The effects of botulinum toxin type A injection on pain symptoms, quality of life, and sleep quality of patients with diabetic neuropathy: A randomized double-blind clinical trial

Author(s):  
Hossein Salehi ◽  
Moein Moussaei ◽  
Zahra Kamiab ◽  
Alireza Vakilian

Background: Neuropathic pain is one of the most common problems in patients with diabetes mellitus (DM). In this study, the effect of botulinum toxin type A (BTX-A) on neuropathic pain, quality of sleep, and quality of life of diabetic patients with sensorimotor polyneuropathy was studied. Methods: This randomized placebo-controlled trial study was carried out in a double-blind (patientresearcher) method. The study was performed on 32 patients with type 2 DM. Neuropathy was confirmed by Douleur Neuropathique 4 (DN4) Questionnaire and nerve conduction study (NCS). The patients were randomly assigned to two intervention and control groups based on the random numbers table. After selecting the subjects, we used 36-Item Short Form Health Survey (SF-36), Neuropathic Pain Scale (NPS),  Visual Analogue Scale (VAS), and Pittsburgh Sleep Quality Index (PSQI) questionnaires before and after 3 months of 100 units BTX-A injection (as intervention group) or same amount of chloride sodium (as control group) to the subjects' feet. The data were analyzed by SPSS software using independent twosample t-test, chi-square test, and one-way repeated measures analysis of variance (ANOVA). Results: 12 male and 20 female patients participated in this study. There was a significant difference in the mean VAS, PSQI, physical dimension of the SF-36, and some NPS indices over time (12 weeks) (P < 0.001). Conclusion: The results of this study showed that BTX-A reduced neuropathic pain and improved the quality of life and sleep in people with diabetic neuropathy.  

2019 ◽  
Vol 77 (5) ◽  
pp. 346-351 ◽  
Author(s):  
Emanuel de Jesus Soares de Sousa ◽  
Gustavo Celeira de Sousa ◽  
Vitor Ferreira Baia ◽  
Danusa Neves Somensi ◽  
Marília Brasil Xavier

ABSTRACT Neuropathic pain is a chronic syndrome that is difficult to treat and often affects patients with leprosy. Recommended treatment includes the the use of analgesic drugs, codeine, tricyclic antidepressants, neuroleptics, anticonvulsants and thalidomide, but without consensus on uniform dose and fully satisfactory results. Objective: To analyze botulinum toxin type A (BoNT-A) effectiveness in treatment of chronic neuropathic pain in refractory leprous patients, as well as evaluate and compare the quality of life of patients before and after using the medication. Methods: We used a specific protocol including clinical, demographic, DN4 protocol, analogue scale (VAS), sensory evaluation and evaluation of the WHOQOL-BREF. Therapeutic intervention was performed with BOTOX® BTX-A 100U administered subcutaneously. Fifteen patients were evaluated on days 0, 10 and 60. Results: Patients on VAS showed pain between 5 and 10, in one case there was complete pain relief in 60 days, while others showed improvement in the first week with the return of symptoms with less intensity after this period. WHOQOL-BREF's domains Quality of Life and Physical to have a significant increase in QOL. Conclusion: BoNT-A proved to be a good therapeutic option in relieving pain with improved quality of life for these patients.


BMJ Open ◽  
2014 ◽  
Vol 4 (10) ◽  
pp. e005150 ◽  
Author(s):  
Margaret Mordin ◽  
Catherine Masaquel ◽  
Chandra Abbott ◽  
Catherine Copley-Merriman

ObjectiveTo describe the health-related quality of life (HRQOL) burden of cervical dystonia (CD) and report on the HRQOL and patient perception of treatment benefits of abobotulinumtoxinA (Dysport).DesignThe safety and efficacy of a single injection of abobotulinumtoxinA for CD treatment were evaluated in a previously reported international, multicenter, double-blind, randomised trial. HRQOL measures were assessed in the trial and have not been previously reported.SettingMovement disorder clinics in the USA and Russia.ParticipantsPatients had to have a diagnosis of CD with symptoms for at least 18 months, as well as a total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score of at least 30; a Severity domain score of at least 15; and a Disability domain score of at least 3. Key exclusion criteria included treatment with botulinum toxin type A (BoNT-A) or botulinum toxin type B (BoNT-B) within 16 weeks of enrolment.InterventionsPatients were randomised to receive either 500 U abobotulinumtoxinA (n=55) or placebo (n=61).Primary and secondary outcome measuresEfficacy assessments included TWSTRS total (primary end point) and subscale scores at weeks 0, 4, 8, 12; a pain visual analogue scale at weeks 0 and 4; and HRQOL assessed by the SF-36 Health Survey (SF-36; secondary end point) at weeks 0 and 8.ResultsPatients with CD reported significantly greater impairment for all SF-36 domains relative to US norms. Patients treated with abobotulinumtoxinA reported significantly greater improvements in Physical Functioning, Role Physical, Bodily Pain, General Health and Role Emotional domains than placebo patients (p≤0.03 for all). The TWSTRS was significantly correlated with Physical Functioning, Role Physical and Bodily Pain scores, for those on active treatment.ConclusionsCD has a marked impact on HRQOL. Treatment with a single abobotulinumtoxinA injection results in significant improvement in patients’ HRQOL.Trial registration numberThe trial is registered at ClinicalTrials.gov, numbers NCT00257660 and NCT00288509.


2013 ◽  
Vol 19 (1) ◽  
pp. 12-18 ◽  
Author(s):  
Azize Esra Gürsoy ◽  
Işıl Ugurad ◽  
Gülsen Babacan-Yıldız ◽  
Mehmet Kolukısa ◽  
Arif Çelebi

2021 ◽  
Author(s):  
Edivaldo Miotto ◽  
Karina Maria Salvatore Freitas ◽  
Aline Akemi Mori ◽  
Fabricio Pinelli Valarelli ◽  
Ricardo Cesar Gobbi de Oliveira ◽  
...  

Aim: This prospective controlled clinical study aimed to evaluate the effect of botulinum toxin Type A (BTX-A) on pain control and quality of life (QoL) in patients with chronic myofascial pain. Materials & methods: Patients with chronic myofascial pain were randomly divided into two groups (n = 20): counseling and self-care and Michigan-type occlusal splint (MOS) (CG-control group) or BTX-A injection (BTX-AG). The pain was evaluated with visual analogue scale and QoL with the oral health impact profile-14 (OHIP-14) questionnaire. Results: In both groups, the pain was reduced, and QoL improved after 30 days. The results of social disability and handicap were better for patients treated with counseling and self-care and MOS. Conclusion: Minimally invasive strategies and BTX-A application improved QoL and alleviated myofascial pain.


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