Pain
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Randomized Controlled Trial Multicenter Study
Efficacy and safety of eliapixant in diabetic neuropathic pain and prediction of placebo responders with an exploratory novel algorithm: results from the randomized controlled phase 2a PUCCINI study.
Phase 2a of the PUCCINI study was a placebo-controlled, double-blind, parallel-group, multicenter, proof-of-concept study evaluating the efficacy and safety of the selective P2X3 antagonist eliapixant in patients with diabetic neuropathic pain (DNP) ( ClinicalTrials.gov NCT04641273). Adults with type 1 or type 2 diabetes mellitus with painful distal symmetric sensorimotor neuropathy of >6 months' duration and neuropathic pain were enrolled and randomized 1:1 to 150 mg oral eliapixant twice daily or placebo for 8 weeks. The primary endpoint was change from baseline in weekly mean 24-hour average pain intensity score at week 8. ⋯ As the primary endpoint was not met, the PUCCINI study was terminated after completion of phase 2a and did not proceed to phase 2b. In conclusion, selective P2X3 antagonism in patients with DNP did not translate to any relevant improvement in different pain intensity outcomes compared with placebo. Funding: Bayer AG.
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Randomized Controlled Trial
Education can reassure people with rotator cuff-related shoulder pain: a 3-arm, randomised, online experiment.
We aimed to investigate the immediate effect of best practice education (with and without pain science messages) and structure-focused education on reassurance among people with rotator cuff-related shoulder pain. We conducted a 3-arm, parallel-group, randomised experiment. People with rotator cuff-related shoulder pain were randomised (1:1:1) to (1) best practice education (highlights that most shoulder pain is not serious or a good indicator of tissue damage and recommends simple self-management strategies); (2) best practice education plus pain science messages (which attempt to improve understanding of pain); and (3) structure-focused education (highlighting that structural changes are responsible for pain and should be targeted with treatment). ⋯ Adding pain science messages to best practice education slightly increased both measures of reassurance (0.2, 95% CI 0.0-0.4). Clinicians treating patients with rotator cuff-related shoulder pain should highlight that most shoulder pain is not serious or a good indicator of tissue damage and recommend simple self-management strategies. The benefit of adding pain science messages is small.
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Randomized Controlled Trial Multicenter Study
Comparison of the analgesic effects of "superficial" and "deep" repetitive transcranial magnetic stimulation in patients with central neuropathic pain: a randomized sham-controlled multicenter international crossover study.
We directly compared the analgesic effects of "superficial" and 'deep" repetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex in patients with central neuropathic pain. Fifty-nine consecutive patients were randomly assigned to active or sham "superficial" (using a figure-of-8 [F8]-coil) or "deep" (using a Hesed [H]-coil) stimulation according to a double-blind crossover design. Each treatment period consisted of 5 daily stimulation sessions and 2 follow-up visits at 1 and 3 weeks after the last stimulation session. ⋯ The analgesic effects of both types of coils had a similar magnitude but were only moderately correlated ( r = 0.39, P = 0.02). The effects of F8-coil stimulation appeared earlier, whereas the effects of H-coil stimulation were delayed, but tended to last longer (up to 3 weeks) as regards to several secondary outcomes (PGIC and total NPSI score). In conclusion, "deep" and "superficial" rTMS induced analgesic effects of similar magnitude in patients with central pain, which may involve different mechanisms of action.