STUDY DESIGN

Prospective clinical study of intradiscal methylene blue injection for the treatment of lumbar discogenic pain.

OBJECTIVE

The objective of this study was to collect information about efficacy, safety, and acceptability of the intervention, gain and burden of outcome measures, and sample size assumptions for a potential following randomized controlled trial (RCT). If the pilot study demonstrates that this treatment is potentially effective and safe, and the methods and procedures used in this study are feasible, a RCT follows.

SUMMARY OF BACKGROUND DATA

Low back pain (LBP) is a highly common problem with a lifetime prevalence of more than 70%. A substantial part of chronic LBP is attributable to degenerative changes in the intervertebral disc. A recently published RCT assessing the treatment intradiscal injection of methylene blue for chronic discogenic LBP, showed exceptionally good results.

METHODS

Patients were selected on clinical criteria, magnetic resonance imaging, and a positive provocative discogram. The primary outcome measure was mean pain reduction at 6 months.

RESULTS

Fifteen consecutive patients with chronic lumbar discogenic pain enrolled in a multicenter prospective case series in two interventional pain treatment centers in the Netherlands. Six months after the intervention, 40% of the patients claimed at least 30% pain relief. In patients who responded, physical function improved and medication use diminished. We observed no procedural complications or adverse events. Predictors for success were Pfirrmann grading of 2 or less and higher quality of life mental component scores.

CONCLUSIONS

Our findings of 40% positive respondents, and no complications, give reason to set up a randomized, double-blind, placebo-controlled, trial.