Metformin for low back pain: A clinical trial to examine the effectiveness of metformin for chronic low back pain.

Phase 3

Recruiting

• Conditions: low back pain; Musculoskeletal - Other muscular and skeletal disorders; Anaesthesiology - Pain management

• Registration Number: ACTRN12621001453875
• Lead Sponsor: Prof Flavia Cicuttini

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-25
• Last Update Posted: 23 January 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 124

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified