Such interventions would have the potential to reduce the prevalence of chronic pain in the population .
Although certain risk factors can identify individuals who are most likely to develop chronic pain , few interventions to prevent chronic pain have been identified .
To facilitate the identification of preventive interventions , an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain .
We present general design considerations for prevention trials in population s that are at relatively high risk for developing chronic pain .
Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial.
IMPORTANCE There are no known effective treatments for painful chemotherapy-induced peripheral neuropathy . OBJECTIVE To determine the effect of duloxetine , 60 mg daily , on average pain severity . DESIGN , SETTING , AND PATIENTS R and omized , double-blind , placebo-controlled crossover trial at 8 National Cancer Institute (NCI)-funded cooperative research networks that enrolled 231 patients who were 25 years or older being treated at community and academic setting s between April 2008 and March 2011 . Study follow-up was completed July 2012 . Stratified by chemotherapeutic drug and comorbid pain risk , patients were r and omized to receive either duloxetine followed by placebo or placebo followed by duloxetine .  Eligibility required that patients have grade 1 or higher sensory neuropathy according to the NCI Common Terminology Criteria for Adverse Events and at least 4 on a scale of 0 to 10 , representing average chemotherapy-induced pain , after paclitaxel , other taxane , or oxaliplatin treatment . INTERVENTIONS The initial treatment consisted of taking 1 capsule daily of either 30 mg of duloxetine or placebo for the first week and 2 capsules of either 30 mg of duloxetine or placebo daily for 4 additional weeks . MAIN OUTCOME MEASURES The primary hypothesis was that duloxetine would be more effective than placebo in decreasing chemotherapy-induced peripheral neuropathic pain . Pain severity was assessed using the Brief Pain Inventory-Short Form " average pain " item with 0 representing no pain and 10 representing as bad as can be imagined . RESULTS Individuals receiving duloxetine as their initial 5-week treatment reported a mean decrease in average pain of 1.06 ( 95 % CI , 0.72 - 1.40 ) vs 0.34 ( 95 % CI , 0.01 - 0.66 ) among those who received placebo ( P = .003 ; effect size , 0.513 ) . The observed mean difference in the average pain score between duloxetine and placebo was 0.73 ( 95 % CI , 0.26 - 1.20 ) . Fifty-nine percent of those initially receiving duloxetine vs 38 % of those initially receiving placebo reported decreased pain of any amount . CONCLUSION AND RELEVANCE Among patients with painful chemotherapy-induced peripheral neuropathy , the use of duloxetine compared with placebo for 5 weeks result ed in a greater reduction in pain . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00489411
Such interventions would have the potential to reduce the prevalence of chronic pain in the population .
Although certain risk factors can identify individuals who are most likely to develop chronic pain , few interventions to prevent chronic pain have been identified .
To facilitate the identification of preventive interventions , an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain .
We present general design considerations for prevention trials in population s that are at relatively high risk for developing chronic pain .