Pain
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Randomized Controlled Trial
Changes in morphine analgesia and side effects during daily subcutaneous administration in healthy volunteers.
Tolerance to the anti-nociceptive effects of opioids develops rapidly in animals. In contrast, humans with chronic pain show little or no loss of pain relief in prospective opioid trials of 4-8 weeks duration. Employing the Brief Thermal Sensitization model to induce transient cutaneous secondary hyperalgesia, we tested the hypothesis that opioid analgesic tolerance would develop rapidly. ⋯ During 4 days of twice-daily injections, the decline in anti-hyperalgesic effects of morphine did not reach statistical significance (p=0.06) compared to placebo. Morphine side effects did not correlate with anti-hyperalgesic effects and withdrawal symptoms did not emerge. As 4 days is the threshold for demonstrating analgesic tolerance to twice-daily morphine in animal models, a longer period of opioid exposure in healthy volunteers might be needed to detect analgesic tolerance.
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Randomized Controlled Trial Multicenter Study
Laser acupuncture in children with headache: a double-blind, randomized, bicenter, placebo-controlled trial.
To investigate whether laser acupuncture is efficacious in children with headache and if active laser treatment is superior to placebo laser treatment in a prospective, randomized, double-blind, placebo-controlled trial of low level laser acupuncture in 43 children (mean age (SD) 12.3 (+/-2.6) years) with headache (either migraine (22 patients) or tension type headache (21 patients)). Patients were randomized to receive a course of 4 treatments over 4 weeks with either active or placebo laser. The treatment was highly individualised based on criteria of Traditional Chinese medicine (TCM). ⋯ The mean number of headaches per month decreased significantly by 6.4 days in the treated group (p<0.001) and by 1.0 days in the placebo group (p=0.22). Secondary outcome measures headache severity and monthly hours with headache decreased as well significantly at all time points compared to baseline (p<0.001) and were as well significantly lower than those of the placebo group at all time points (p<0.001). We conclude that laser acupuncture can provide a significant benefit for children with headache with active laser treatment being clearly more effective than placebo laser treatment.
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Randomized Controlled Trial
Effects of intra-articular ketamine on pain and somatosensory function in temporomandibular joint arthralgia patients.
Recent studies have hypothesized that peripheral glutamate receptors could be implicated in deep craniofacial pain conditions. In this study 18 temporomandibular joint (TMJ) arthralgia patients received intra-articular injections of the N-methyl-D-aspartate (NMDA) receptor antagonist, ketamine, or normal saline to study in a cross-over, double-blinded, placebo-controlled manner the effect on TMJ pain and somatosensory function. Spontaneous pain and pain on jaw function was scored by patients on 0-10 cm visual analogue scale (VAS) for up to 24h. ⋯ There were no significant effects of intra-articular ketamine over time on spontaneous VAS pain measures (ANOVA: P=0.532), pain on jaw opening (ANOVA: P=0.384), or any of the somatosensory measures (ANOVA: P>0.188). The poor effect of ketamine could be due to involvement of non-NMDA receptors in the pain mechanism and/or ongoing pain and central sensitization independent of peripheral nociceptive input. In conclusion, there appears to be no rationale to use intra-articular ketamine injections in TMJ arthralgia patients, and peripheral NMDA receptors may play a minor role in the pathophysiology of this disorder.
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Randomized Controlled Trial Multicenter Study
Alvimopan, a peripherally acting mu-opioid receptor (PAM-OR) antagonist for the treatment of opioid-induced bowel dysfunction: results from a randomized, double-blind, placebo-controlled, dose-finding study in subjects taking opioids for chronic non-cancer pain.
Our objective was to investigate the efficacy and safety of alvimopan, a peripherally acting mu-opioid receptor (PAM-OR) antagonist, in subjects with non-cancer pain and opioid-induced bowel dysfunction (OBD), and to identify at least one treatment regimen that improves OBD. Following a 2-week baseline period, 522 subjects reporting <3 spontaneous bowel movements (SBMs)/week (with >or=25% accompanied by a sensation of incomplete evacuation, straining, or lumpy hard stools), requiring analgesia equivalent to >or=30 mg oral morphine/day were randomized to alvimopan 0.5mg twice daily (BID), 1mg once daily (QD), 1mg BID, or placebo for 6 weeks. Compared with placebo, there was a statistically and clinically significant increase in mean weekly SBM frequency over the initial 3 weeks of treatment (primary endpoint) with alvimopan 0.5mg BID (+1.71 mean SBMs/week), alvimopan 1mg QD (+1.64) and alvimopan 1mg BID (+2.52); P<0.001 for all comparisons. ⋯ The alvimopan 0.5mg BID regimen demonstrated the best benefit-to-risk profile for managing OBD with alvimopan in this study population, with a side effect profile similar to that of placebo. There was no evidence of opioid analgesia antagonism. Competitive peripheral antagonism of opioids with alvimopan can restore GI function and relieve OBD without compromising analgesia.
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Randomized Controlled Trial Comparative Study
Effectiveness of leech therapy in women with symptomatic arthrosis of the first carpometacarpal joint: a randomized controlled trial.
Leech therapy has been shown to be effective for symptomatic treatment of osteoarthritis of the knee. We aimed to investigate the effectiveness of leech therapy in another type of osteoarthritis, osteoarthritis of the first carpometacarpal joint (thumb saddle joint). Thirty-two women with symptomatic painful osteoarthritis of the first carpometacarpal joint and who scored>40 mm on a 100mm VAS pain scale were randomized to a single treatment with 2-3 locally applied leeches (leech group) or a 30-day course with topical diclofenac twice a day. ⋯ Results were not affected by outcome expectation or consumption of analgetics. A single course of leech therapy is effective in relieving pain, improving disability and QoL for at least 2 months. The potential of leech therapy for treatment of arthritic pain and underlying mechanisms should be further investigated.