Pain physician
-
The actions and regulations of the Food and Drug Administration (FDA) are crucial to the entire population of the U. S., specifically the public who take a multitude of drugs and providers who prescribe drugs and devices. Further, the FDA is relevant to investors, specifically in regards to biotech and pharmaceutical companies involved in developing new drugs. ⋯ In fact, the study submitted to the FDA showed a 50% pain improvement in only 48% of the patients in the treatment group and 21% of the patients in the placebo group at 85 day follow-up. This is a statistically significant result but its clinical relevance is unknown. The FDA approval decision occurring against the backdrop of the advisory panel recommendation is concerning and may result in serious consequences in the future.
-
Randomized Controlled Trial Multicenter Study Comparative Study
Tapentadol prolonged release for managing moderate to severe, chronic malignant tumor-related pain.
Tapentadol prolonged release (PR) is effective and well tolerated for chronic osteoarthritis, low back, and diabetic peripheral neuropathic pain. ⋯ Results obtained during maintenance indicate that tapentadol PR (100-250 mg bid) is effective compared with placebo for managing moderate to severe chronic malignant tumor-related pain. Based on results obtained during titration, tapentadol PR provides comparable efficacy to that of morphine sulfate CR (40-100 mg bid), but is associated with better gastrointestinal tolerability.
-
Randomized Controlled Trial Comparative Study
Transforaminal versus parasagittal interlaminar epidural steroid injection in low back pain with radicular pain: a randomized, double-blind, active-control trial.
Epidural injections are the most common minimally invasive intervention used to manage low back pain with lumbosacral radicular pain. It can be delivered through either transforaminal (TF), interlaminar, or caudal approaches. The TF approach is considered more efficacious than the interlaminar approach probably because of ventral epidural spread. However, catastrophic complications reported with the TF approach have raised concerns regarding its use. These concerns regarding the safety of the TF approach lead to the search for a technically better route with lesser complications with drug delivery into the ventral epidural space. The parasagittal interlaminar (PIL) route is reported to have good ventral epidural spread. However, there is a paucity of literature comparing the effectiveness of PIL with TF. ⋯ Epidural injection delivered through the PIL approach is equivalent in achieving effective pain relief and functional improvement to the TF approach for the management of low back pain with lumbosacral radicular pain. The PIL approach can be considered a suitable alternative to the TF approach for its equivalent effectiveness, probable better safety profile, and technical ease.
-
Review Case Reports
Epidural steroid warning controversy still dogging FDA.
On April 23, 2014, the Food and Drug Administration (FDA) issued a letter of warning that injection of corticosteroids into the epidural space of the spine may result in rare, but serious adverse events, including "loss of vision, stroke, paralysis, and death." The advisory also advocated that patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments. In addition, the FDA stated that the effectiveness and safety of the corticosteroids for epidural use have not been established, and the FDA has not approved corticosteroids for such use. To raise awareness of the risks of epidural corticosteroid injections in the medical community, the FDA's Safe Use Initiative convened a panel of experts including pain management experts to help define the techniques for such injections with the aim of reducing preventable harm. ⋯ The results of this review show the efficacy of epidural injections, with or without steroids, in a multitude of spinal ailments utilizing caudal, cervical, thoracic, and lumbar interlaminar approaches as well as lumbar transforaminal epidural injections. The evidence also shows the superiority of steroids in managing lumbar disc herniation utilizing caudal and lumbar interlaminar approaches without any significant difference as compared to transforaminal approaches, either with local anesthetic alone or local anesthetic and steroids combined. In conclusion, the authors request that the FDA modify the warning based on the evidence.
-
Randomized Controlled Trial
Transforaminal epidural injections in chronic lumbar disc herniation: a randomized, double-blind, active-control trial.
The estimated prevalence of lumbar radiculopathy has been described as 9.8 per 1,000 cases of low back pain. There are various surgical and nonsurgical modalities for treating lumbar disc herniation or radicular pain, including epidural injections. Epidural injection administration routes include transforaminal, interlaminar, and caudal approaches. The transforaminal approach requires the smallest volume to reach the primary site of pathology. Systematic reviews have yielded highly variable results, but a recent systematic review showed no significant difference among the 3 approaches. ⋯ Transforaminal epidural injections of local anesthetic with or without steroids might be an effective therapy for patients with disc herniation or radiculitis. The present evidence illustrates the lack of superiority of steroids compared with local anesthetic at 2-year follow-up.