A multicenter randomized controlled trial on the efficacy of intradiscal methylene blue injection for chronic discogenic low back pain: the IMBI study

Abstract

A study published in PAIN in 2010 showed remarkable effects of intradiscal methylene blue (MB) injections compared with placebo on pain intensity in patients with chronic discogenic low back pain (CD-LBP). Both groups received lidocaine hydrochloride injections for pain associated with the procedure. We replicated the design of the previously published study and performed a multicenter, double-blind, randomized, placebo-controlled trial to assess whether the extraordinary effects of MB on pain intensity could be confirmed. The primary outcomes were treatment success defined as at least 30% reduction in pain intensity and the Patients' Global Impression of Change 6 months after the intervention. We included 84 patients with CD-LBP of which 14 (35%) in the MB plus lidocaine group showed treatment success compared with 11 (26.8%) in the control group who received placebo plus lidocaine (P = 0.426). Twenty-seven percent of all participants treated with MB stated that their overall health improved much or very much (Patients' Global Impression of Change), vs 25.6% in the placebo group (P = 0.958). We were unable to confirm that intradiscal MB injections are better capable of significantly reducing pain in patients with CD-LBP 6 months after treatment compared with placebo. We observed that over one-quarter of patients receiving only lidocaine injections reported treatment success, which is in contrast with the previously published study. Our results do not support the recommendation of using intradiscal MB injections for patients with CD-LBP.

The Lancet Series call to action to reduce low value care for low back pain: an update

“…Recently published replication trials have also failed to confirm the promising results of the initial trials of novel therapies such as antibiotics as treatment of low back pain in people with Modic changes 9 and intradiscal methyl blue injections as treatment of persistent low back pain of presumed intradiscal origin. 54 Similarly, the Matching Appropriate Treatments to Consumer Healthcare needs trial, 18 which tested risk-stratification based upon physical and psychosocial obstacles to recovery combined with physical therapist training, also failed to replicate the positive findings observed in the initial UK STarT Back trial. 46 This reconfirms the importance of replication trials conducted in the same and different health care settings.…”

Could methylene blue be used to manage burning mouth syndrome? A pilot case series

“…MB is used either as a topical or an injectable agent, intradermally or intravenously. Since the first reports of its positive effects in the treatment of neuritic and rheumatic diseases, it has been used in dermatology for the treatment of itch [41][42][43][44][45] and especially for intractable itch which can be viewed as a neuropathic condition [50]; in anal surgery [37,52] a recent meta-analysis concluded to significant improvement of pain after anorectal surgery [36] or in orthopedics where injection of MB in the radicular disc was used for treating chronic low back pain [35] but with controversial effects [34].…”

“…MB is a cationic heterocyclic aromatic chemical compound (Methylthioninium Chloride) that has been used for more than 130 years in Medicine as a vital dye with very low tissue toxicity [32]. Among its many medical effects such as detoxification, disinfection and positive psychotropic effects [33], it has shown analgesics effects in rheumatology, orthopedics [34,35] and dermatology [35][36][37][38][39][40][41][42][43][44][45] and in experimental pain [46]. Interestingly MB has even shown analgesic effects in both orofacial pain conditions [47,48] and neuropathic pain [40,49] which prompted us to consider it as a possibly viable treatment option for BMS.…”

The clinical efficacy and experience of bipedicular percutaneous vertebroplasty combined with postural reduction in the treatment of Kümmell’s disease

“…So the literature then used Kümmell's disease to name the disease. Kümmell's disease is a special type of osteoporotic vertebral cavity-like fracture that mainly occurs in the thoracolumbar region [3], which is a delayed vertebral collapse caused by osteonecrosis and non-union [4].…”