A Prospective Randomized Double-blinded Pilot Study to Examine the Effect of Botulinum Toxin Type A Injection Versus Lidocaine/Depomedrol Injection on Residual and Phantom Limb Pain

Abstract

Objective Botulinum toxin type A (Botox) injection has been used to manage pain. However, it remains to be proved whether Botox injection is effective to relieve residual limb pain (RLP) and phantom limb pain (PLP). Design Randomized, double-blinded pilot study. Setting Medical College and an outpatient clinic in Department of Physical Medicine and Rehabilitation. Participants Amputees (n=14) with intractable RLP and/or PLP who failed in the conventional treatments. Interventions Study amputees were randomized to receive 1 Botox injection versus the combination of Lidocaine and Depomedrol injection. Each patient was evaluated at baseline and every month after the injection for 6 months. Main Outcome Measure The changes of RLP and PLP as recorded by VAS, and the changes of the pressure pain tolerance as determined by a pressure algometer. Results All patients completed the protocol treatment without acute side effects, and monthly assessments of RLP, PLP, and pain tolerance after the treatment. The time trend in the outcomes was modeled as an immediate change owing to the treatment followed by a linear tread afterward. Repeated measures were incorporated using mixed effects modeling. We found that both Botox and Lidocaine/Depomedrol injections resulted in immediate improvements of RLP (Botox: P=0.002; Lidocaine/Depomedrol: P=0.06) and pain tolerance (Botox: P=0.01; Lidocaine/Depomedrol: P=0.07). The treatment effect lasted for 6 months in both groups. The patients who received Botox injection had higher starting pain than those who received Lidocaine/Depomedrol injection (P=0.07). However, there were no statistical differences in RLP and pain tolerance between these 2 groups. In addition, no improvement of PLP was observed after Botox or Lidocaine/Depomedrol injection. Conclusions Both Botox and Lidocaine/Depomedrol injections resulted in immediate improvement of RLP (not PLP) and pain tolerance, which lasted for 6 months in amputees who failed in conventional treatments.

Botulinum toxin A, brain and pain

“…In the past decade, several hundreds of reports of pain relief due to BoNT/A off-label use in various clinical conditions have been published. Beneficial effects in pain have been reported in interstitial cystitis (Kuo, 2013, Russell et al, 2013, chronic arthritis (Chou et al, 2010), residual limb pain (Wu et al, 2012), different types of neuropathic pain (Ranoux et al, 2008;Zuniga et al, 2008) including diabetic neuropathy (Relja and Miletić, 2005;Yuan et al, 2009;Chen et al, 2013), masticatory pain etc. Although some double-blind, placebo controlled studies have been performed (review by Jabbari and Machado, 2011), clinical reports on BoNT/A effectiveness are dominated by studies based on a small number of patients or individual case reports.…”

“…Although some double-blind, placebo controlled studies have been performed (review by Jabbari and Machado, 2011), clinical reports on BoNT/A effectiveness are dominated by studies based on a small number of patients or individual case reports. In the literature there is an increasing number of rare conditions with reported BoNT/A effectiveness on pain such as Parry Romberg syndrome (Borodic et al, 2013), Morton neuroma (Climent et al, 2013), painful legs and moving toes syndrome (Rodriguez and Fernandez, 2013), post-thoracotomy pain (Fabregat et al, 2013) post-amputation limb pain (Wu et al, 2012), etc.…”

“…For example, migraine is by definition a CNS disease and it remains unclear why peripherally acting BoNT/A can have a long lasting beneficial effect on it. Few reports on the beneficial effect of BoNT/A on phantom pain (Jin et al, 2009;Wu et al 2012) additionally indicate the limitations of the peripheral hypothesis.…”

Botulinum Toxin for Neuropathic Pain and Spasticity: An Overview

“…Additionally onabotulinumtoxinA improved general activity, mood and anxiety scores [33]. [42] Jin et al …”

Botulinum Toxin for Pain Syndromes

“…При анализе исследований, в которых применялись инъ-екции БТА для лечения этих нозологий, была показана эффективность терапии: выраженное уменьшение боле-вого синдрома, а в случае с ампутированной конечно-стью появлялась возможность использовать протезы, что ранее было невозможно из-за выраженной боли [67][68][69][70].…”