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

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 (10 mg)/acetaminophen (650 mg), and the control group will receive acetaminophen (650 mg) only. All participants will be instructed to take one pill of study medication on an as-needed basis and no more frequently than once every 8 hours. 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 numbers: ChiCTR registry: ChiCTR1800017015 ( http://www.chictr.org.cn/showproj.aspx?proj=28612). Registered on 8 July 2018.

Download Full-text

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

10.21203/rs.2.317/v2 ◽

2019 ◽

Author(s):

Tao Gao ◽

Hongyi Zhu ◽

Changqing Zhang ◽

Yimin Chai ◽

Cheng Guo ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Nonoperative Treatment ◽

Secondary Outcome ◽

Double Blind ◽

Randomized Controlled ◽

Limb Fracture ◽

Self Rating ◽

Combination Methods ◽

Limb Fractures

Abstract Backgroud 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 numbers ChiCTR registry: ChiCTR1800017015 (http://www.chictr.org.cn/showproj.aspx?proj=28612). Registered on 8 July 2018.

Download Full-text

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

10.21203/rs.2.317/v1 ◽

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.

Download Full-text

Chinese Classical Prescription (Liang-Xue-Di-Huang Decoction) for Hemorrhoidal Disease: study protocol for a randomized controlled trial

10.21203/rs.2.12183/v1 ◽

2019 ◽

Author(s):

Qing Zhou ◽

Shuo-yang Shi ◽

Ben-sheng Wu ◽

Cheng-biao Xu ◽

Ji Geng ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Hemorrhoidal Disease ◽

Secondary Outcome ◽

Efficacy And Safety ◽

Clinical Trial Registry ◽

Double Blind ◽

Randomized Controlled ◽

Objective Evidence ◽

Agent Group

Abstract Background: Hemorrhoidal disease (HD) is one of the commonest proctologic condition in the general population. Medical therapy for HD has not been formally confirmed due to the inconsistent of results. Liang-Xue-Di-Huang Decoction, a kind of ancient Chinese classical prescription, has been used to treat HD from the 19th century in China. However, clinical research of Liang-Xue-Di-Huang Decoction in the treatment of HD is lack. We designed this study to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction in the treatment of HD. Methods/Design: A randomized, controlled, double blind, double-mimetic agent and multicenter trial to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction is proposed. HD patients (stage I, Ⅱ, Ⅲ) will be randomly assigned into Liang-Xue-Di-Huang Decoction with the addition of Diosmine mimetic agent group and Diosmine with the addition of Liang-Xue-Di-Huang Decoction mimetic agent group. Patients will receive a 7-day treatments and a 7-day follow-up. The primary outcome measure is the French Bleeding Score in 7 and 14 days. The Secondary outcome measures are Goligher Prolapse Score and Quality-of-Life Score in 7 and 14 days. Discussion: This study will provide objective evidence to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction in treatment of HD. Trial registration: Chinese Clinical Trial Registry. ChiCTR-1900022531.Registered 19 Apr 2019, http://www.chictr.org.cn/listbycreater.aspx. Keywords: Hemorrhoidal disease, Liang-Xue-Di-Huang Decoction, Chinese classical prescription, Randomized controlled trial.

Download Full-text

Traditional Chinese Medicine Qingre Huoxue Treatment vs. the Combination of Methotrexate and Hydroxychloroquine for Active Rheumatoid Arthritis: A Multicenter, Double-Blind, Randomized Controlled Trial

Frontiers in Pharmacology ◽

10.3389/fphar.2021.679588 ◽

2021 ◽

Vol 12 ◽

Author(s):

Xun Gong ◽

Wei-Xiang Liu ◽

Xiao-Po Tang ◽

Jian Wang ◽

Jian Liu ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Randomized Controlled Trial ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Controlled Trial ◽

The Other ◽

Secondary Outcome ◽

Double Blind ◽

Randomized Controlled ◽

Das 28

Traditional Chinese medicine (TCM) has been used successfully to treat rheumatoid arthritis (RA). Qingre Huoxue treatment (Qingre Huoxue decoction (QRHXD)/Qingre Huoxue external preparation (QRHXEP)) is a therapeutic scheme of TCM for RA. To date, there have been few studies comparing the efficacy and safety of QRHXD and conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for the treatment of active RA. This was investigated in a multicenter, double-blind, randomized controlled trial involving 468 Chinese patients with active RA [disease activity score (DAS)-28 > 3.2] treated with QRHXD/QRHXEP (TCM group), methotrexate plus hydroxychloroquine [Western medicine (WM) group], or both [integrative medicine (IM) group]. Patients were followed up for 24 weeks. The primary outcome measure was the change in DAS-28 from baseline to 24 weeks. The secondary outcome measures were treatment response rate according to American College of Rheumatology 20, 50, and 70% improvement criteria (ACR-20/50/70) and the rate of treatment-related adverse events (TRAEs). The trial was registered at ClinicalTrials.gov (NCT02551575). DAS-28 decreased in all three groups after treatment (p < 0.0001); the score was lowest in the TCM group (p < 0.05), while no difference was observed between the WM and IM groups (p > 0.05). At week 24, ACR-20 response was 73.04% with TCM, 80.17% with WM, and 73.95% with IM (based on the full analysis set [FAS], p > 0.05); ACR-50 responses were 40.87, 47.93, and 51.26%, respectively, (FAS, p > 0.05); and ACR-70 responses were 20.87, 22.31, and 25.21%, respectively, (FAS, p > 0.05). Thus, treatment efficacy was similar across groups based on ACR criteria. On the other hand, the rate of TRAEs was significantly lower in the TCM group compared to the other groups (p < 0.05). Thus, QRHXD/QRHXEP was effective in alleviating the symptoms of active RA—albeit to a lesser degree than csDMARDs—with fewer side effects. Importantly, combination with QRHXD enhanced the efficacy of csDMARDs. These results provide evidence that QRHXD can be used as an adjunct to csDMARDs for the management of RA, especially in patients who experience TRAEs with standard drugs.Clinical Trial Registration: ClinicalTrials.gov, identifier NCTNCT025515.

