scholarly journals Comparative effect of electroacupuncture with different frequency on headache attacks in migraine outpatients: study protocol for a randomised placebo-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Na Nie ◽  
Le Chen ◽  
Tong Li ◽  
Chuanlong Zhou ◽  
Bangwei Li ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Depression Scale ◽  
Secondary Outcome ◽  
Control Group ◽  
Placebo Control ◽  
Life Questionnaire ◽  
Clinical Trial Registry ◽  
The Past ◽  
Self Rating ◽  
Post Randomisation

Abstract Background Headache attacks severely impaired life quality and increase the economic burden of migraineurs. Electroacupuncture (EA) has been used worldwidely to treat several pain-related diseases including migraines. However, whether EA with low or high frequency exerts a distinct analgesic effect remains unknown and needs further study. Methods/Design This study is a randomised, single-blinded, placebo-controlled trial with three parallel arms. A total of 144 migraine outpatients will be randomly allocated to the 2 Hz EA group, 100 Hz EA group and placebo control group. The duration of the trial is 20 weeks, including a 4-week-long baseline assessment period (weeks − 4–0), a 4-week-long treatment period (weeks 1–4) and a 12-week-long follow-up period (weeks 5–16). Twelve treatment sessions will be performed over a 4-week period (weeks 1–4). The primary outcome will be measured by the frequency of migraine attacks in the past 4 weeks at the end of week 4 post-randomisation. The secondary outcome will be measured by the frequency of migraine attacks in the past 4 weeks at the end of weeks 8, 12 and16 post-randomisation; number of days with migraine; dosage of ibuprofen; the scores of visual analogue scale (VAS); Self-Rating Anxiety Scale (SAS); Self-Rating Depression Scale (SDS); and Migraine Specific Quality of Life questionnaire (MSQ) in the past 4 weeks at the end of weeks 4, 8, 12 and 16 post-randomisation. Safety assessment, compliance and blinding evaluation will be carried out at the end of week 16 post-randomisation. Discussion The recruitment will be started on 1 June 2021 and expected to finish on 31 May 2023. We aimed to clarify the dominant frequency of EA on headache attacks in a migraineur. Trial registration Chinese Clinical Trial Registry ChiCTR-1800017259. Registered on 20 July 2018. 

Comparative effect of electroacupuncture with different frequency on headache attacks in migraine outpatients: study protocol for a randomised placebo- controlled trial

2021 ◽  
Author(s):  
Na Nie ◽  
Le Chen ◽  
Tong Li ◽  
Chuanlong Zhou ◽  
Bangwei Li ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Depression Scale ◽  
Secondary Outcome ◽  
Control Group ◽  
Placebo Control ◽  
Life Questionnaire ◽  
Clinical Trial Registry ◽  
The Past ◽  
Self Rating ◽  
Post Randomisation

Abstract Background: Headache attacks severely impaired life quality and increase economic burden of migraineurs. Electroacupuncture (EA) has been used world-widely to treat several pain-related diseases including migraine. However, whether EA with low- or high-frequency exerts distinct analgesic effect remains unknown and need to further study. Methods/Design: This study is a randomised, single-blinded, placebo-controlled trial with three parallel arms. A total of 144 migraine outpatients will be randomly allocated to 2Hz EA group, 100Hz EA group and placebo control group. The duration of the trial is 20 weeks, including a 4-week long baseline assessment period (week-4-0), 4-week long treatment period (week 1-4), and 12-week long follow-up period (week 5-16). Twelve treatment sessions will be performed over a four-week period (week 1-4). The primary outcome will be measured by frequency of migraine attacks in the past 4 week at the end of week 4 post-randomisation. Secondary outcome will be measured by frequency of migraine attacks in the past 4 week at the end of week 8,12,16 post-randomisation, number of days with migraine, dosage of ibuprofen, the scores of Visual Analogue Scale (VAS), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS) and Migraine Specific Quality of Life questionnaire (MSQ) in the past 4 week at the end of week 4, 8, 12, 16 post-randomisation. Safety assessment, compliance and blinding evaluation will be carried out at the end of week 16 post-randomisation. Discussion: The recruitment will be started at 1 June, 2021 and expected to finish at 31 May, 2023. We aimed to clarify the dominant frequency of EA on headache attacks in migraineur. Trial registration: Chinese Clinical Trial Registry, ChiCTR-1800017259. Registered on 20 July 2018.

