Pain
-
Randomized Controlled Trial
Monthly vitamin D supplementation, pain, and pattern of analgesic prescription: secondary analysis from the randomized, double-blind, placebo-controlled Vitamin D Assessment study.
Observational studies suggest that vitamin D deficiency is associated with higher risk of pain. However, evidence on the effect of vitamin D supplementation on pain is limited and contradictory. The aim of this study was to compare the effect of monthly high-dose vitamin D supplementation on a pain impact questionnaire (PIQ-6) score and prescription of analgesics in the general population. ⋯ Similar results were observed for dispensing of nonsteroidal anti-inflammatory drugs (RR = 0.94; P = 0.24) and other nonopioids (RR = 0.98; P = 0.34). Focusing on vitamin D deficient participants (<50 nmol/L, 24.9%), there was a lower risk of dispensing nonsteroidal anti-inflammatory drugs in the vitamin D group compared with placebo (RR = 0.87; P = 0.009); all other subgroup analyses were not significant. Long-term monthly high-dose vitamin D supplementation did not improve mean PIQ-6 score or reduce analgesic dispensing in the general population.
-
Randomized Controlled Trial Multicenter Study
Systemic effects of epidural steroid injections for spinal stenosis.
This analysis of the lumbar epidural steroid injections for spinal stenosis multicenter randomized controlled trial data identifies the degree of and risk factors for cortisol suppression after epidural steroid injections in older adults with spinal stenosis. Four hundred patients aged 50 years and older with back or leg pain and central lumbar spinal stenosis completed baseline demographic and psychosocial measures. Morning serum cortisol levels were measured at baseline and 3 weeks after initial injection. ⋯ The effect on 3-week cortisol changes did not differ by demographic or patient-level characteristics. Those treated with methylprednisolone or triamcinolone had an average 3-week cortisol reduction of 41.0% (P = 0.005) and 41.6% (P < 0.001) from baseline, respectively, whereas patients treated with betamethasone or dexamethasone were not significantly different than comparable patients in the lidocaine arm. The higher rates of cortisol suppression at 3 weeks in those receiving epidural corticosteroid injections, particularly with longer-acting insoluble corticosteroid formulations, are consistent with sustained systemic absorption of corticosteroid.
-
Randomized Controlled Trial
Long-term use of naldemedine in the treatment of opioid-induced constipation in patients with chronic noncancer pain: a randomized, double-blind, placebo-controlled phase 3 study.
The long-term safety of naldemedine, a peripherally acting µ-opioid receptor antagonist, was evaluated in patients with opioid-induced constipation and chronic noncancer pain in a 52-week, randomized, double-blind, phase 3 study. Eligible adults who could be on a routine laxative regimen were randomized 1:1 to receive once-daily oral naldemedine 0.2 mg (n = 623) or placebo (n = 623). The primary endpoint was summary measures of treatment-emergent adverse events (AEs). ⋯ Sustained significant improvements in bowel movement frequency and overall constipation-related symptoms and quality of life were observed with naldemedine (P ≤ 0.0001 vs placebo at all time points). Naldemedine was generally well tolerated for 52 weeks and did not interfere with opioid-mediated analgesia or precipitate opioid withdrawal. Naldemedine significantly increased bowel movement frequency, improved symptomatic burden of opioid-induced constipation, and increased patients' quality of life vs placebo.
-
Randomized Controlled Trial
Psychological flexibility mediates the effect of an online-based acceptance and commitment therapy for chronic pain: an investigation of change processes.
One way to improve treatment effects of chronic pain is to identify and improve control over mechanisms of therapeutic change. One treatment approach that includes a specific proposed mechanism is acceptance and commitment therapy (ACT) with its focus on increasing psychological flexibility (PF). The aim of the present study was to examine the role of PF as a mechanism of change in ACT. ⋯ Structural equation modelling analyses revealed that changes in PF significantly mediated pretreatment to follow-up changes in all outcomes in the intervention groups compared with waitlist (standardized estimates ranged from I0.16I to I0.69I). Global model fit yielded modest but acceptable results. Findings are consistent with the theoretical framework behind ACT and contribute to growing evidence, supporting a focus on PF to optimize treatment effects.
-
Randomized Controlled Trial
Computerised training improves cognitive performance in chronic pain: a participant-blinded randomised active-controlled trial with remote supervision.
Chronic pain is associated with reduced efficiency of cognitive performance, and few studies have investigated methods of remediation. We trialled a computerised cognitive training protocol to determine whether it could attenuate cognitive difficulties in a chronic pain sample. Thirty-nine adults with chronic pain (mean age = 43.3, 61.5% females) were randomised to an 8-week online course (3 sessions/week from home) of game-like cognitive training exercises, or an active control involving watching documentary videos. ⋯ This study provides preliminary evidence that supervised cognitive training may be a viable method for enhancing cognitive skills in persons with chronic pain, but transfer to functional and clinical outcomes remains to be demonstrated. Active control results suggest that activities perceived as relaxing or enjoyable contribute to improved perception of well-being. Weekly contact was pivotal to successful program completion.