Prevention of Opioid-Induced Nausea and Vomiting During Treatment of Moderate to Severe Acute Pain: A Randomized Placebo-Controlled Trial Comparing CL-108 (Hydrocodone 7.5 mg/Acetaminophen 325 mg/Rapid-Release, Low-Dose Promethazine 12.5 mg) with Conventional Hydrocodone 7.5 mg/Acetaminophen 325 mg.

OBJECTIVES: To evaluate the prevention of opioid-induced nausea and vomiting (OINV) and the relief of moderate to severe acute pain by CL-108, a novel drug combining a low-dose antiemetic (rapid-release promethazine 12.5 mg) with hydrocodone 7.5 mg/acetaminophen 325 mg (HC/APAP) was used. METHODS: This was a multicenter, randomized, double-blind, placebo- and active-controlled multidose study. After surgical extraction of two or more impacted third molar teeth (including at least one mandibular impaction), 466 patients with moderate to severe pain (measured on a categorical pain intensity scale [PI-CAT]) were randomized to CL-108, HC/APAP, or placebo. Over the next 24 hours, patients used the PI-CAT to assess pain at regular intervals whereas nausea, vomiting, and other opioid-related side effects were also assessed prospectively. Study medications were taken every four to six hours as needed; supplemental rescue analgesic and antiemetic medications were permitted. Co-primary end points were the incidence of OINV and the time-weighted sum of pain intensity differences over 24 hours (SPID24). RESULTS: Relative to HC/APAP treatment alone, CL-108 treatment reduced OINV by 64% (P < 0.001). Treatment with CL-108 significantly reduced pain intensity compared with placebo (SPID24 = 16.2 vs 3.5, P < 0.001). There were no unexpected or serious adverse events. CONCLUSIONS: CL-108 is a safe and effective combination analgesic/antiemetic for the prevention of OINV during treatment of moderate to severe acute pain.

Test-retest reliability of the Tekscan® F-Scan® 7 in-shoe plantar pressure system during treadmill walking in healthy recreationally active individuals.

In-shoe plantar pressure systems are commonly used in clinical and research settings to assess foot function during functional tasks. Recently, Tekscan® has updated their F-Scan® in-shoe plantar pressure system; however, this system's test-retest reliability has not been established. Therefore, the purpose of this study was to determine the test-retest reliability of the F-Scan® 7 system in recreationally active individuals during treadmill walking. Seventeen healthy adults completed 2 sessions of treadmill walking. For each session, participants were fitted for shoes and pressure insoles and walked on a treadmill at a self-selected pace for 30 s. Following the sessions, the test-retest reliability peak pressure, pressure time integral, average pressure and pressure contact area over 4 regions of the foot (heel, mid-foot, forefoot and toes) was assessed by calculating intraclass coefficients (ICC 2,k) and coefficient of variation percentage (CoV%). Pressure contact area consistently had the highest ICCs and lowest CoV% (ICCs: 0.91-0.98; CoV%: 2.7-7.8%). Whereas, the forefoot and toe regions had the highest ICCs for all 4 measures (ICCs: 0.83-0.98; CoV%: 3.1-13.4%). During treadmill walking in healthy recreationally active individuals, the reliability of the new Tekscan F-Scan® ranged from poor to high and was dependent on the measure and region of the foot.

WITHDRAWN: (440) Opioid-Induced Nausea and Vomiting (OINV) in Post-Operative Patients: A Comparison of CL-108 to Hydrocodone 7.5 mg/Acetaminophen 325 mg.

The Publisher regrets that this abstract is an accidental duplication of abstract (436), also published in the 2016 American Pain Society Scientific Meeting abstracts supplement: J Pain 17:S83, 2016, http://dx.doi.org/10.1016/j.jpain.2016.01.413. The duplicate abstract (440) has therefore been withdrawn. The full Elsevier Policy on Article Withdrawal can be found at http://www.elsevier.com/locate/withdrawalpolicy.

Duloxetine versus placebo in patients with chronic low back pain: a 12-week, fixed-dose, randomized, double-blind trial.

UNLABELLED: This randomized, double-blind, placebo-controlled study assessed efficacy and safety of duloxetine in patients with chronic low back pain (CLBP). Adults (n = 401) with a nonneuropathic CLBP and average pain intensity of ≥ 4 on an 11-point numerical scale (Brief Pain Inventory [BPI]) were treated with either duloxetine 60 mg once daily or placebo for 12 weeks. The primary measure was BPI average pain. Secondary endpoints included Patient's Global Impressions of Improvement (PGI-I), Roland Morris Disability Questionnaire (RMDQ-24), BPI-Severity (BPI-S), BPI-Interference (BPI-I), and response rates (either ≥ 30% or ≥ 50% BPI average pain reduction at endpoint). Health outcomes included Short Form-36, European Quality of Life-5 Dimensions, and the Work Productivity and Activity Impairment questionnaire. Safety and tolerability were assessed. Compared with placebo-treated patients, duloxetine-treated patients reported a significantly greater reduction in BPI average pain (P ≤ .001). Similarly, duloxetine-treated patients reported significantly greater improvements in PGI-I, BPI-S, BPI-I, 50% response rates, and some health outcomes. The RMDQ and 30% response rate showed numerical improvements with duloxetine treatment. Significantly more patients in the duloxetine group (15.2%) than patients in the placebo group (5.4%) discontinued because of adverse events (P = .002). Nausea and dry mouth were the most common treatment-emergent adverse events with rates significantly higher in duloxetine-treated patients. PERSPECTIVE: This study provides clinical evidence of the efficacy and safety of duloxetine at a fixed dose of 60 mg once daily in the treatment of chronic low back pain (CLBP). As of December 2009, duloxetine has not received regulatory approval for the treatment of CLBP.

Use of low-frequency electrical stimulation for the treatment of plantar fasciitis.

BACKGROUND: Recent research has discussed the use of low-frequency electrical stimulation to increase blood flow by eliciting muscular contraction in soft tissues. This randomized clinical trial examined the efficacy of low-frequency electrical stimulation combined with stretching exercises and foot orthoses in individuals diagnosed as having plantar fasciitis for less than 6 months. METHODS: Twenty-six participants aged 18 to 65 years diagnosed as having plantar fasciitis were randomly assigned to two treatment groups: a control group receiving only stretching and orthoses and a treatment group receiving low-frequency electrical stimulation in addition to stretching and orthoses. To assess treatment response, a visual analog scale was used to determine first-step morning pain, and changes in daily activity levels were monitored by using a validated outcome measure. All of the participants were assessed before starting treatment, after 4 weeks of treatment, and 3 months after the conclusion of treatment. RESULTS: Participants in the control and experimental groups demonstrated pain reduction and improvements in functional activity levels after 4 weeks and 3 months. CONCLUSIONS: Regardless of whether low-frequency electrical stimulation was used as an intervention, the use of plantar fascia-specific stretching and prefabricated foot orthoses provided short-term (3-month) pain relief and improvement in functional activity levels.