دورية أكاديمية
أعرض في EDS

Effects of Transcranial Direct Current Stimulation on Knee Osteoarthritis Pain in Elderly Subjects With Defective Endogenous Pain-Inhibitory Systems: Protocol for a Randomized Controlled Trial.

التفاصيل البيبلوغرافية
العنوان: Effects of Transcranial Direct Current Stimulation on Knee Osteoarthritis Pain in Elderly Subjects With Defective Endogenous Pain-Inhibitory Systems: Protocol for a Randomized Controlled Trial.
المؤلفون: Tavares DRB; Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, Sao Paulo, Brazil.; Department of Geriatrics and Gerontology, Federal University of São Paulo, Sao Paulo, Brazil., Okazaki JEF; Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, Sao Paulo, Brazil.; Department of Geriatrics and Gerontology, Federal University of São Paulo, Sao Paulo, Brazil., Rocha AP; Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, Sao Paulo, Brazil., Santana MVA; Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, Sao Paulo, Brazil.; Department of Geriatrics and Gerontology, Federal University of São Paulo, Sao Paulo, Brazil., Pinto ACPN; Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, Sao Paulo, Brazil.; Department of Biological and Health Sciences, Federal University of Amapá, Amapá, Brazil., Civile VT; Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, Sao Paulo, Brazil.; Institute of Health Sciences, Paulista University, Sao Paulo, Brazil., Santos FC; Department of Geriatrics and Gerontology, Federal University of São Paulo, Sao Paulo, Brazil., Fregni F; Laboratory of Neuromodulation & Center for Clinical Research Learning, Physics and Rehabilitation Department, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, United States., Trevisani VFM; Department of Evidence-Based Medicine, Brazilian Cochrane Centre, Federal University of São Paulo, Sao Paulo, Brazil.; Department of Rheumatology, Santo Amaro University, Sao Paulo, Brazil.
المصدر: JMIR research protocols [JMIR Res Protoc] 2018 Oct 29; Vol. 7 (10), pp. e11660. Date of Electronic Publication: 2018 Oct 29.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: JMIR Publications Country of Publication: Canada NLM ID: 101599504 Publication Model: Electronic Cited Medium: Print ISSN: 1929-0748 (Print) Linking ISSN: 19290748 NLM ISO Abbreviation: JMIR Res Protoc Subsets: PubMed not MEDLINE
أسماء مطبوعة: Original Publication: Toronto : JMIR Publications
مستخلص: Background: Knee osteoarthritis (OA) has been the main cause behind chronic pain and disabilities in the elderly population. The traditional treatment for knee OA pain currently concerns a number of combinations of pharmacological and nonpharmacological therapies. However, such combinations have displayed little effects on a significant group of subjects. In addition to this, pharmacological treatments often cause adverse effects, which limits their use on this population. Previous studies showed that chronic knee OA pain may be associated with maladaptive compensatory plasticity in pain-related neural central circuits indexed by a defective descending pain-inhibitory system. Transcranial direct current stimulation (tDCS) can revert some of these maladaptive changes, thus decreasing chronic pain sensation. Numerous studies have demonstrated that the use of anodal tDCS stimulation over the primary motor cortex (M1) has positive effects on chronic neuropathic pain. Yet, data on OA pain in elderly patients, including its effects on the endogenous pain-inhibitory system, remain limited.
Objective: The objective of this study is to evaluate the efficacy of tDCS in reducing pain intensity caused by knee OA in elderly subjects with defective endogenous pain-inhibitory systems.
Methods: We designed a randomized, sham-controlled, single-center, double-blinded clinical trial. Patients with knee OA who have maintained a chronic pain level during the previous 6 months and report a pain score of 4 or more on a 0-10 numeric rating scale (NRS) for pain in that period will undergo a conditioned pain modulation (CPM) task. Participants who present a reduced CPM response, defined as a decrease in NRS during the CPM task of less than 10%, and meet all of the inclusion criteria will be randomly assigned to receive 15 sessions of 2 mA active or sham tDCS for 20 minutes. A sample size of 94 subjects was calculated. The Brief Pain Inventory pain items will be used to assess pain intensity as our primary outcome. Secondary outcomes will include pain impact on functioning, mobility performance, quality of life, CPM, pressure pain threshold, touch-test sensory evaluation, and safety. Follow-up visits will be performed 2, 4, and 8 weeks following intervention. The data will be analyzed using the principle of intention-to-treat.
Results: This study was approved by the institutional review board with the protocol number 1685/2016. The enrollment started in April 2018; at the time of publication of this protocol, 25 subjects have been enrolled. We estimate we will complete the enrollment process within 2 years.
Conclusions: This clinical trial will provide relevant data to evaluate if anodal tDCS stimulation over M1 can decrease chronic knee OA pain in elderly subjects with defective CPM. In addition, this trial will advance the investigation of the role of central sensitization in knee OA and evaluate how tDCS stimulation may affect it.
Trial Registration: ClinicalTrials.gov NCT03117231; https://clinicaltrials.gov/ct2/show/NCT03117231 (Archived by WebCite at http://webcitation.org/73WM1LCdJ).
International Registered Report Identifier (irrid): RR1-10.2196/11660.
(©Daniela Regina Brandao Tavares, Jane Erika Frazao Okazaki, Aline Pereira Rocha, Marcia Valeria De Andrade Santana, Ana Carolina Pereira Nunes Pinto, Vinicius Tassoni Civile, Fania Cristina Santos, Felipe Fregni, Virginia Fernandes Moça Trevisani. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 29.10.2018.)
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فهرسة مساهمة: Keywords: chronic pain; conditioned pain modulation; elderly; knee osteoarthritis; transcranial direct current stimulation
سلسلة جزيئية: ClinicalTrials.gov NCT03117231
تواريخ الأحداث: Date Created: 20181031 Latest Revision: 20201001
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC6234349
DOI: 10.2196/11660
PMID: 30373731
قاعدة البيانات: MEDLINE
الوصف
تدمد:1929-0748
DOI:10.2196/11660