scholarly journals Comparative effect of electroacupuncture with different frequency on headache attacks in migraine outpatients: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Na Nie ◽  
Le Chen ◽  
Tong Li ◽  
Chuanlong Zhou ◽  
Bangwei Li ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Life Quality ◽  
Depression Scale ◽  
Secondary Outcome ◽  
Control Group ◽  
Life Questionnaire ◽  
Comparative Effect ◽  
Clinical Trial Registry ◽  
Self Rating ◽  
And Control

Abstract Background: Headache attacks severely impaired life quality and increase economic burden of migraineurs. Electroacupuncture (EA) has been used world-widely to treat several pain-related diseases including migraine. However, whether EA with low- or high-frequency exerts distinct analgesic effect remains unknown and need to further study.Methods/Design: This study is a randomized, prospective randomized trial with three parallel arms. A total of 129 migraine outpatients will be randomly allocated to 2Hz EA group, 100Hz EA group and control group. Twelve treatment sessions will be performed over a four-week period. The primary outcome will be measured by frequency of migraine attacks at baseline, four-week of treatment and consecutive four-week follow-up. Secondary outcome measures will be number of days with migraine, frequency of taking ibuprofen, Visual Analogue Scale (VAS), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS) and Migraine Specific Quality of Life questionnaire (MSQ), safety and compliance evaluation.Discussion: This trial is expected to comparative effect of electroacupuncture with different frequency on headache attacks in migraineur.Trial registration: Chinese Clinical Trial Registry, ChiCTR-1800017259.Registered on 20 July 2018.Registered on 20 July 2018.

scholarly journals Open-labelled randomised controlled trial of 12 hours versus 24 hours modified Pritchard regimen in the management of eclampsia and pre-eclampsia in Ghana (MOPEP Study): study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e032799 ◽  
Author(s):  
Titus Beyuo ◽  
Emma Lawrence ◽  
Elizabeth S Langen ◽  
Samuel A Oppong
Keyword(s):  
Randomised Controlled Trial ◽  
Health Outcomes ◽  
Magnesium Sulfate ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
University Of Michigan ◽  
Clinical Trial Registry ◽  
Randomised Controlled ◽  
Study Participants

IntroductionHypertensive disorders of pregnancy continue to be a major contributor to maternal and perinatal morbidity and mortality. Magnesium sulfate therapy is the standard of care for seizure prophylaxis and treatment for pre-eclampsia and eclampsia respectively, despite wide disparities in dosing regimens and routes of administration. This study compares the clinical efficacy of magnesium sulfate in the reduction of seizure occurrence or recurrence with the 12 hours versus 24 hours modified Pritchard regimens in the management of severe pre-eclampsia and eclampsia.Methods and analysisThis study is an open labelled randomised controlled trial. The study participants are patients admitted to the Korle Bu Teaching Hospital (KBTH) in Accra, Ghana with a diagnosis of antepartum, intrapartum or postpartum eclampsia or pre-eclampsia with severe features. All study participants will be administered a loading dose of magnesium sulfate, followed by maintenance dosing. Participants in the control group will receive magnesium sulfate for 24 hours after diagnosis, while those in the treatment group will receive magnesium sulfate for 12 hours after diagnosis. The primary outcome of this study is the occurrence of a seizure any time after the completion of treatment in the assigned group. Secondary outcome measures include maternal health outcomes, magnesium sulfate toxicities and fetal health outcomes. Data collection was started in October 2018 with a target enrolment of 1245 participants with severe pre-eclampsia and 844 participants with eclampsia with a projected study period of 2–3 years.Ethics and disseminationEthical approval was obtained from the KBTH Institutional Review Board (IRB) in Ghana. University of Michigan involvement is limited to protocol development and statistical analysis of de-identified data, and has been granted a Not Regulated Determination by the University of Michigan IRB. Results of the study will be shared at clinical forums at the KBTH and will be submitted for publication in an international peer-reviewed journal.Trial registration numberPan African Clinical Trial Registry through the South African Medical Research Council (PACTR201811515303983).

scholarly journals Efficacy of acetaminophen with and without oxycodone for analgesia in nonoperative treatment of extremity fractures in adults: Protocol for a double-blind randomized clinical trial

2019 ◽  
Author(s):  
Tao Gao ◽  
Hongyi Zhu ◽  
Changqing Zhang ◽  
Yimin Chai ◽  
Cheng Guo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Nonoperative Treatment ◽  
Secondary Outcome ◽  
Control Group ◽  
Double Blind ◽  
Randomized Controlled ◽  
Limb Fracture ◽  
Self Rating ◽  
Limb Fractures

