Melatonin treatment has consistent but transient beneficial effects on sleep measures and pain in patients with severe chronic pain: the DREAM-CP randomised controlled trial.

BACKGROUND: Sleep disturbance is a major issue for patients with chronic pain. Melatonin has been shown to improve symptoms of fibromyalgia, but its efficacy in other chronic non-malignant pain conditions is not fully known. Hence, we determined the effect of melatonin in patients with severe noncancer chronic pain. METHODS: This was a randomised double-blinded crossover trial of modified-release melatonin as Circadin™ compared with placebo. Sixty male and female subjects with chronic severe pain were randomised to receive either 2 mg of Circadin™ or placebo before sleep for 6 weeks, followed by a >4 week washout, then crossing over to the other treatment. Sleep disturbance, quality, and latency were measured using three different validated sleep assessment tools. The primary outcome measure was self-reported sleep disturbance after 6 weeks of treatment. Adverse events were also recorded. RESULTS: Sleep disturbance after 6 weeks was not significantly altered by melatonin treatment, but differences between melatonin and placebo treatment periods after 3 weeks were seen: sleep disturbance (P=0.014), latency (P=0.04), overall sleep quality (P=0.004), and effect of pain on sleep (P=0.032). Pain intensity scores improved during both treatment periods (both P<0.001). There were no differences in adverse events between treatment periods. CONCLUSIONS: Circadin™ treatment did not improve sleep disturbance in patients with severe chronic pain compared with placebo at 6 weeks, but there were consistent improvements in aspects of sleep in the shorter term. Given its favourable safety profile, it could be beneficial for some patients with chronic pain. CLINICAL TRIAL REGISTRATION: ISRCTN12861060.

Supraneural versus Infraneural Approach to transforaMinal Epidural StEroid injection for unilateral lumbosacral radicular pain (SIAMESE): a study protocol for a randomised non-inferiority trial.

Background: Lumbosacral radicular pain is commonly treated by transforaminal steroid epidural injection. There are two methods: the supraneural and the infraneural approaches. The supraneural approach can result in rare but catastrophic consequences from injury to the radiculomedullary artery. The infraneural technique avoids the artery; both approaches show efficacy and are used locally. Methods: This is a protocol for a randomised, single-blinded, non-inferiority trial of infraneural vs supraneural transforaminal epidural injection for lumbosacral radicular pain at a tertiary referral pain management clinic. Adult patients (n=92) with moderate-to-severe lumbosacral radicular pain of >3 months duration, scheduled for transforaminal epidural steroid injection, will be randomised to epidural by either the infraneural or supraneural approach. Only the treating physicians will know which route is used. The primary outcome measure is the differential impact on pain intensity score at 3 months. Secondary outcome measures will include disability and function scores, sleep and activity measures, and adverse events. Participants will be followed up for 12 months. Conclusions: This study will determine whether the techniques are comparable and, if so, will enable recommendations for the use of an approach without risk of artery damage and catastrophic injury. Clinical trial registration: ISRCTN 36195887.