OPAL: The first placebo-controlled trial of opioid analgesia for acute spinal pai

Phase 4

Completed

• Conditions: Acute spinal pain: low back pain and/or neck pain; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12615000775516
• Lead Sponsor: The George Institute for Global Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-27
• Study Completion: 2022-02-24
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 347

Inclusion Criteria

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 Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified