None listed
Conditions
Brief summary
Low back is the leading cause of disability globally. Despite this, effective treatments are limited and narcotic use is alarmingly high. Metformin is a widely prescribed, safe and low-cost medication been used clinically for over 50 years as first-line therapy for type 2 diabetes. Recent evidence has shown that metformin can inhibit the mTOR pathway which is a major contributor to pain hypersensitivity, while human clinical studies show preliminary evidence that metformin may reduce pain in individuals with chronic low back pain. A randomised clinical trial is urgently needed to determine if metformin is effective in the management of individuals with chronic low back pain. AIMS: To examine the efficacy of metformin compared to placebo on pain intensity over 4 months in individuals with chronic LBP. HYPOTHESIS: We hypothesize that metformin will be more effective in reducing pain in individuals with chronic low back pain compared with a placebo. PARTICIPANTS: 124 participants with chronic low back pain. INTERVENTION: Metformin (2000 mg) once daily COMPARATOR: Identical placebo once daily OUTCOME: Change in back pain intensity at 4 months SIGNIFICANCE: Given the large and growing burden of low back pain and it associated costs, this trial has the potential to deliver enormous health, economic, and social benefits. The repositioning of metformin, a cheap, safe, old drug for this new indication, offers an unprecedented opportunity to significantly and immediately impact the management of low back pain globally.
Interventions
The intervention is metformin (up to 2000mg) taken once daily with the evening meal as an oral tablet. It will be initiated at a dose of 500 mg once daily for 2 weeks and then increased by 500 mg every 2 weeks. Over 6 weeks, the dose of study medication will be titrated to 2000 mg once daily. Treatment will be provided for 4 months, including the 6 week titration period. Adherence to study medication will be assessed by bottle returns and pill count.
Sponsors
Prof Flavia Cicuttini
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
We will recruit individuals aged 18-65 years with chronic low back pain. Chronic low back pain will be defined as pain localised below the lower border of the rib cage and above the gluteal folds that has been present for more than 3 months. A minimum pain score of 30 or more on a 100mm visual analogue scale in the previous week will be required for inclusion.
Exclusion criteria
Participants with any of the following will be excluded: (i) specific pathological entities, such as cauda equina syndrome, infection, metastasis, (ii) major co-existing illness or co-morbidity (iii) other significant musculoskeletal or chronic pain conditions (e.g. fibromyalgia), (iv) patients with any history of psychosis, (v) patients with any diagnosed mental health condition, (v) acute or chronic renal or liver impairment, (vi) known or newly diagnosed diabetes requiring anti-hyperglycemic therapy or previous adverse reaction to metformin; (vii) use of any investigational drugs or device within 30 days prior to randomisation; (viii) surgery in the previous 12 months or planned surgery or invasive procedures over the course of the trial (ix) inability to provide informed consent, (x) pregnancy, planning to become pregnant within 12 months or breastfeeding. We will also exclude individuals who are using narcotics and have an oral morphine equivalence of 100mg or more daily. Use of menopausal hormone therapy or oral contraceptive pill will be permitted as long as the dose has been stable for at least 30 days prior to study entry.
Outcome results
None listed