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Objective of the study
In this randomized controlled trial, the main objective is to evaluate the effectiveness of duloxetine in managing diabetic peripheral neuropathic pain. The study aims to provide scientific evidence on the efficacy of duloxetine as a treatment option for this specific type of pain. By comparing the outcomes of patients receiving duloxetine with those receiving a placebo, the study seeks to determine the potential benefits of duloxetine in reducing pain intensity, improving quality of life, and enhancing overall patient well-being. The findings of this study will contribute valuable insights to the medical community and may influence clinical practices related to the management of diabetic peripheral neuropathic pain.
Objective of the study
The objective of this study is to evaluate the efficacy of duloxetine in reducing diabetic peripheral neuropathic pain. The primary goal is to assess the impact of duloxetine treatment on pain intensity, quality of life, and functional impairment in patients with diabetic neuropathy. Secondary objectives include evaluating the safety and tolerability of duloxetine in this patient population and exploring potential factors that may influence treatment response.
To achieve these objectives, a randomized controlled trial design will be utilized, with participants being randomly assigned to receive either duloxetine or placebo. Various outcome measures, including pain scales, quality of life assessments, and adverse event monitoring, will be used to evaluate the effects of treatment.
Methods
The study design for the randomized controlled trial included a comparison of two groups: one receiving duloxetine and the other receiving a placebo. Participants were randomly assigned to either group and were blinded to the treatment they were receiving. The study followed a double-blind protocol, with both participants and researchers unaware of who was receiving duloxetine or the placebo.
Participants underwent initial assessments to determine baseline pain levels and were monitored throughout the study period for changes in pain intensity, quality of life, and any adverse effects. Assessments were conducted at regular intervals using standardized pain scales and questionnaires.
Data analysis was performed using appropriate statistical methods to compare outcomes between the duloxetine and placebo groups. Subgroup analysis was also conducted to evaluate the effects of duloxetine in specific populations, such as those with severe neuropathic pain or comorbidities.
Study design
The study design involved a randomized controlled trial (RCT) to assess the efficacy of duloxetine in treating diabetic peripheral neuropathic pain. Participants were randomly assigned to either the duloxetine group or placebo group. The study was double-blind, meaning neither the participants nor the researchers knew which treatment each participant received. This minimized bias in the results. The participants were monitored over a specific period to evaluate the impact of duloxetine on their pain levels and quality of life.
Participants and procedures
The study included a total of 300 participants with diagnosed diabetic peripheral neuropathic pain. Participants were randomly assigned to either the duloxetine treatment group or the placebo group. The inclusion criteria required participants to be adults over the age of 18 with a documented history of diabetes and neuropathic pain. Exclusion criteria included the presence of any other chronic pain conditions, use of other medications for neuropathic pain, and any medical conditions that could interfere with the study results.
Participants in the duloxetine treatment group received a daily dose of 60mg of duloxetine for a duration of 12 weeks. The placebo group received a matching placebo pill following the same administration schedule. Participants were required to visit the research center for regular follow-up visits to assess pain levels, side effects, and overall treatment response. Additionally, participants were instructed to keep a daily pain diary to track their symptoms and medication adherence.
Results
The main findings of the randomized controlled trial of duloxetine in diabetic peripheral neuropathic pain revealed a statistically significant reduction in pain scores among participants who received duloxetine compared to those who received a placebo. The study also showed improvements in functional status and quality of life measures in the duloxetine group. Subgroup analysis suggested that the treatment effect of duloxetine was consistent across different demographic and clinical characteristics, indicating the broad efficacy of duloxetine in treating diabetic neuropathic pain. Overall, the results support the use of duloxetine as an effective treatment option for diabetic peripheral neuropathic pain.
Main findings
The main findings of the study revealed that duloxetine was effective in reducing diabetic peripheral neuropathic pain compared to placebo. Patients who received duloxetine reported a significant decrease in pain intensity and improvement in quality of life measures. The medication was well-tolerated with minimal side effects reported. Additionally, subgroup analysis showed that the efficacy of duloxetine was consistent across different age groups and disease durations.
Subgroup analysis
The subgroup analysis was conducted to explore the differential effects of duloxetine in diabetic peripheral neuropathic pain based on various participant characteristics. The study aimed to identify any subgroups that may benefit more or less from duloxetine treatment.
Age
The analysis indicated that older participants (above 65 years) experienced a more significant reduction in neuropathic pain scores compared to younger individuals.
Diabetes Duration
Participants with a longer duration of diabetes (over 10 years) showed a better response to duloxetine treatment in terms of pain relief.