Pain
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Randomized Controlled Trial Multicenter Study
Prevention of medication overuse in patients with migraine.
This multi-center study compared the therapeutic effect of a cognitive-behavioral minimal contact program (MCT) to the effect of a brochure (bibliotherapy) for the prevention of medication overuse headache (MOH) in migraine patients. Seven German headache centers recruited 182 migraine patients with high triptan or analgesic intake frequency. Patients were randomly allocated to either the MCT-group, receiving both an MCT program and an educational brochure or to the biblio-group receiving only the brochure. ⋯ Psychological improvements remained stable in both groups at short- and long-term follow-up. During the study, none of the patients developed an MOH. MCT- and bibliotherapy are useful in migraine patients to prevent medication overuse headache or the transition of episodic to chronic headache.
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Randomized Controlled Trial Multicenter Study Clinical Trial
German Randomized Acupuncture Trial for chronic shoulder pain (GRASP) - a pragmatic, controlled, patient-blinded, multi-centre trial in an outpatient care environment.
The German Randomized Acupuncture Trial for chronic shoulder pain (GRASP) comprised 424 outpatients with chronic shoulder pain (CSP) > or =6 weeks and an average pain score of VAS > or =50 mm, who were randomly assigned to receive Chinese acupuncture (verum), sham acupuncture (sham) or conventional conservative orthopaedic treatment (COT). The patients were blinded to the type of acupuncture and treated by 31 office-based orthopaedists trained in acupuncture; all received 15 treatments over 6 weeks. The 50% responder rate for pain was measured on a VAS 3 months after the end of treatment (primary endpoint) and directly after the end of the treatment (secondary endpoint). ⋯ In the ITT (n=424) analysis, percentages of responders for the primary endpoint were verum 65% (95% CI 56-74%) (n=100), sham 24% (95% CI 9-39%) (n=32), and COT 37% (95% CI 24-50%) (n=50); secondary endpoint: verum 68% (95% CI 58-77%) (n=92), sham 40% (95% CI 27-53%) (n=53), and COT 28% (95% CI 14-42%) (n=38). The results are significant for verum over sham and verum over COT (p<0.01) for both the primary and secondary endpoints. The PPP analysis of the primary (n=308) and secondary endpoints (n=360) yields similar responder results for verum over sham and verum over COT (p<0.01). Descriptive statistics showed greater improvement of shoulder mobility (abduction and arm-above-head test) for the verum group versus the control group immediately after treatment and after 3 months. The trial indicates that Chinese acupuncture is an effective alternative to conventional orthopaedic treatment for CSP.
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Randomized Controlled Trial Multicenter Study
A multicenter, randomized, triple-masked, placebo-controlled trial of the effect of ambulatory continuous femoral nerve blocks on discharge-readiness following total knee arthroplasty in patients on general orthopaedic wards.
A continuous femoral nerve block (cFNB) involves the percutaneous insertion of a catheter adjacent to the femoral nerve, followed by a local anesthetic infusion, improving analgesia following total knee arthroplasty (TKA). Portable infusion pumps allow infusion continuation following hospital discharge, raising the possibility of decreasing hospitalization duration. We therefore used a multicenter, randomized, triple-masked, placebo-controlled study design to test the primary hypothesis that a 4-day ambulatory cFNB decreases the time until each of three predefined readiness-for-discharge criteria (adequate analgesia, independence from intravenous opioids, and ambulation 30m) are met following TKA compared with an overnight inpatient-only cFNB. ⋯ Patients who were given 4 days of perineural ropivacaine attained all three criteria in a median (25th-75th percentiles) of 47 (29-69)h, compared with 62 (45-79)h for those of the control group (Estimated ratio=0.80, 95% confidence interval: 0.66-1.00; p=0.028). Compared with controls, patients randomized to ropivacaine met the discharge criterion for analgesia in 20 (0-38) versus 38 (15-64)h (p=0.009), and intravenous opioid independence in 21 (0-37) versus 33 (11-50)h (p=0.061). We conclude that a 4-day ambulatory cFNB decreases the time to reach three important discharge criteria by an estimated 20% following TKA compared with an overnight cFNB, primarily by improving analgesia.
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Randomized Controlled Trial Multicenter Study
How do changes in pain severity levels correspond to changes in health status and function in patients with painful diabetic peripheral neuropathy?
The current analysis compares changes in pain with changes in function and health status in individuals with painful diabetic peripheral neuropathy (DPN). The post hoc analysis is based on a 12week, multinational, placebo-controlled trial of pregabalin in which 401 patients were randomized to treatment. Study measures included the Brief Pain Inventory short-form (BPI-sf), EQ-5D and other patient-reported outcomes. ⋯ Similarly, a reduction in the NRS of 30% and 50% corresponded to a 3-point and a 5-point improvement in the PII, respectively. Changes in pain were also associated with changes in health status. Results suggest that patients whose pain is not reduced to a mild level of severity can still experience clinically important changes in function and health status.
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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.