are correlated with LPP intensity and quality, disability, and physical health-related quality of life (HRQoL) post-partum. Methods An exploratory, prospective cohort study design was used. Baseline factors of interest were: (1) ASLR, (2) Pittsburgh Sleep Quality Index, and (3) pressure pain thresholds (PPTs) collected from pregnant women from sites local and distal to the lumbopelvic area. Follow-up data collected 11–18 months post-partum (n=29) were: (1) pain intensity score (numerical rating scale), (2) pain quality (McGill Pain Questionnaire), (3) disability (Pelvic Girdle Questionnaire), and (4) HRQoL (36-item Short Form Health Survey). Correlation analysis was performed. Results Greater difficulty with an ASLR during pregnancy correlated with lower post-partum physical HRQoL scores (r=−0.563, p=0.002). Likewise, reduced PPTs at the sacrum during pregnancy was correlated with a higher post-partum pain quality score (r=−0.384, p=0.040). Conclusions In this cohort, findings indicate that poor ASLR performance and localised pressure pain hypersensitivity at the pelvis during pregnancy are correlated with post-partum physical HRQoL and pain quality, respectively. Implications Pain sensitivity may contribute to the prognosis of women with LPP during pregnancy. These explorative findings may be important for designing larger prognostic studies and may assist in directing potential pain management in post-partum LPP.

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Manual acupuncture versus sham acupuncture and usual care for the prevention of primary dysmenorrhea (PD): study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-020-04720-5 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Lingling Yu ◽

Shiqin Liu ◽

Cuihong Zheng ◽

Wenhua Liu ◽

Hua Wang ◽

...

Keyword(s):

Usual Care ◽

Short Form ◽

Sham Acupuncture ◽

Acupuncture Points ◽

Primary Dysmenorrhea ◽

Efficacy And Safety ◽

Manual Acupuncture ◽

Menstrual Cycles ◽

Randomized Controlled ◽

High Quality Evidence

Abstract Background Primary dysmenorrhea (PD) is a leading cause of dysmenorrhea among adolescent girls. Manual acupuncture may be considered as an effective treatment for PD, but high-quality evidence remains limited. This trial aims to evaluate the efficacy and safety of acupuncture for the prevention of PD as compared with sham acupuncture and usual care. Methods/design This is a three-arm, randomized, controlled clinical trial in which the patients, assessors, and statisticians will be blinded. A total of 300 acupuncture-naive patients who were diagnosed as PD will be randomly allocated to the verum acupuncture, sham acupuncture, or usual care groups in a 2:2:1 ratio. Patients in the verum acupuncture group will receive manual acupuncture at specific acupuncture points with penetrating needling, while those in the sham acupuncture group will receive non-penetrating needling at non-acupuncture points. They will be given five sessions over a menstrual cycle for 3 menstrual cycles. Patients in the usual care group will receive health education and informed to receive manual acupuncture for free after waiting for 7 menstrual cycles. The primary outcome will be the change from baseline in the Cox Menstrual Symptom Scale Score (CMSS). The secondary outcomes will be the changes in Massachusetts General Hospital Acupuncture Sensation Scale (MASS), visual analog scale (VAS), Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2), Pittsburgh Sleep Quality Index (PSQI), Beck Anxiety Inventory (BAI), Beck Depression Inventory II (BDI- II), Acupuncture Expectancy Scale (AES), 60-item NEO Personality Inventory-Short Form (NEO-FFI), and acute medication intake. The adverse events will be recorded at every visit. The analyses will be performed base on a full analysis set (FAS) and a per-protocol set (PPS). Discussion This study may provide high-quality evidence regarding the efficacy and safety of manual acupuncture for PD. In addition, the results of this study will help to identify the efficacy of acupuncture due to the specific effects of acupuncture or placebo effects of acupuncture ritual. Trial registration Clinical Trials.gov NCT02783534. Registered on 26 May 2016

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Predictors of the Pain Perception and Self-Efficacy for Pain Control in Patients with Fibromyalgia

The Spanish Journal of Psychology ◽

10.5209/rev_sjop.2011.v14.n1.33 ◽

2011 ◽

Vol 14 (1) ◽

pp. 366-373 ◽

Cited By ~ 23

Author(s):

