Clinical Observation, Management and Function Of low back pain Relief Therapies (COMFORT): A cluster randomised...

Area of Science:

• Pain Management
• Clinical Trials
• Public Health

Background:

• Opioid analgesics are commonly prescribed for low back pain (LBP) despite limited efficacy and significant harm potential.
• International guidelines recommend caution or avoidance of opioids for LBP, but practical implementation strategies are lacking for clinicians and patients.
• This gap highlights the need for interventions to support adherence to evidence-based opioid prescribing guidelines.

Purpose of the Study:

• To evaluate a multifaceted intervention designed to assist general practitioners (GPs) and their patients in implementing current opioid prescribing guidelines for LBP.
• To assess the intervention's impact on opioid prescribing patterns and patient-reported outcomes.

Main Methods:

• A cluster randomised controlled trial involving at least 40 general practices, randomized 1:1 to an intervention or control group.
• The intervention includes educational outreach to GPs on opioid stewardship and non-pharmacological treatments, alongside patient education on opioid risks and benefits.
• 410 patients prescribed opioids for LBP will be enrolled, with follow-up over 1 year. Primary outcome: cumulative opioid dose (morphine milligram equivalent).

Main Results:

• Primary outcome analysis will compare cumulative opioid doses dispensed over 1 year between intervention and control groups.
• Secondary outcomes include prescription of other medications (benzodiazepines, gabapentinoids, NSAIDs), healthcare utilization, and patient-reported pain and quality of life.
• Intention-to-treat analysis will be employed, with a health economics analysis also planned.

Conclusions:

• The trial aims to provide evidence for an effective intervention to reduce inappropriate opioid prescribing for LBP.
• Successful implementation could lead to safer pain management strategies and improved patient outcomes.
• Findings will inform clinical practice and policy regarding opioid use in chronic pain conditions.