Articles: back-pain.
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Randomized Controlled Trial Multicenter Study
Efficacy and Tolerability of Buccal Buprenorphine in Opioid-Experienced Patients With Moderate to Severe Chronic Low Back Pain: Results of a Phase 3, Enriched Enrollment, Randomized Withdrawal Study.
A buccal film of buprenorphine (BBUP) was evaluated for safety and efficacy in a multicenter, double-blind, placebo-controlled, enriched-enrollment, randomized-withdrawal study in opioid-experienced patients (30 to ≤160 mg/d morphine sulfate equivalent) with moderate to severe chronic low back pain taking around-the-clock opioid analgesics. Patients' opioid doses were tapered to ≤30 mg morphine sulfate equivalent before open-label titration with BBUP (range, 150-900 μg every 12 hours). Patients who responded (received adequate analgesia that was generally well tolerated for 14 days) were randomized to receive buprenorphine (n = 254) or placebo (n = 257) buccal film. ⋯ A significantly larger percentage of patients receiving BBUP than placebo had pain reductions ≥30% and ≥50% (P < 0.001 for both). In the double-blind portion of the study, the only adverse event reported more frequently with BBUP than placebo and in ≥5% of patients was vomiting (5.5% vs 2.3%). These findings demonstrate the efficacy and tolerability of BBUP in opioid-experienced patients taking around-the-clock opioid treatment for chronic low back pain.
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OBJECTIVE The relief of leg symptoms by surgical decompression for lumbar stenosis is well supported by the literature. Less is known about the effect on back pain. Some surgeons believe that the relief of back pain should not be an expected outcome of decompression and that substantial back pain may be a contraindication to decompression only; therefore, stabilization may be recommended for patients with substantial preoperative back pain even in the absence of well-accepted indications for stabilization such as spondylolisthesis, scoliosis, or sagittal malalignment. ⋯ The vast majority of discharges (88%) were routine home discharges. At 3 and 12 months postoperatively, there were significant improvements from baseline for back pain (7.62 to 3.19 to 3.66), leg pain (7.23 to 2.85 to 3.07), EQ-5D (0.55 to 0.76 to 0.75), and ODI (49.11 to 27.20 to 26.38). CONCLUSIONS Through the 1st postoperative year, patients with lumbar stenosis-without spondylolisthesis, scoliosis, or sagittal malalignment-and clinically significant back pain improved after decompression-only surgery.
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Clin Neurol Neurosurg · Nov 2016
Multicenter StudyInfluence of age on pain intensity, functional impairment and health-related quality of life before and after surgery for lumbar degenerative disc disease.
Demographic changes will lead to an increase of elderly people in our population and consecutively to a higher prevalence of patients suffering from degenerative disc disease (DDD). The goal of this study was to investigate age-related differences in pain intensity, subjective and objective functional impairment and health-related quality of life (HRQoL) in patients with lumbar DDD. ⋯ The influence of age on subjective and objective measures of pain, functional impairment and HRQoL is limited for patients with LDH and LSS, but suggests an age-dependent increase of functional disability. Younger patients generally showed greater postoperative improvement at six weeks than older patients.
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Randomized Controlled Trial Multicenter Study Comparative Study
A Prospective, Randomized, Multi-Center, Open-Label Clinical Trial Comparing Intradiscal Biacuplasty to Conventional Medical Management for Discogenic Lumbar Back Pain.
This study was a prospective, randomized, crossover, multicenter trial for the evaluation of comparative effectiveness of intradiscal biacuplasty (IDB) versus conventional medical management (CMM) in the treatment of lumbar discogenic pain. ⋯ 2.
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Randomized Controlled Trial Multicenter Study
Six-month, open-label study of hydrocodone extended release formulated with abuse-deterrence technology: Safety, maintenance of analgesia, and abuse potential.
To evaluate long-term safety, maintenance of analgesia, and aberrant drug-related behaviors of hydrocodone extended release (ER) formulated with CIMA® Abuse-Deterrence Technology. ⋯ Abuse-deterrent hydrocodone ER was generally well tolerated in patients with chronic low back pain, maintained efficacy, and was associated with low rates of loss and diversion.