Ana I. Sánchez ◽

M. Pilar Martínez ◽

Elena Miró ◽

Ana Medina

Keyword(s):

Self Efficacy ◽

Pain Perception ◽

Pain Catastrophizing ◽

Short Form ◽

Depression Scale ◽

The Self ◽

Mcgill Pain Questionnaire ◽

Efficacy Expectations ◽

And Coping ◽

Pain Anxiety Symptoms Scale

Objective: This study analyzes the role of a number of cognitive-affective dimensions in the experience and coping of pain in patients with fibromyalgia (FM). Specifically, it was examined whether anxiety, depression, pain catastrophizing and pain-related anxiety predict the pain perception and the self-efficacy expectations in these patients.Method: Seventy-four fibromyalgia patients were asked to complete a questionnaire survey including theChronic Pain Self-Efficacy Scale, theHospital Anxiety and Depression Scale, thePain Anxiety Symptoms Scale-20, thePain Catastrophizing Scale, and theShort-form McGill Pain Questionnaire. Results: Some relevant correlation and predicting patterns were identified. Physiological anxiety was the best predictor of the sensorial dimension of pain. Pain fear was a significant predictor of the pain intensity. Helplessness was the best predictor of the affective dimension of pain, whereas depression was a significant predicting variable of the self-efficacy expectations.Conclusions: This study shows the relevance of the pain-related anxiety in the pain perception, and of the depression in the self-efficacy expectations in FM patients. Clinical applications of the findings and further research lines in this area are discussed.

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Anxiety and Depression Affect Early Postoperative Pain Dimensions after Bariatric Surgery

Journal of Clinical Medicine ◽

10.3390/jcm10010053 ◽

2020 ◽

Vol 10 (1) ◽

pp. 53

Author(s):

Sofia Gravani ◽

Maria Matiatou ◽

Pantelis T. Nikolaidis ◽

Evangelos Menenakos ◽

Constantinos G. Zografos ◽

...

Keyword(s):

Bariatric Surgery ◽

Postoperative Pain ◽

Short Form ◽

Depression Scale ◽

Preoperative Anxiety ◽

Anxiety And Depression ◽

Mcgill Pain Questionnaire ◽

Preoperative Pain ◽

Prolonged Hospitalization ◽

Prolonged Immobilization

Uncontrolled postoperative pain and prolonged immobilization after bariatric surgery have been associated with increased postoperative complications and prolonged hospitalization. The aim of our study was to evaluate the postoperative pain that follows bariatric surgery and identify any psychological factors that may affect the early postoperative perception of pain. The study included 100 patients with obesity (women, n = 61; age 37.4 ± 9.9 years, mean ± standard deviation; Body Mass Index (BMI) 47.6 ± 6.5 kg/m2) who underwent bariatric surgery. Preoperative anxiety and depression were evaluated by the Hospital Anxiety and Depression Scale (HADS), and the quantitative and qualitative dimension of early postoperative pain were evaluated by the McGill Pain Questionnaire Short Form (MPQ-SF). Furthermore, the postoperative analgesia protocol was recorded for each patient. Pain declined gradually during the first 24 h postoperative. Although preoperative anxiety had no correlation with the overall pain of postoperative Day 0, patients with a higher level of preoperative anxiety had significantly more intense and more unpleasant pain at 1 h post operation. In addition, depression influences both the intensity and unpleasantness of pain at different time points (1 h, 4 h and 24 h postoperative). Preoperative pain correlated with educational level, but not with age, BMI, gender, marital status, smoking and surgery type. In conclusion, preoperative anxiety and depression influence the early postoperative pain after bariatric surgery, and their preoperative identification is of major importance to enhance the implementation of fast-track postoperative protocols to prevent complications and prolonged hospitalization.

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Acupuncture for Psychosomatic Symptoms of Hwa-byung, an Anger Syndrome: A Feasibility Randomized Controlled Trial

Frontiers in Psychology ◽

10.3389/fpsyg.2021.651649 ◽

2021 ◽

Vol 12 ◽

Author(s):

Yujin Choi ◽

In-Hye Park ◽

Jung-Eun Kim ◽

Ojin Kwon ◽

Ae-Ran Kim ◽

...

