The journal of pain : official journal of the American Pain Society
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Randomized Controlled Trial Multicenter Study
Physician characteristics and variation in treatment outcomes: are better qualified and experienced physicians more successful in treating patients with chronic pain with acupuncture?
The aim of this paper was to quantify the influence of the physician's training and experience in the field of acupuncture on the outcome in patients with chronic pain. Patients visiting their physician because of chronic low back pain, headache, pain due to osteoarthritis of the knee or hip, or neck pain, were included in 4 multicenter, randomized, controlled studies. All patients received routine care; patients in the acupuncture groups received additional acupuncture treatment (on average 10 sessions). The data was pooled, and the 3-month change from baseline of the SF-36 bodily pain subscale as the main outcome defined. A total of 9,990 patients (mean age 49.6 +/- 13.6 years, 68% female) treated by 2,781 physicians (mean age 46.3 +/- 7 years, 37% female) were analyzed. The physicians had 7.3 +/- 5.2 (mean +/- sd) years of experience in acupuncture and their mean duration of formal acupuncture training had been 287 +/- 321 hours. The outcome was markedly improved in the acupuncture group. We identified only 1 physician characteristic with a significant influence on the outcome: Internists performed better (odds ratio OR = 1.49, confidence interval CI: 1.01;2.18; P = .043); orthopedists worse (OR = .79, CI: .62;1; P = .043) than the average physician. Neither the duration of training nor the duration of experience had any impact on the extent of the acupuncture effect. ⋯ In this analysis, physician characteristics such as training did not influence patients' outcome after acupuncture, suggesting that formal training parameters have only a limited influence on treatment effect. Other skills such as the therapeutic relationship, which are difficult to measure, may probably play a more important role and should be taken into consideration.
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Randomized Controlled Trial Multicenter Study
ALO-01 (morphine sulfate and naltrexone hydrochloride) extended-release capsules in the treatment of chronic pain of osteoarthritis of the hip or knee: pharmacokinetics, efficacy, and safety.
ALO-01 (EMBEDA [morphine sulfate and naltrexone hydrochloride] extended-release capsules [King Pharmaceuticals, Inc, Bridgewater, NJ]), indicated for chronic moderate-to-severe pain, is designed to release naltrexone upon tampering (eg, by crushing), reducing morphine-induced subjective effects. This multicenter, randomized, double-blind, crossover study assessed pharmacokinetics, efficacy, and safety of ALO-01 and compared them with extended-release morphine sulfate (ERMS, KADIAN [morphine sulfate extended-release] capsules [Actavis US, Morristown, NJ]) in adults (N = 113) with osteoarthritis pain. Study periods included washout until pain flare (intensity > or =5, 0 to 10; 0 = no pain, 10 = worst pain); dose titration with ERMS (20 to 160mg BID); and randomization to 2 (crossover) 14-day treatment periods with ERMS or ALO-01, separated by 7 days of open-label ERMS. Assessments included pharmacokinetics (morphine, naltrexone), pain scores (0 to 10), Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; Patient Global Assessment of Medication (1 to 5; poor to excellent). Mean score at pain flare was 7.1. Morphine exposure from both formulations at steady state was similar. Plasma naltrexone concentrations were below limit-of-quantification for most patients and, when present, did not impact pain scores. During treatment, mean pain intensity (day 14: ERMS, 2.4; ALO-01, 2.3, P = .31), WOMAC change-from-baseline (mean pain, physical function, composite scores), and adverse event frequency were similar. ALO-01 and ERMS provided similar relief of osteoarthritis pain. ⋯ We present data demonstrating that ALO-01 has steady-state morphine exposure, efficacy, and safety similar to marketed ERMS capsules. Results highlight the potential for morphine in ALO-01 to manage moderate-to-severe osteoarthritis pain, while the sequestered naltrexone does not interfere with efficacy.
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Randomized Controlled Trial Multicenter Study
Feasibility study of Transcutaneous Electrical Nerve Stimulation (TENS) for cancer bone pain.
