Metformin for low back pain: A double blind, randomised controlled trial to examine the effectiveness of metformin for chronic low back pain in adults.

Prof Flavia Cicuttini0 个研究点目标入组 124 人开始时间: 2021年10月25日最近更新: 2023年1月23日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

Prof Flavia Cicuttini