Abstract Background: Opioids and acetaminophen are both widely used to relieve pain after nonoperative treatment of limb fractures, but evidence for superiority of opioids versus acetaminophen is lacking. In this study we aim to determine whether acetaminophen is noninferior to the acetaminophen/oxycodone combination for pain relief after nonoperative fixation of an extremity limb fracture. We hypothesize that acetaminophen is noninferior to the acetaminophen/oxycodone combination. Methods: A double-blind, randomized controlled trial will be conducted. Power analysis determined that 1,226 participants will be needed (p<0.05, power 90%). Patients with acute limb fracture who receive nonoperative treatment will be recruited and randomly allocated into two groups: the intervention group will receive oral oxycodone (5 mg)/acetaminophen (325 mg), and the control group will receive acetaminophen (650 mg) only. The primary outcome measure will be scores on the 11-point Numeric Rating Scale (NRS-11) over 14 days. Secondary outcome measures are scores on the Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), EuroQol five dimensions’ questionnaire (EQ-5d), self-rated satisfaction with the analgesia produced, self-reported nighttime sleep duration, number of intervention or control pills used, total duration for taking intervention or control medication. Change of pain scores and the number of times that analgesic drugs were taken in the two groups will be statistically evaluated with t-student tests according to their fracture site. Discussion: This study will be a randomized controlled trial that is adequately powered to test the hypothesis that acetaminophen is noninferior to the combination of acetaminophen and oxycodone in relieving objectively measured pain after nonoperative treatment of limb fractures in adults. It is hopeful to provide a safe and effective analgesic plan for such patients. Trial Registration: ChiCTR registry: ChiCTR1800017015 ( http://www.chictr.org.cn/showproj.aspx?proj=28612). Registered on 8 July 2018. Keywords: Opioids, acetaminophen, fracture, nonoperative treatment.

scholarly journals Electroacupuncture Plus Auricular Acupressure on Chemotherapy-Related Insomnia in Patients With Breast Cancer (EACRI): Study Protocol for a Randomized, Sham-Controlled Trial

2021 ◽  
Vol 20 ◽  
pp. 153473542110586
Author(s):  
Jialing Zhang ◽  
Mingxiao Yang ◽  
Tsz Him So ◽  
Tien Yee Chang ◽  
Zongshi Qin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Short Form ◽  
Controlled Trial ◽  
Depression Scale ◽  
Acupuncture Group ◽  
Sleep Diary ◽  
Secondary Outcome ◽  
Control Group ◽  
Efficacy And Safety ◽  
Auricular Acupressure

Objective Insomnia is a highly prevalent and disturbing symptom in breast cancer patients under or post chemotherapy. If not appropriately treated, it can persist for years after the completion of cancer treatments. Acupuncture has been widely used for alleviating insomnia. The aim of this study is to examine the feasibility, efficacy and safety of acupuncture for chemotherapy-related insomnia among patients with breast cancer. Materials and Methods This is a trial protocol for a randomized, sham-controlled, subject- and assessor-blinded clinical trial. A total of 138 eligible participants will be assigned randomly to acupuncture or sham control group at a ratio of 1:1. Participants in acupuncture group will receive electroacupuncture (EA) plus auricular acupressure (AA) treatment, while subjects in sham acupuncture group will receive sham EA plus sham AA. Both acupuncture and sham treatments will be given twice weekly for 6 weeks, followed by maintenance treatments once every 4 weeks for 12 weeks (15 sessions totally). The primary outcome is the change of Insomnia Severity Index score between baseline and the end of 6-week treatment. Secondary outcome measurements include Actiwatch, sleep diary, Pittsburgh Sleep Quality Index, Functional Assessment of Cancer Therapy-Breast Cancer, Hospital Anxiety and Depression Scale, Brief Pain Inventory-Short Form, Brief Fatigue Inventory, Acupuncture Expectancy Scale, credibility, and adverse events. Participants will be followed up to 42 weeks. Conclusions This trial will expand our understanding of the feasibility, efficacy, and safety of acupuncture as a treatment for alleviating chemotherapy-related insomnia in patients with breast cancer. EA plus AA, if proven to be effective, can be implemented into routine settings to play a role in insomnia management for patients with breast cancer.

scholarly journals Effect of acupuncture on insomnia in menopausal women: A Study protocol for a Randomized Controlled Trial

2018 ◽  
Author(s):  
Shanshan Li ◽  
Ping Yin ◽  
Xuan Yin ◽  
Anna Bogachko ◽  
Tingting Liang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Depression Scale ◽  
Menopausal Transition ◽  
Syndrome Differentiation ◽  
Control Group ◽  
Randomized Controlled ◽  
Self Rating ◽  
Menopausal Women

Abstract Background: China today has high occurrences of insomnia in perimenopausal women. Some studies have shown that acupuncture might be effective in treating primary insomnia and insomnia related to depression and stroke. Although there are some programs supporting insomnia during the menopausal transition, there are few randomized controlled trials to provide evidence regarding their effectiveness. We design a randomized controlled trial of suitable sample size to verify the effectiveness of acupuncture in patients with insomnia during the menopausal transition and to form an optimized acupuncture treatment protocol. Method/Design: In this randomized, single-site, single-blind, placebo-controlled trial, 84 eligible patients will be recruited and randomly assigned to either the acupuncture group (n = 42) or the sham control group (n = 42) in a 1:1 ratio. Participants will receive a total of 18 sessions of treatment for eight consecutive weeks. Treatments will be given three times per week in the first four weeks, twice a week for the next two weeks and finally treatment once weekly for the final two weeks. Treatment will utilize eight main acupoints (GV20, GV24, GV29, RN6, RN4, SP6, HT7, EX-HN22), and extra two acupoints based on syndrome differentiation. The primary outcome will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will be measured by sleep parameters recorded in the Actigraphy (SE, TST, SA), Insomnia Severity Index (ISI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS) and Menopause Quality of Life (Men-QOL). The primary outcomes will be assessed at baseline, week four, week eight, and first and the third month following the end of treatment. Discussion: If the results confirm that acupuncture is effective and safe for the treatment on insomnia in menopausal women, this positive outcome could provide evidence for clinical application.

scholarly journals Efficacy and safety of the extracorporeal shock wave therapy in patients with postherpetic neuralgia: study protocol of a randomized controlled trial

2020 ◽  
Author(s):  
Lu Chen ◽  
Ruihao Zhou ◽  
Fuguo Sun ◽  
Yan Weng ◽  
Ling Ye ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Postherpetic Neuralgia ◽  
Controlled Trial ◽  
Interventional Therapy ◽  
Secondary Outcome ◽  
Control Group ◽  
Medication Therapy ◽  
Randomized Controlled ◽  
Self Rating ◽  
Experimental Group

Abstract Background: Postherpetic neuralgia (PHN) is one of the most common chronic neuropathic pain, which seriously affected the quality of the life due to the severity of pain and the poor response to the current treatment. The main management strategies of PHN include medication therapy and invasive interventional therapy. However, there are lots of side effects. It is meaningful to find another effective and safe treatment for PHN. Methods: A single-center, randomized, single-blind clinical trial will be held. A total of 98 participants will be randomly divided into control group and experimental group in a 1:1 ratio. Patients in control group will receive conventional treatment including medication therapy and invasive interventional therapy. The experimental group will be treated with extracorporeal shockwave therapy (ESWT) in addition to conventional therapy. The primary outcome is visual analogue scale (VAS), secondary outcome contains 36-item short-form health survey (SF-36), self-rating anxiety Scale (SAS), self-rating depression scale (SDS) and Pittsburgh sleep quality index (PSQI). Assessors who are blinded to the randomization will collect data during the intervention period at baseline, 1 weeks, 4 weeks, and 12 weeks in this study. The plasma levels of TNF-α、IL-6 in patients will be detected before and after ESWT to explore part of the biochemical mechanism of ESWT for the treatment of PHN. Discussion: This randomized controlled trial will be held to evaluate the actual effectiveness and safety of ESWT in patients with PHN, and thus provide clinical evidences for its application in the PHN management and explore the potential mechanism of this treatment. Trial registration: www.ChiCTR.org.cn, identifier: ChiCTR1900025828. Registered on 10th September 2019.

scholarly journals Effect of acupuncture on insomnia in menopausal women: A Study protocol for a Randomized Controlled Trial

2019 ◽  
Author(s):  
Shanshan Li ◽  
Ping Yin ◽  
Xuan Yin ◽  
Anna Bogachko ◽  
Tingting Liang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Depression Scale ◽  
Menopausal Transition ◽  
Syndrome Differentiation ◽  
Control Group ◽  
Randomized Controlled ◽  
Self Rating ◽  
Menopausal Women

