Peri-Neuromal Botulinum Toxin Injection for War-Related Postamputation Pain: A Pragmatic, Multicenter, Comparative-Effectiveness Study.

Objectives: To determine the comparative-effectiveness of botulinum toxin (BT) injections vs. comprehensive medical and surgical treatment (CMST) for war-related postamputation pain.

Design: Prospective, comparative-effectiveness study evaluating outcomes in patients treated with BT or CMST in 2 Ukrainian hospitals.

Participants: Patients with at least 2 out of 10 residual (RLP) or phantom (PLP) limb pain were included.

Interventions: In the BT group, patients received BT injections around neuromas in the residual limb (peri-neuromal), subcutaneously over sensitized tissue, or as trigger point injections, plus physical and pharmacotherapy as indicated. The CMST group received injections, surgical therapies, physical and pharmacotherapies, and integrative treatments.

Main outcome measures: Mean reduction in RLP and PLP at 3-month follow-up. Secondary outcome measures were RLP and PLP and success defined as ≥30% decrease in PAP.

Results: At 3 months, the reduction in PLP scores was greater in the CMST than the BT group (2.0±2.0 vs. 3.5±3.5, p=0.002). For RLP, the reduction did not differ significantly between groups (BT 2.0±2.5 vs. CMST 3.0±2.8, p=0.50). Conversely, the reduction in PLP at 1-month favored BT (4.0±3.5 vs. 1.0±2.5, p>0.001), with no significant difference in RLP reduction. Responder rates favored BT for PLP at 1-month (68.6% vs. 43.1%, P=0.01), and CMST for RLP (97.1% vs. 63.2%, p<0.001) but not PLP at 3-months.

Conclusions: On some measures, BT outperforms or is non-inferior to CMST at 1-month but not 3-months, suggesting multimodal treatment is superior in the long-term.