To the Editor:
The subject matter of this letter as it has been mentioned in the title is crucial regarding the Botox neurotoxin (BoNT) injection practice. The question that we pose as rehabilitation doctors is related to the upheaval that was brought by the current pandemia and the lockdown of the private physiotherapeutic (PT) units in the community. I deem that you will agree with the subject. Hence, I hope that you would be kind enough to allow me to provide you with concrete evidence of the reduced effect of BoNT injections against spasticity if PT sessions do not follow. The positive effect of the combined BoNT injections with PT and the need to continue an intensive physiotherapy program before and after the BoNT application for achieving functional improvement is well documented.1 Nevertheless, because of the heterogeneity of the involved studies, the overall impact of adjunct therapies to that of BoNT cannot be approved.2
At the rehabilitation department of the Ioannina University Hospital, the research protocol (NCT04630873) comparing the efficacy of BoNT at different dilutions (i.e., high vs. low) has been designed. The material of this study is patients with spastic hemiparesis treated by BoNT injections. This is followed by gait analysis measurements as the uncontested method for evaluation of the Botulin toxin injection on gait improvement. In a sequential manner, every second patient who meets the inclusion criteria is treated with a low concentration of the drug during the first visit to the outpatient clinic. After a period of 4 months from each visit, another researcher from the clinic is performing blinded the gait analysis. Simultaneously, with the previously mentioned protocol, another research project is being run in our university gait laboratory where we compare the effectiveness of intramuscular injections of BoNT with hemiplegic patients using kinetic and kinematic parameters. Both clinical trials have been started before the lockdown, and we have noticed an improvement in almost all spatiotemporal parameters of gait in injected patients, with some reaching statistical significance.
After the lockdown, almost 50% of our patients, in both clinical trials, failed to show improvements or even worsened in gait parameters. Of our last six patients, three had the worst result. Indicatively, we report the area of the loaded foot and the step length (Table 1). Undoubtedly, the lack of PT after the treatment was of vital importance to this negative outcome. Under the circumstances, we were obliged to pause the research until outpatient sessions of physiotherapy are re-established in the community. In this letter, one of the very many problems that the closure of Physical and Rehabilitation Medicine community services arises during the COVID-19 shutdown is being highlighted. There is a vital need that PT services remain open in the community for targeted population, like the patients treated with BoNT injection. We appeal to the concerned authority and the government to take measures that will allow their continuation at any cost.
TABLE 1 -
||Area B, cm2
||Area A, cm2
||H-N Step Length B, cm
||H-N Step Length A, cm
|Before lockdown mean all patients
|After lockdown pt 1
|After lockdown pt 2
A after Botox; B, before Botox; H, hemiplegic; N, normal.
In the pt 1, while the area improved, the step length worsens, and in the pt 2, both parameters had worse results.
George I. Vasileiadis, MD, PhD, SFEBPRM
Dimitris Varvarousis, MD, PhD
Avraam Ploumis, MD, PhD
Department of Physical and
Ioannina University Hospital
1. Akbaş AN: How does botulinum toxin injection and physiotherapy complement each other in cerebral palsy? Botulinum toxin therapy manual for dystonia and spasticity. In: Rosales RL, Dressler D (eds), IntechOpen
2016. doi: 10.5772/66693
2. Kinnear BZ: Physical therapies as an adjunct to Botulinum toxin-A injection of the upper or lower limb in adults following neurological impairment. Syst Rev