Keyword(s):

Effect Size ◽

Controlled Trial ◽

A Priori ◽

Pilot Trial ◽

Sham Acupuncture ◽

Acupuncture Group ◽

Psychosomatic Symptoms ◽

Randomized Controlled ◽

Trial Testing ◽

Sham Acupuncture Group

Objectives: Emerging studies found the potential effects of acupuncture for treating chronic pain and mental disorders, namely, depressive and anxiety disorders. Acupuncture is widely used for treating culture-related anger syndrome, Hwa-byung. This pilot trial aimed to investigate the feasibility of a clinical trial testing acupuncture for the psychosomatic symptoms of Hwa-byung.Methods: A total of 26 patients with Hwa-byung planned to be randomly assigned to the acupuncture or sham acupuncture groups. About 10 treatment sessions were applied over 4 weeks. The 100-mm visual analog scale was used to measure the six major Hwa-byung symptoms: stuffiness in the chest, heat sensations, pushing-up in the chest, feeling a mass in the throat, feelings of unfairness, and hard feelings. The criteria for assessing the success of this pilot trial were defined as improvement in three or more of the six Hwa-byung symptoms after treatment, with an effect size >0.2.Results: A total of 15 patients were finally included and randomly assigned to the acupuncture group (n = 7) or the sham acupuncture group (n = 8). After 10 treatment sessions, the Cohen's d effect sizes for acupuncture compared to sham acupuncture were >0.2 for each one of the six major Hwa-byung symptoms, which met our a priori criteria for success. Also, the effect size for the somatic symptoms of “stuffiness in the chest” was 0.81 (95% CI −0.40, 2.20), referring to a large effect size.Conclusions: Our results suggest that acupuncture treatment would be regarded as an acceptable intervention for a full-scale study of psychosomatic symptoms in patients with Hwa-byung.Trial Registration:cris.nih.go.kr, identifier: KCT0001732.

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Effectiveness of Tuina manipulation in patients with knee osteoarthritis: study protocol for a randomized controlled trial

10.21203/rs.3.rs-20550/v3 ◽

2020 ◽

Author(s):

Zhizhen Lv ◽

Qingguang Zhu ◽

Guangxin Guo ◽

Wuquan Sun ◽

Yanbin Cheng ◽

...

Keyword(s):

Health Care ◽

Randomized Controlled Trial ◽

Knee Osteoarthritis ◽

Short Form ◽

Controlled Trial ◽

Mcgill Pain Questionnaire ◽

Health Care Education ◽

Care Education ◽

Randomized Controlled ◽

Education Group

Abstract Background: Knee osteoarthritis (KOA) is a common musculoskeletal disorder. Previous studies reported that Tuina manipulation showed benificial effects in management of musculoskeletal disorders . However, there was no enough evidence to support the effectiveness of Tuina manipulation for KOA. The purpose of this study is to evaluate the effectiveness of Tuina manipulation on pain and dysfunction of patients with KOA compared with health care education.Methods/Design: This study is a single-centre, two-arm, open-label randomized controlled trial (RCT). A total of 170 eligible KOA patients will be randomly assigned to the Tuina manipulation group or the health care education group in a 1:1 ratio. In the Tuina manipulation group, patients will receive a 30 min treatment including pain point assessment and manual therapy. The health care education group will receive 45 min of lecture and discussion. All treatments will be conducted three times a week for four weeks. The primary outcome is the Knee Injury and Osteoarthritis Outcome Score (KOOS). Secondary outcomes include the McGill Pain Questionnaire (MPQ) and 36-item Short-Form Health Survey (SF-36). The results will show the evidence of the effect of Tuina manipulation for KOA compared with health care education.Discussion: The design and methodology of the trial is rigorous and allows the collection of valuable data to assess the effect of a specific Tuina regimen for the treatment of KOA. Therefore, the trial will provide a solid foundation for future clinical research on KOA and Tuina therapy.Trial registration: This trial was registered with the Chinese Clinical Trial Registry on 24 February 2020 (ChiCTR2000030154), http://www.chictr.org.cn/index.aspx

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