Dataset Information

Effects of Monopolar Dielectric Radiofrequency Signals on the Symptoms of Fibromyalgia: A Single-Blind Randomized Controlled Trial.

ABSTRACT: Monopolar dielectric radiofrequency (MDR) is a non-invasive treatment for pain based on the local application of electromagnetic signals. The study's goal was to analyze the effects of MDR on the symptoms of fibromyalgia. For this aim, a randomized controlled trial was conducted on 66 female participants (aged 47 17.7) diagnosed with fibromyalgia. Participants were randomly allocated to either an experimental group (n = 23), which received eight 20-minute sessions of MDR; a sham group, which received the same number of sessions of a sham MDR therapy (n = 22); or a control group (n = 21), which received usual care. The outcome variables included pain measured by the visual analogue scale (VAS), score on the hospital anxiety and depression scale (HADS) and quality of life measured by the combined index of fibromyalgia severity (ICAF). A large effect size was observed for the local pain (R2 = 0.46), total ICAF (R2 = 0.42) and ICAF physical factor scores (R2 = 0.38). Significant mean differences were found for the local pain (p = 0.025) and ICAF physical factor (p = 0.031) scores of the experimental group in comparison with the sham group. No statistically significant differences between groups were found in HADS. In conclusion, MDR is more effective than either sham treatment or usual care in the short-term improvement of pain and the physical wellbeing of participants with fibromyalgia.

SUBMITTER: Ibanez-Vera AJ

PROVIDER: S-EPMC7177294 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Effects of Monopolar Dielectric Radiofrequency Signals on the Symptoms of Fibromyalgia: A Single-Blind Randomized Controlled Trial.

Ibáñez-Vera Alfonso Javier AJ García-Romero Jerónimo Carmelo JC Alvero-Cruz José Ramón JR Lomas-Vega Rafael R

International journal of environmental research and public health 20200403 7

Monopolar dielectric radiofrequency (MDR) is a non-invasive treatment for pain based on the local application of electromagnetic signals. The study's goal was to analyze the effects of MDR on the symptoms of fibromyalgia. For this aim, a randomized controlled trial was conducted on 66 female participants (aged 47 17.7) diagnosed with fibromyalgia. Participants were randomly allocated to either an experimental group (<i>n</i> = 23), which received eight 20-minute sessions of MDR; a sham group, wh ...[more]

PMID: 32260313

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Project description:ObjectiveThe aim of this study was to compare intraoperative blood loss, postoperative pain, post-tonsillectomy hemorrhage (PTH), and medical costs associated with extracapsular tonsillectomy between coblation and monopolar electrocautery in children.Materials and methodsThis study included 293 patients aged 6-15 years planned to undergo extracapsular tonsillectomy. Data on estimated blood loss, postoperative pain score, operation time, PTH, and the cost of disposable equipment were collected.ResultsCoblation extracapsular tonsillectomy was associated with significantly lower mean pain scores than monopolar technique on postoperative days 1 (p <.001) and 2 (p = 0.02). However, the pain score was similar between the groups at all other time points. The monopolar group had a significantly shorter operation time compared to the coblation group (11.09 ± 7.53 vs. 17.12 ± 4.29 min, p <.001). Intraoperative estimated blood loss was not significantly different between the groups (p = .43).The cost of extracapsular tonsillectomy was significantly lower in the monopolar compared to the coblation group (US$ 28.18 vs. US$ 430.48, p <.001). PTH occurred in 17 patients (5.80%) and required a second surgery. Secondary PTH occurred in 6.16% (9/146) and 0.68% (1/147) of patients in the coblation and monopolar groups, respectively (p <.001). The PTH was significantly higher in the tonsillitis compared to in the tonsillar hypertrophy (12.37% vs. 2.55%, p = .002), However, the difference of PTH was not significant among mean pain scores subgroups. Of the 17 patients with PTH, the lower pole, middle portion, and upper pole were involved in 15 (88.24%), 2 (11.76%), and 0 cases, respectively.ConclusionsCoblation and novel monopolar electrocautery extracapsular tonsillectomy are associated with similar postoperative pain scores except on postoperative days 1 and 2. However, monopolar technique offers significant advantages over coblation method with less operative time, decreased secondary PTH, and cost.Level of Evidence: NA.

Project description:IntroductionFibromyalgia is characterized by widespread pain and is often accompanied by accessory symptoms. There are limited treatment options for this condition in Japan. Therefore, we conducted a phase III study to assess the efficacy and safety of duloxetine in Japanese patients with fibromyalgia.MethodsThis randomized, double-blind, placebo-controlled, parallel-group trial was conducted in Japan. Outpatients who met the American College of Rheumatology 1990 criteria for fibromyalgia and whose Brief Pain Inventory (BPI) average pain score was ≥4 were randomized to duloxetine 60 mg or placebo once daily for 14 weeks. The primary efficacy measure was the change in the BPI average pain score from baseline. Secondary efficacy, quality of life (QoL), and safety outcomes were also evaluated. Mixed-effects model repeated-measures (MMRM) analysis and last observation carried forward (LOCF) analysis of covariance were used to evaluate the primary efficacy measure.ResultsOverall, 393 patients were randomized to receive either duloxetine (n = 196) or placebo (n = 197). The MMRM analysis revealed no significant difference between duloxetine and placebo regarding the change in BPI average pain scores at week 14. Based on LOCF analysis, a statistically significant improvement in the change in BPI average pain scores at week 14 was observed for patients treated with duloxetine compared with placebo. Duloxetine treatment was associated with improved outcomes in nearly all secondary and post hoc analyses. The treatment was generally well tolerated. Somnolence, nausea, and constipation were the most common treatment-emergent adverse events in the duloxetine group. The discontinuation rates due to treatment-emergent adverse events were similar in both groups.ConclusionsAlthough the MMRM analysis did not demonstrate superiority of duloxetine over placebo, duloxetine treatment was associated with improved outcomes in secondary and post hoc analyses of the mean change in the BPI average pain score and most of the secondary outcomes, including analgesia and QoL. Duloxetine treatment was safe and well tolerated. These results suggest that duloxetine treatment could be associated with improvements in pain relief and QoL in Japanese patients with fibromyalgia.Trial registrationClinicalTrials.gov Identifier: NCT01552057 . Registered 9 March 2012.

Dataset Information

Effects of Monopolar Dielectric Radiofrequency Signals on the Symptoms of Fibromyalgia: A Single-Blind Randomized Controlled Trial.

Publications

Effects of Monopolar Dielectric Radiofrequency Signals on the Symptoms of Fibromyalgia: A Single-Blind Randomized Controlled Trial.

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