Pain
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Randomized Controlled Trial Multicenter Study
Contributions of change in clinical status parameters to Patient Global Impression of Change (PGIC) scores among persons with fibromyalgia treated with milnacipran.
Clinical trials on the treatment of pain syndromes have adopted Patient Global Impression of Change (PGIC) as a primary outcome. However, little is known about how change in clinical status influences these ratings. The present study examined relationships between changes in pain, depressed mood, physical functioning, vitality, sleep disturbance, cognitive complaints, and PGIC ratings among 1260 participants with fibromyalgia (FM) who completed one of two trials examining the safety and efficacy of milnacipran. ⋯ Among responders, improvements in pain were significantly associated with better PGIC ratings, along with improvements in vitality, sleep, physical function, and cognitive complaints. These findings underscore the complexity of global ratings in FM patients, and suggest the association between clinical status and PGIC ratings varies as a function of perceived treatment response. Several domains were associated with PGIC ratings, highlighting the need to assess multiple outcomes in clinical trials of treatments for FM.
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Randomized Controlled Trial
A randomized placebo-controlled trial of intradiscal methylene blue injection for the treatment of chronic discogenic low back pain.
A preliminary report of clinical study revealed that chronic discogenic low back pain could be treated by intradiscal methylene blue (MB) injection. We investigated the effect of intradiscal MB injection for the treatment of chronic discogenic low back pain in a randomized placebo-controlled trial. We recruited 136 patients who were found potentially eligible after clinical examination and 72 became eligible after discography. ⋯ The patients in MB injection group showed a mean reduction in pain measured by NRS of 52.50, a mean reduction in Oswestry disability scores of 35.58, and satisfaction rates of 91.6%, compared with 0.70%, 1.68%, and 14.3%, respectively, in placebo treatment group (p<0.001, p<0.001, and p<0.001, respectively). No adverse effects or complications were found in the group of patients treated with intradiscal MB injection. The current clinical trial indicates that the injection of methylene blue into the painful disc is a safe, effective and minimally invasive method for the treatment of intractable and incapacitating discogenic low back pain.
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Randomized Controlled Trial
Low-dose amitriptyline for treatment of persistent arm pain due to repetitive use.
Amitriptyline is sometimes used to treat arm pain related to repetitive use, but rigorous evidence of its benefit is lacking. This randomized controlled trial investigated whether amitriptyline provided greater pain relief or improved arm function than a placebo pill in adults with arm pain associated with repetitive use that had persisted for at least 3 months. Participants (N=118) were randomly assigned to receive 25mg of amitriptyline or a placebo pill for 6 weeks. ⋯ The most frequent side effect was drowsiness. In conclusion, this study found that low-dose amitriptyline did not significantly decrease arm pain among these participants but did significantly improve arm function and well being. Future research is needed to explore the effects of higher doses and longer duration of treatment.
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Randomized Controlled Trial Clinical Trial
Neuronal correlates in the modulation of placebo analgesia in experimentally-induced esophageal pain: a 3T-fMRI study.
Visceral pain/discomfort is the cardinal complaints and treatment targets for functional gastrointestinal disorders (FGID). However, effective treatment for such pain is limited and often associated with high placebo effects. The mechanisms of placebo effects in visceral pain are unclear. ⋯ PAS cannot predict the placebo effect in visceral pain. In conclusion, pronounced placebo analgesia was coupled with prominent changes of brain activity in visceral pain matrix, which are thus likely involved in high placebo efficacy during the treatment of visceral pain in FGID. VLPFC activation during the anticipation of placebo analgesia suggests top-down control in the modulation of pain experience.
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Randomized Controlled Trial Clinical Trial
High-frequency, high-intensity transcutaneous electrical nerve stimulation as treatment of pain after surgical abortion.
The aim of the study was to compare the pain-relieving effect and the time spent in the recovery ward after treatment with high-frequency, high-intensity transcutaneous electrical nerve stimulation (TENS) or intravenous (IV) conventional pharmacological treatment after surgical abortion. Two-hundred women who underwent surgical abortion and postoperatively reported a visual analogue scale (VAS) pain score3 were included. The patients were randomised to TENS or conventional pharmacological treatment for their postoperative pain. ⋯ The number of patients who needed additional analgesics in the recovery ward was comparable in both groups, as was the reported VAS pain score upon leaving the hospital (TENS=2.0 vs. conventional pharmacological treatment=1.8, NS). These results suggest that the pain-relieving effect of TENS seems to be comparable to conventional pharmacological treatment with IV opioids. Hence, TENS may be a suitable alternative to conventional pain management with IV opioids after surgical abortion.