Articles: pain-measurement.
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Randomized Controlled Trial Multicenter Study
Efficacy of naproxen in patients with sciatica: multicentre, randomized, double-blind, placebo-controlled trial.
This trial assessed the efficacy of naproxen in patients with sciatica in outpatient clinics across 4 Norwegian hospitals. A total of 123 adults with radiating pain below the knee (≥4 on a 0-10 numeric rating scale) and signs consistent with nerve root involvement were included. Participants were randomized to receive either naproxen 500 mg or a placebo twice daily for 10 days. ⋯ No differences were found for sciatica bothersomeness or consumption of rescue medication or opioids. Participants in the naproxen group exhibited an adjusted odds ratio of 4.7 (95% CI 1.3-16.2) for improvement by 1 level on the global perceived change scale. In conclusion, naproxen treatment showed small, likely clinically unimportant benefits compared with placebo in patients with moderate-to-severe sciatica.
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Randomized Controlled Trial Multicenter Study Comparative Study
High-frequency, high-intensity TENS compared to standard treatment with opioids for postoperative pain relief after laparoscopic cholecystectomy: A multicentre randomized controlled trial.
Adverse effects of opioids could prolong the duration of stay in the post-anaesthesia care unit (PACU). This study aimed to assess time in the PACU and the pain-relieving effect of high-frequency, high-intensity transcutaneous electrical nerve stimulation (HFHI TENS) versus standard treatment with intravenous (IV) opioids. ⋯ In this multicentre, RCT time in the PACU and the pain-relieving effect of HFHI TENS was compared to standard treatment with IV opioids. There were no differences between the groups regarding time in the PACU, time to pain relief and side effects but opioid consumption in the HFHI TENS group was significantly lower. Both groups reported high satisfaction with pain treatment and care. In summary, HFHI TENS should be considered a safe, fast-onsetting, opioid-sparing option for postoperative pain relief.
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Establishing clinically meaningful changes in pain experiences remains important for clinical trials of chronic pain treatments. Regulatory guidance and pain measurement initiatives have recommended including patient-reported global assessment measures (eg, Patient-Global Impression of Change [PGIC]) to aid interpretation of within-patient differences in domain-specific clinical trial outcomes (eg, pain intensity). The objectives of this systematic review were to determine the frequency of global assessment measures inclusion, types of measures, domains assessed, number and types of response options, and how measures were analyzed. ⋯ Response options and reference periods even differed within the PGIC. Global assessment measures were most commonly analyzed as continuous variables (n = 24; 46.2%) or as dichotomous variables with positive categories combined to calculate the proportion of participants with a positive response to treatment (n = 18; 34.6%). This review highlights the substantial work necessary to clarify measurement and use of patient global assessment in chronic pain trials and provides short- and long-term considerations for measure selection, reporting and analysis, and measure development.
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Randomized Controlled Trial
Mean of Daily Versus Single Week Recall-Based Pain Quality Assessments in Neuropathic Pain Trials: Implications for Assay Sensitivity.
Patients with neuropathic pain often present with variable pain and nonpainful sensory qualities that could serve as outcomes in randomized clinical trials (RCTs). This study aimed to investigate the within-participant variability in the severity of these sensory qualities and whether the means of 7 daily pain quality assessments provide better assay sensitivity (ie, more sensitivity to treatment effects) than single-week recall-based assessments. This secondary analysis used data from an RCT of transcutaneous electrical nerve stimulation for chemotherapy-induced peripheral neuropathy (N = 142). ⋯ Compared with single-week recall-based assessments of pain qualities, the mean of daily assessments may improve RCT assay sensitivity when used to define entry criteria and assess outcomes. PERSPECTIVE: This study suggests that means of daily pain quality assessments may improve assay sensitivity when used to define entry criteria and assess outcomes in clinical trials. This work may inform design of future clinical trials evaluating the intensity of different pain qualities.
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Observational Study
Predicting Responses to Interventional Pain Management Techniques for Chronic Low Back Pain: A Single-Center Observational Study (PReTi-Back Study).
Exploring factors linked to the outcomes of certain interventional pain management techniques may optimize the selection of candidates for those procedures. Our hypothesis is that factors that influence responses to interventional therapies for chronic low back pain (CLBP) can be identified by analyzing a prospective cohort. ⋯ Patients satisfied with previously performed interventional therapies or who exhibit findings of radicular compression or listhesis on imaging show approximately twice the likelihood of experiencing a positive response to short-term IMPT than do patients without those characteristics. Patients who are obese or have PSPS-2 exhibit approximately a 50% lower likelihood of short-term response than do patients without these conditions.