Download Full-text

A Double-blind Randomized Controlled Trial for the Effects of Dry Needling on Upper Limb Dysfunction in Patients with Stroke

Acupuncture & Electro-Therapeutics Research ◽

10.3727/036012921x16112663844923 ◽

2021 ◽

Vol 45 (2) ◽

pp. 115-124

Author(s):

Zahra Tavakol ◽

Ardalan Shariat ◽

Noureddin Nakhostin Ansari ◽

Shima Ghannadi ◽

Roshanak Honarpishe ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Range Of Motion ◽

Outcome Measures ◽

Upper Limb ◽

Controlled Trial ◽

Secondary Outcome ◽

Upper Limbs ◽

Dry Needling ◽

Double Blind ◽

Randomized Controlled

Spasticity is one of the main complications of a stroke. This double-blind, randomized controlled trial aimed to compare the result of three sessions of dry needling (DN) versus sham DN on the affected upper limbs in post-stroke survivors. We recruited 24 patients (age 57.0 ± 9.6 years; male 71%). Patients were randomly allocated to two groups: a DN group and a sham DN group. The primary outcome measures were the Modified Modified Ashworth Scale (MMAS) and the Box and Block Test (BBT). Secondary outcome measures included active and passive wrist range of motion (AROM and PROM). All assessments were measured at baseline, immediately after the last session of the intervention, and one month later. Patients in the DN group had improved upper limb spasticity and passive wrist range of motion compared to control group (P < 0.05). There were no between-group differences in other outcome measures (P > 0.05). Dry needling is a useful method for improving muscle spasticity in the upper limbs of patients with stroke.

Download Full-text

Augmenting Outpatient Alcohol Treatment as Usual With Online Alcohol Avoidance Training: Protocol for a Double-Blind Randomized Controlled Trial (Preprint)

10.2196/preprints.9287 ◽

2017 ◽

Author(s):

Marleen KJ Bratti-van der Werf ◽

Melissa C Laurens ◽

Marloes G Postel ◽

Marcel E Pieterse ◽

Somaya Ben Allouch ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Outpatient Treatment ◽

Avoidance Training ◽

Controlled Trial ◽

Treatment Setting ◽

Secondary Outcome ◽

Double Blind ◽

Treatment As Usual ◽

Randomized Controlled ◽

Number Of Patients

BACKGROUND Recent theoretical models emphasize the role of impulsive processes in alcohol addiction, which can be retrained with computerized Cognitive Bias Modification (CBM) training. In this study, the focus is on action tendencies that are activated relatively automatically. OBJECTIVE The aim of the study is to examine the effectiveness of online CBM Alcohol Avoidance Training using an adapted Approach-Avoidance Task as a supplement to treatment as usual (TAU) in an outpatient treatment setting. METHODS The effectiveness of 8 online sessions of CBM Alcohol Avoidance Training added to TAU is tested in a double-blind, randomized controlled trial with pre- and postassessments, plus follow-up assessments after 3 and 6 months. Participants are adult patients (age 18 years or over) currently following Web-based or face-to-face TAU to reduce or stop drinking. These patients are randomly assigned to a CBM Alcohol Avoidance or a placebo training. The primary outcome measure is a reduction in alcohol consumption. We hypothesize that TAU + CBM will result in up to a 13-percentage point incremental effect in the number of patients reaching the safe drinking guidelines compared to TAU + placebo CBM. Secondary outcome measures include an improvement in health status and a decrease in depression, anxiety, stress, and possible mediation by the change in approach bias. Finally, patients’ adherence, acceptability, and credibility will be examined. RESULTS The trial was funded in 2014 and is currently in the active participant recruitment phase (since May 2015). Enrolment will be completed in 2019. First results are expected to be submitted for publication in 2020. CONCLUSIONS The main purpose of this study is to increase our knowledge about the added value of online Alcohol Avoidance Training as a supplement to TAU in an outpatient treatment setting. If the added effectiveness of the training is proven, the next step could be to incorporate the intervention into current treatment. CLINICALTRIAL Netherlands Trial Register NTR5087; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5087 (Archived at WebCite http://www.webcitation.org/6wuS4i1tH)

Download Full-text

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

10.21203/rs.3.rs-18731/v1 ◽

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.

Download Full-text