OPAL: The first placebo-controlled trial of opioid analgesia for acute spinal pain
In patients with acute spinal pain, will taking a short course of an opioid analgesic, compared to placebo, in addition to receiving guideline care be more beneficial in reducing pain severity?
The George Institute for Global Health
346 participants
Feb 29, 2016
Interventional
Conditions
Summary
Low back pain and neck pain are extremely prevalent and are responsible for an enormous burden of disease both in Australia and globally. Strong analgesics, such as opioid analgesics, are recommended by clinical practice guidelines for people with acute low back pain or neck pain who are slow to recover and require more pain relief. The latest Australian data suggest that opioid analgesics are now the most widely prescribed medicine for low back pain and neck pain in general practice. Despite the widespread use, there are no randomised, placebo-controlled trials evaluating opioid analgesics for acute low back pain or neck pain. Concerns regarding opioid use are further heightened due to the risks of adverse events, some of which can be serious such as opioid misuse, poisoning, and deaths. Given the lack of evidence on efficacy and concerns regarding safety, there is an urgent need to understand whether opioid analgesics are beneficial for patients with acute low back pain and/or neck pain. OPAL is a randomised, placebo-controlled, triple-blinded trial that will investigate the judicious use of an opioid analgesic in 346 participants with acute low back pain and/or neck pain who are slow to recover. Participants will be recruited from general practice and randomised to receive the opioid analgesic (modified-release oxycodone up to 20 mg per day) or placebo in addition to guideline care for up to 6 weeks. The primary outcome will be pain severity measured up to 12 months with treatment efficacy over the 6-week treatment period being the primary time point for analysis. Medication-related adverse events will be assessed and a cost-effectiveness analysis will be conducted. We will additionally assess long-term use and risk of misuse of opioid analgesics for up to 12 months. The results of this study will be critical in providing robust evidence to inform the quality use of opioid analgesia in acute low back pain and neck pain. The results will also influence international clinical practice guidelines and most importantly, improve care for patients suffering acute spinal pain.
Eligibility
Inclusion Criteria1
- Low back pain and/or neck pain no more than 12 weeks since onset, of at least moderate pain severity, and is considered by the treating doctor as appropriate for opioid analgesia.
Exclusion Criteria1
- Serious spinal pathology, contraindications to opioid analgesics, have taken an opioid analgesic for the current episode at a dose > 15mg of oral morphine equivalent per day for 5 or more consecutive days, spinal surgery in the preceding 6 months, scheduled or being considered for spinal surgery or interventional procedure, < 18 years of age, not having sufficient English or suitable translation is not available, or, for female participants only, planning conception, or is pregnant or breast-feeding.
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Interventions
Modified-release oxycodone tablets for up to 6 weeks, administered orally. Participants will start at a dose of 5 mg, 2 times a day which will gradually be titrated up to the maximum dose of 10 mg, 2 times a day based on individual participant progress, tolerability and sedation score monitored by a study general practitioner at up to weekly intervals, up to 6 weeks in total. Treatment will continue until ‘adequate improvement’ (0 to 1 out of 10 pain for 3 consecutive days) or for a maximum of 6 weeks. When adequate improvement is achieved or after a maximum of 5 weeks of treatment, the study medication will be titrated down to cessation over 1 week. Adherence to study medication will be monitored by a daily medication diary and returned medication count. In addition all participants will receive guideline care, including advice (patient reassurance, staying active and avoiding bed rest) and, if required, other guideline-recommended treatments. For example, spinal manipulative therapy may be offered if pain is over 12 weeks in duration since onset and if more pain relief is required, simple analgesics or adjuvants may be provided in addition to the study medication in accordance to the WHO analgesic ladder. However, no concomitant opioid analgesics should be used.
Locations(2)
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ACTRN12615000775516