This multicenter study assessed the feasibility of conducting a phase III trial of transcutaneous electrical nerve stimulation (TENS) in patients with cancer bone pain recruited from palliative care services. Eligible patients received active and placebo TENS for 1 hour at site of pain in a randomized crossover design; median interval between applications 3 days. Responses assessed at 30 and 60 minutes included numerical and verbal ratings of pain at rest and on movement, and pain relief. Recruitment, tolerability, adverse events, and effectiveness of blinding were also evaluated. Twenty-four patients were randomised and 19 completed both applications. The intervention was well tolerated. Five patients withdrew: 3 due to deteriorating performance status, and 2 due to increased pain (1 each following active and placebo TENS). Confidence interval estimation around the differences in outcomes between active and placebo TENS suggests that TENS has the potential to decrease pain on movement more than pain on rest. Nine patients did not consider that a placebo was used; the remaining 10 correctly identified placebo TENS. Feasibility studies are important in palliative care prior to undertaking clinical trials. Our findings suggest that further work is required on recruitment strategies and refining the control arm before evaluating TENS in cancer bone pain. ⋯ Cancer bone pain is common and severe, and partly mediated by hyperexcitability. Animal studies suggest that Transcutaneous Electrical Nerve Stimulation can reduce hyperalgesia. This study examined the feasibility of evaluating TENS in patients with cancer bone pain in order to optimize methods before a phase III trial.
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Randomized Controlled Trial Multicenter Study
Predictors of long-term opioid use among patients with painful lumbar spine conditions.
Our objective was to assess predictors of self-reported opioid use among patients with back pain due to lumbar disc herniation or spinal stenosis. Data were from the Spine Patient Outcomes Research Trial (SPORT), a multi-site observational study and randomized trial. We examined characteristics shown or hypothesized to be associated with opioid use. Using generalized estimating equations, we modeled associations of each potential predictor with opioid use at 12 and 24 months. At baseline, 42% of participants reported opioid use. Of these participants, 25% reported continued use at 12 months and 21% reported use at 24 months. In adjusted models, smoking (RR = 1.9, P < .001 at 12 months; RR = 1.5, P = .043 at 24 months) and nonsurgical treatment (RR = 1.7, P < .001 at 12 months; RR = 1.8, P = .003 at 24 months) predicted long-term opioid continuation. Among participants not using opioids at baseline, incident use was reported by 8% at 12 months and 7% at 24 months. We found no significant predictors of incident use at 12 or 24 months in the main models. In conclusion, nonsurgical treatment and smoking independently predicted long-term continued opioid use. To our knowledge, this is the first longitudinal study to assess predictors of long-term and incident opioid use among patients with lumbar spine conditions. ⋯ This longitudinal study of patients with disc herniation or spinal stenosis found that nonsurgical treatment and smoking predicted long-term self-reported opioid use. The greater risk of opioid continuation with nonsurgical therapy may be helpful in decision-making about treatment. The relationship between opioid use, smoking, and other substance use deserves further study.
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Multicenter Study Clinical Trial
A multicenter, open-label, exploratory dose-ranging trial of intranasal hydromorphone for managing acute pain from traumatic injury.
We conducted a prospective multicenter, open-label, escalating dose-range trial to compare, across patients, single intranasal doses (2, 4, 6, 8, and 10 mg) of hydromorphone HCl in the treatment of acute trauma pain The main outcome measure of pain-intensity reduction was derived from serial Numerical Pain-Rating Scores and calculated as the summed pain-intensity difference over 3 hours (SPID 3). Nasal examinations, vital signs, and adverse events were reported as safety outcomes. The mean decrease in pain intensity from baseline to 30 minutes was 39 to 44% for the 4-, 6-, 8- and 10-mg doses (n = 19, 33, 28, and 19 per group) and only 24% reduction for the 2-mg dose (n = 14). SPID 3 for the 2-mg dose was 40 to 50% below all other doses. There were no clinically meaningful changes in vital signs or nasal examinations. Adverse events (nausea, vomiting, pruritus, oxygen desaturation, bad taste, dizziness) were of mild to moderate intensity, increased with dose, and expected, based on route of administration and opioid pharmacology. Intranasal hydromorphone provides a component of rapid pain relief in the care of emergency department patients suffering from acute trauma pain. ⋯ This article presents a pilot dose-ranging study of intranasally administered hydromorphone, administered in the emergency department to patients suffering from acute trauma pain. This study demonstrates research success in this setting and noninjection-based delivery and certain doses of intranasal hydromorphone may be effective in treating acute trauma pain.