Extended-release tramadol/paracetamol in moderate-to-severe pain: a randomized, placebo-controlled study in patients with acute low back pain

Abstract

Using acute low back pain, a model with a high degree of heterogeneity and intrinsic variability, DDS-06C was superior to placebo on measures of pain intensity and relief, and was well-tolerated.

An Updated Overview of Low Back Pain Management in Primary Care

“…A total of 18 methods for the treatment of acute and chronic LBP were reviewed by the assessment panel [ 2 3 4 10 11 12 13 14 15 16 17 18 19 ]. For acute LBP, several randomized trials and higher-quality systematic reviews found non-steroidal anti-inflammatory dru gs (NSAIDs), acetaminophen (AAP), and paracetamol superior for pain relief ( Table 2 ).…”

DANTE Study: The First Randomized, Double-Blind, Placebo and Active-Controlled, Parallel Arm Group Study Evaluating the Analgesic Efficacy and Safety of Dexketoprofen TrometAmol aNd Tramadol Hydrochloride Oral FixEd Dose Combination on Moderate to Severe Acute Pain in Patients with Acute Low Back Pain—Rationale and Design

“…The main strengths of the DANTE study are the large sample size (larger than previous COX inhibitors and COX inhibitor/opioid combination study cohorts enrolling LBP patients) [33,34,44,45,50], the heterogeneity of the study population, resembling real-life conditions, the use of multiple analgesic and function assessments, and the comprehensive evaluation of patients' perspective, often neglected in previous clinical trials [28,33,34,50]. One limitation of the study is the lack of a treatment arm receiving a COX inhibitor/opioid combination; nevertheless, in a previous acute moderate-tosevere pain model, TRAM/DKP 75/25 mg demonstrated to be more effective than paracetamol/TRAM in the largest study so far performed in acute patients undergoing impacted third molar extraction [42].…”

“…In addition, the variable adherence of clinicians to current recommendations [ 19 – 21 ] may likely stem from the limited treatment guidance they retrieve for everyday clinical practice, with a concerning number of patients remaining at a higher risk of recurrence and chronicity. Overall, current LBP management may benefit from additional clinical evidence, particularly if built upon a rigorous clinical trial design, an evidence-based medication choice, and broader inclusion criteria that may better acknowledge the high degree of heterogeneity and intrinsic variability of LBP [ 50 ]. In addition, the use of a non-surgical clinical pain model and a comprehensive assessment of both patients’ recovery from functional disability and their satisfaction with the prescribed pain medication is also of clinical interest to fully investigate TRAM/DKP efficacy in LBP setting.…”

An Updated Overview of Low Back Pain Management

“…Multiple higher-quality trials, SRs, and numerous clinical guidelines have demonstrated improvement with nonsteroidal anti-inflammatory drugs (NSAIDs) acetaminophen (AAP), and paracetamol for acute LBP [15][16][17][18][19][20][21][22][23][24] (Table 3). Two trials and one clinical guideline reported minimal evidence for carisoprodol, herbal therapy, thiocolchicoside, and tizanidine [6,16,18].…”