Metformin for low back pain: Study protocol for a randomised, double-blind, placebo-controlled trial

Area of Science:

• Pharmacology
• Pain Management
• Clinical Trials

Background:

• Chronic low back pain (CLBP) is a significant cause of disability with limited effective treatments.
• Metformin, a widely used diabetes drug, exhibits pleiotropic effects, including potential modulation of pain pathways.
• Investigating metformin's efficacy for CLBP addresses a critical unmet medical need.

Purpose of the Study:

• To determine if metformin reduces pain intensity in individuals with chronic low back pain over a 4-month period.
• To evaluate the effects of metformin on low back disability, physical activity levels, and narcotic use.
• To assess the safety and tolerability of metformin in this patient population.

Main Methods:

• A randomized, double-blind, placebo-controlled trial involving 123 participants with CLBP.
• Participants received either metformin (2g daily) or a placebo for 4 months.
• Primary outcome: change in pain intensity via a 100mm visual analogue scale; secondary outcomes: disability, physical activity, and narcotic use.

Main Results:

• Primary analysis will be conducted on an intention-to-treat basis.
• Changes in pain intensity, low back disability, physical activity, and narcotic use will be compared between groups.
• Adverse events will be systematically recorded and reported.

Conclusions:

• If metformin proves effective, it could provide a novel, accessible therapeutic option for chronic low back pain.
• This study's findings will contribute valuable evidence regarding metformin's role in non-diabetic pain management.
• Successful outcomes could impact clinical practice and reduce the societal burden of low back pain.