A twelve‐week, four‐arm, randomized, double‐blind, placebo‐controlled, phase 2 prospective clinical trial to evaluate the efficacy and safety of an anthroposophic multimodal treatment on chronic pain in outpatients with postpolio syndrome
| العنوان: | A twelve‐week, four‐arm, randomized, double‐blind, placebo‐controlled, phase 2 prospective clinical trial to evaluate the efficacy and safety of an anthroposophic multimodal treatment on chronic pain in outpatients with postpolio syndrome |
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| المؤلفون: | Acary Souza Bulle Oliveira, Ricardo Ghelman, Vera Orgolini, Valeria T de Souza, Jussara Falcão, Abrahão Augusto Juviniano Quadros, Ivete Y Akiyama, Jorge Kioshi Hosomi |
| المصدر: | Brain and Behavior Brain and Behavior, Vol 10, Iss 4, Pp n/a-n/a (2020) |
| بيانات النشر: | John Wiley and Sons Inc., 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Male, medicine.medical_treatment, Behavioral Neuroscience, 0302 clinical medicine, Quality of life, Surveys and Questionnaires, Outpatients, neurodegenerative diseases, pain, Prospective Studies, Original Research, Pain Measurement, Analgesics, 05 social sciences, Chronic pain, Multimodal therapy, Middle Aged, Resilience, Psychological, Combined Modality Therapy, Treatment Outcome, Materia Medica, Female, Chronic Pain, Adult, medicine.medical_specialty, Visual analogue scale, Analgesic, Placebo, 050105 experimental psychology, lcsh:RC321-571, 03 medical and health sciences, Young Adult, Double-Blind Method, Anthroposophic medicine, medicine, Humans, 0501 psychology and cognitive sciences, lcsh:Neurosciences. Biological psychiatry. Neuropsychiatry, business.industry, Art Therapy, medicine.disease, postpolio syndrome, Clinical trial, Physical therapy, anthroposophic medicine, Quality of Life, Postpoliomyelitis Syndrome, business, 030217 neurology & neurosurgery, motor system |
| الوصف: | Introduction Chronic pain and fatigue are the main symptoms of postpoliomyelitis syndrome (PPS). This study aimed to evaluate the efficacy and safety of an anthroposophic multimodal treatment for chronic pain in PPS outpatients. Methods A twelve‐week, four‐arm, randomized, double‐blind, placebo‐controlled, phase 2 prospective clinical trial was designed to compare four groups (n = 48): groups A and B received daily active experimental transdermal gel (ETG) or placebo gel (PTG), respectively; groups C and D received weekly external therapies, art therapies, and neurofunctional reorganization, plus either daily ETG or PTG, respectively. The pain symptoms were evaluated through a visual analogue scale (VAS), the McGill questionnaire, and thermography. Quality of life and resilience were evaluated by the WHOQOL‐BREF and Antonovsky sense of coherence questionnaires applied at baseline and after the interventions. Results No related adverse events occurred, and 10% of the patients reports dysphagia improvement. In the groups C and D, pain reduction was statistically significant in both the placebo group (p = .02, d = 1.315) and in the ETG (p = .005, d = 2.035). However, following the week‐to‐week evolution of pain with the concomitant use of the ETG, this significant pain reduction occurred earlier from the 4th week and continued to decrease (p = .016, d = 1.369). In the group that received the complete multimodal treatment, the greatest significant benefit in increasing quality of life occurred in the physical domain and elevation in resilience with an emphasis on meaning and comprehension domains. Conclusions The anthroposophic multimodal treatment group presented both safety and efficacy as an analgesic in the groups that received the nonpharmacological therapies, much earlier when associated with the ETG. The multimodal approach corresponded to the pattern of better efficacy for both pain reduction and improvement in quality of life and resilience. This study aimed to evaluate the efficacy and safety of an anthroposophic multimodal treatment for muscle and joint chronic pain in outpatients with PPS. This twelve‐week, four‐arm, parallel, randomized, double‐blind, placebo‐controlled clinical trial which were applied to evaluate pain, quality of life and resilience at baseline and after the interventions. The treatment showed increased safety and efficacy for pain and improvement of the quality of life and resilience specially in the groups that received the nonpharmacological interventions, earlier when associated to transdermal gel. |
| اللغة: | English |
| تدمد: | 2162-3279 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bfd2e35b238ca24eed1edac12b9f3c37Test http://europepmc.org/articles/PMC7177555Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....bfd2e35b238ca24eed1edac12b9f3c37 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 21623279 |
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