Background: Management of neuropathic pain (Neu P) is complex and difficult. Although thereare several therapeutic options, treatment with Neu P is often inadequate, which led to undertreated patients.Thus, it would be desirable, for Neu P treatment, further multimechanistics approaches. Objective:The aim of the present study was to evaluate, in Neu P management, the effectiveness of “FISIONERV,a gel for topical use. Setting: This study was conducted in the “Rehabilitation Unit of N. Melli’s Hospital,Brindisi, Italy”. Patients and intervention: In this study a double- blind randomized controlled clinical trialwas conducted over 8-week treatment on 58 outpatients affected by Neu P caused by lumbar sciatica orlumbar disk herniation and/or lumbar canal stenosis (31 subjects), or with carpal tunnel syndrome (27subjects), randomly assigned to the following two groups: Group A; n=29, received (fisionerv® gel, 3 times/day) added to physiotherapy (forty minutes-daily session). Group B; n=29 received a vehicle gel (placebo,3 times/day) added to physiotherapy (forty minutes-daily session). Measurements: Pain was assessed by avisual analogue scale (VAS). Neuropathic symptoms frequency (pain, burning, paraesthesiae and numbness)were scored at baseline and at the end of the treatment. Treatment compliance and safety were alsoevaluated. Results: Both groups experienced a significant reduction in VAS and neuropathic symptoms after8-treatment weeks. However, a significant (p<0.05) improvement was observed in group A (VAS mean 5.3(1.10) with respect to group B (VAS mean=6.17 (0.80), already after 4 weeks of treatment. A further VASreduction was recorded at 8 treatment weeks, with significant difference between the treatments (group A:VAS mean=1.89 (0.77); group B: VAS mean=3.79 (1.20) (p<0.001). In addition, more patients of the groupA, than in group B, reported an improvement of their neurophatc pain (p<0.01). No adverse drug reactionwas observed. Conclusion: Use of fisionerv®, in combination with physiotherapy, resulted a useful approachto NP treatment. Clinical rehabilitation impact: These preliminary observations suggest that some interestinggoals (better pain control and physical wellbeing) could be achieved by a multimodal therapy in NP patients.

Topical Fisionerv® is effective in treatment of peripheral neuropathic pain

Andrea Ballini;
2019-01-01

Abstract

Background: Management of neuropathic pain (Neu P) is complex and difficult. Although thereare several therapeutic options, treatment with Neu P is often inadequate, which led to undertreated patients.Thus, it would be desirable, for Neu P treatment, further multimechanistics approaches. Objective:The aim of the present study was to evaluate, in Neu P management, the effectiveness of “FISIONERV,a gel for topical use. Setting: This study was conducted in the “Rehabilitation Unit of N. Melli’s Hospital,Brindisi, Italy”. Patients and intervention: In this study a double- blind randomized controlled clinical trialwas conducted over 8-week treatment on 58 outpatients affected by Neu P caused by lumbar sciatica orlumbar disk herniation and/or lumbar canal stenosis (31 subjects), or with carpal tunnel syndrome (27subjects), randomly assigned to the following two groups: Group A; n=29, received (fisionerv® gel, 3 times/day) added to physiotherapy (forty minutes-daily session). Group B; n=29 received a vehicle gel (placebo,3 times/day) added to physiotherapy (forty minutes-daily session). Measurements: Pain was assessed by avisual analogue scale (VAS). Neuropathic symptoms frequency (pain, burning, paraesthesiae and numbness)were scored at baseline and at the end of the treatment. Treatment compliance and safety were alsoevaluated. Results: Both groups experienced a significant reduction in VAS and neuropathic symptoms after8-treatment weeks. However, a significant (p<0.05) improvement was observed in group A (VAS mean 5.3(1.10) with respect to group B (VAS mean=6.17 (0.80), already after 4 weeks of treatment. A further VASreduction was recorded at 8 treatment weeks, with significant difference between the treatments (group A:VAS mean=1.89 (0.77); group B: VAS mean=3.79 (1.20) (p<0.001). In addition, more patients of the groupA, than in group B, reported an improvement of their neurophatc pain (p<0.01). No adverse drug reactionwas observed. Conclusion: Use of fisionerv®, in combination with physiotherapy, resulted a useful approachto NP treatment. Clinical rehabilitation impact: These preliminary observations suggest that some interestinggoals (better pain control and physical wellbeing) could be achieved by a multimodal therapy in NP patients.
2019
peripheral neuropathies
fisionerv® emulgel
physiatric treatment
neuropatic pain
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/20.500.14085/41278
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