Abstract Background China today has high occurrences of insomnia in women experiencing menopausal transition. Some studies have shown that acupuncture might be effective in treating primary insomnia and insomnia related to depression and stroke. Although there are some programs supporting insomnia during the menopausal transition, there are few randomized controlled trials to provide evidence regarding their effectiveness. We design a randomized controlled trial of suitable sample size to verify the effectiveness of acupuncture in patients with insomnia during the menopausal transition and to form an optimized acupuncture treatment protocol. Method/Design In this randomized, single-site, single-blind, placebo-controlled trial, 84 eligible patients will be recruited and randomly assigned to either the acupuncture group (n = 42) or the sham control group (n = 42) in 1:1 ratio. Participants will receive 18 sessions of treatment in total for eight consecutive weeks. Treatments will be given three times per week in the first four weeks and then twice a week for the next two weeks followed by once a week treatment for the final two weeks. Treatment will utilize eight main acupoints (GV20, GV24, GV29, RN6, RN4, SP6, HT7, EX-HN22), and extra two acupoints based on syndrome differentiation. The primary outcome will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will be measured by sleep parameters recorded in the Actigraphy (SE, TST, SA), Insomnia Severity Index (ISI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS) and Menopause Quality of Life (Men-QOL). The primary outcomes will be assessed at baseline, four-week, eight-week, and first and the third month after the end of treatment. Discussion If the results confirm that acupuncture is effective and safe for the treatment on insomnia in menopausal women, they could provide evidence for clinical application.

scholarly journals Effect of acupuncture on insomnia in menopausal women: A Study protocol for a Randomized Controlled Trial

2019 ◽  
Author(s):  
Shanshan Li ◽  
Ping Yin ◽  
Xuan Yin ◽  
Anna Bogachko ◽  
Tingting Liang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Depression Scale ◽  
Menopausal Transition ◽  
Control Group ◽  
Randomized Controlled ◽  
Self Rating ◽  
Menopausal Women

Abstract Background: China today has high occurrences of insomnia in perimenopausal women. Some studies have shown that acupuncture might be effective in treating primary insomnia and insomnia related to depression and stroke. Although there are some programs supporting insomnia during the menopausal transition, there are few randomized controlled trials to provide evidence regarding their effectiveness. We design a randomized controlled trial of suitable sample size to verify the effectiveness of acupuncture in patients with insomnia during the menopausal transition and to form an optimized acupuncture treatment protocol. Method: In this randomized, single-site, single-blind, placebo-controlled trial, 84 eligible patients will be recruited and randomly assigned to either the acupuncture group (n = 42) or the sham control group (n = 42) in a 1:1 ratio. Participants will receive a total of 18 sessions of treatment for eight consecutive weeks. Treatments will be given three times per week in the first four weeks, twice a week for the next two weeks and finally treatment once weekly for the final two weeks. Treatment will utilize eight main acupoints (GV20, GV24, GV29, RN6, RN4, SP6, HT7, EX-HN22), and extra two acupoints based on syndrome differentiation. The primary outcome will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will be measured by sleep parameters recorded in the Actigraphy (SE, TST, SA), Insomnia Severity Index (ISI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS) and Menopause Quality of Life (Men-QOL). The primary outcomes will be assessed at baseline, week four, week eight, and first and the third month following the end of treatment. Discussion: If the results confirm that acupuncture is effective and safe for the treatment on insomnia in menopausal women, this positive outcome could provide evidence for clinical application. Trial Registration: Chinese Clinical Trial Registry, ChiCTR1800018645, Date: 2018-10-01. URL: http://www.chictr.org.cn/showproj.aspx?proj=31482. Keywords: Menopause; Insomnia; Acupuncture; Clinical trial.

scholarly journals Effectiveness of a Single Education and Counseling Intervention in Reducing Anxiety in Women Undergoing Hysterosalpingography: A Randomized Controlled Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Alfredo La Fianza ◽  
Carolina Dellafiore ◽  
Daniele Travaini ◽  
Davide Broglia ◽  
Francesca Gambini ◽  
...  
Keyword(s):  
Ad Hoc ◽  
Controlled Trial ◽  
Intervention Group ◽  
Depression Scale ◽  
Control Group ◽  
Counseling Intervention ◽  
Self Rating ◽  
Before And After ◽  
Randomised Controlled ◽  
Infertility Patients

Hysterosalpingography (HSG) is generally considered a stressful and painful procedure; we aimed to evaluate whether a single education and counseling intervention could reduce women’s distress and pain after undergoing HSG for infertility. Patients were randomized into control group (n=108) and intervention group (n=109). All patients filled the following questionnaires before and after HSG: Zung self-rating anxiety scale (Z-SAS), Zung self-rating depression scale (Z-SDS), and an ad hoc questionnaire designed to evaluate HSG procedure knowledge. Pain was scored using a visual analog scale. The intervention consisted in a 45-minute individualised session 48 h before HSG. We observed a reduction of anxiety and depression scores in the intervention arm compared to the control group. After controlling for potential confounding variables, intervention was an independent predictor of the difference of Z-SAS score before and after HSG. This is the first randomised controlled trial to assess the potential effectiveness of a single education and counseling intervention to lower anxiety in a diagnostic setting.

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