Mesotherapy versus Systemic Therapy in the Treatment of Acute Low Back Pain: A Randomized Trial

Abstract

Pharmacological therapy of back pain with analgesics and anti-inflammatory drugs is frequently associated with adverse effects, particularly in the elderly. Aim of this study was to compare mesotherapic versus conventional systemic administration of nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids in patients with acute low back pain. Eighty-four patients were randomized to receive anti-inflammatory therapy according to the following protocols: (a) mesotherapy group received the 1st and 4th day 2% lidocaine (1 mL) + ketoprofen 160 mg (1 mL) + methylprednisolone 40 mg (1 mL), then on 7th, 10th, and 13th day, 2% lidocaine (1 mL) + ketoprofen 160 mg (1 mL) + methylprednisolone 20 mg (1 mL) (b) conventional therapy group received ketoprofen 80 mg × 2/die and esomeprazole 20 mg/die orally for 12 days, methylprednisolone 40 mg/die intramuscularly for 4 days, followed by methylprednisolone 20 mg/die for 3 days, and thereafter, methylprednisolone 20 mg/die at alternate days. Pain intensity and functional disability were assessed at baseline (T0), at the end of treatment (T1), and 6 months thereafter (T2) by using visual analogic scale (VAS) and Roland-Morris disability questionnaire (RMDQ). In both groups, VAS and RMDQ values were significantly reduced at the end of drug treatment and after 6 months, in comparison with baseline. No significant differences were found between the two groups. This suggests that mesotherapy may be a valid alternative to conventional therapy in the treatment of acute low back pain with corticosteroids and NSAIDs.

Figure 1

Study design and drug treatment.

Figure 2

Injection points of a single mesotherapic treatment. Drug injections were administered along the running of sciatic nerve, through specific needles (30 G × 4 mm) (see Methods, for details).

Figure 3

Effect of anti-inflammatory drugs on the reduction of pain, as measured by visual analogic scale (VAS) in patients with acute low back pain. Drug treatment was done either via mesotherapy or via standard systemic route of administration (see methods for details). T0 = baseline, T1 = end of the 12-day treatment and T2 = six months after the end of drug treatment. Values are mean ± SD from 42 patients.

Figure 4

Effect of anti-inflammatory drugs on the reduction of functional disability, as measured by Roland-Morris disability questionnaire (RMDQ), in patients with acute low back pain. Drug treatment was done either via mesotherapy or via standard systemic route of administration. T0 = baseline, T1 = end of 12-day treatment, and T2 = six months after the end of drug treatment. Values are mean ± SD from 42 patients.

Figure 5

Therapeutic outcome of mesotherapy in comparison with conventional systemic therapy for acute low back pain. These two routes of administration resulted in comparable efficacy, despite the lower (approximately 50%) total amount of drug administered via mesotherapy.