2. Universidad Cardenal Herrera-CEU

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    How much is needed?: comparison of the effectiveness of different pain education dosages in patients with fibromyalgia2020-04

    Objective: To assess the effect of different dosages of pain neuroscience education (PNE) programs on central nociceptive processing in patients with fibromyalgia. Second, to compare the effects of different dosages of PNE programs on numerical pain rating scale (NPRS), disability, and psychological variables. Design: Single-blind randomized controlled trial. Setting: Three fibromyalgia centers in Spain (Valencia, Alcorcón, Alcalá de Henares). Subjects: Seventy-seven patients with fibromyalgia. Methods: Participants were randomized to four groups of PNE: 1) high-dose PNE (N = 20), 2) low-concentrated dose PNE (N = 20), 3) diluted low-dose PNE (N = 20), and (4) control treatment (N = 17), conducted in two 30-50-minute sessions in groups of four to six participants. Conditioned pain modulation (CPM), temporal summation (TS), and pressure pain thresholds (PPTs) were assessed at baseline and at three-month follow-up. Secondary outcome measures were the Fibromyalgia Impact Questionnaire, Pain Catastrophizing Scale, and Pain Anxiety Symptoms Scale. Results: There were significant between-group differences for NPRS in favor of the groups receiving high-dose PNE, with a large effect size at three-month follow-up (P < 0.01, η2p = 0.170), but there were no significant differences between groups for the remaining variables (P > 0.05). All groups improved for central nociceptive processing, psychological variables, disability, and pain intensity (NPRS). Conclusions: In patients with fibromyalgia, higher dosages of PNE produced a larger improvement in pain severity at three-month follow-up than other dosages of PNE and biomedical education. However, PNE was not superior to biomedical education in the central nociceptive processing, disability, or psychological variables in patients with fibromyalgia.

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    Effectiveness of a supervised group-based Otago Exercise Program on functional performance in frail institutionalized older adults: a multicenter randomized controlled trial2023-01

    Background and purpose: Because of its high prevalence and association with negative health-related outcomes, frailty is considered one of the most important issues associated with human aging and its mitigation is among the essential public health goals for the 21st century. However, very few studies have focused on institutionalized older adults, despite the knowledge that frailty can be reversible when identified and treated from its earliest stages. Therefore, the objective of this study was to evaluate the effects of a supervised group-based multicomponent exercise program intervention with or without oral nutritional supplementation on functional performance in frail institutionalized older adults. Methods: This was a multicenter randomized controlled trial study with a 6-month intervention period. A total of 111 frail institutionalized older adults (75 years or older) who met at least 3 of the 5 Fried frailty criteria were randomly allocated to the control group (CG; n = 34, mean age = 87.3 ± 5.3 years), a supervised group-based multicomponent Otago Exercise Program group (OEP; n = 39, mean age = 86 ± 5.9 years), or a supervised group-based multicomponent exercise program intervention with oral nutritional supplementation (OEP+N; n = 38, mean age = 84.9 ± 6 years). Measurements included the Timed Up and Go test (TUG), Berg Balance Scale (BBS), Short Physical Performance Battery, repeated chair stand test (STS-5), handgrip strength (HGS), 10-m walking test, and 6-minute walking test, both at baseline and after the 6-month intervention period. Results and discussion: The between-group analysis by 2-way analysis of covariance showed significant improvement in the TUG [{OEP vs CG: -8.2 seconds, 95% CI [-13.3 to -2.9]; P < .001}; {OEP vs OEP+N: -7.3 seconds, 95% CI [-12.4 to -2.2]; P = .002}], BBS [{OEP vs CG; 8.2 points, 95% CI [5.2 to 11.2]; P < .001}; [{OEP+N vs CG: 4.6 points, 95% CI [1.6 to 7.6]; P < .001}; {OEP vs OEP+N: 3.5 points, 95% CI [0.6 to 6.5]; P = .011}], and HGS [{OEP vs CG: 3.4 kg, 95% CI [1.5 to 5.3]; P < .001}; {OEP+N vs CG: 3.6 kg, 95% CI [1.7 to 5.5]; P < .001}]. Additionally, the within-group analysis showed a significant improvement in the TUG (-6.9 seconds, 95% CI [-9.8 to -4.0]; P < .001) and BBS (4.3 points, 95% CI [2.6 to 5.9]; P < .001) in the OEP group. A significant decrease in the BBS and HGS was shown in the CG. Conclusions: A 6-month supervised group-based multicomponent exercise intervention improved the levels of mobility, functional balance, and HGS in frail institutionalized older adults. Further research will be required to evaluate the nutritional supplementation effects on functional performance to better determine its clinical applicability for tackling frailty.

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    Transcutaneous nerve stimulation for pain relief during office hysteroscopy: a randomized controlled trial2017-02-01

    OBJECTIVE: To evaluate the pain-relieving effect of transcutaneous electrical nerve stimulation (TENS) during office-based hysteroscopy without sedation. METHODS: We conducted a randomized, double-blind, placebo-controlled trial. Participants were randomly assigned to the active TENS, placebo TENS, or control group. The active TENS intervention consisted of a varying high-frequency (80–100 Hz), 400-microseconds, individually adjusted, high-intensity TENS application with two self-adhesive electrodes placed parallel to the spinal cord at the T10–L1 and S2–S4 levels. In the placebo group, participants were connected to the TENS unit but delivering no electrical stimulation. The primary outcome was self-reported pain intensity (0–100 mm) measured on a visual analog scale at several stages (entry, contact, biopsy, and residual). The minimum clinically relevant difference for the visual analog scale has been previously reported as 10 mm. Sample size was calculated to provide 80% power to show a 10-mm difference (α=0.0125) in the primary outcome. Secondary outcomes included duration of the procedure, vital parameters, vasovagal symptoms, and participant satisfaction index (0–10 rating scale). RESULTS: A total of 138 women (46 per group) participated in the study between January 2016 and April 2016. No differences were found between groups regarding age, weight, body mass index, parity status, menopausal status, or previous hysteroscopy status. Visual analog scale scores highlighted a decrease in pain in the active TENS group compared with the placebo group (entry: −11 mm, 95% confidence interval [CI] −17 to −5; contact: −21.9 mm, 95% CI −30 to −13.9; biopsy: −30.5 mm, 95% CI −47.1 to −13.8, P<.001). Moreover, the reduction in pain reached the minimum clinically relevant difference. Regarding satisfaction, results also revealed differences between active TENS and placebo groups (1.3, 95% CI 0.5–2.2, P=.001). CONCLUSION: Transcutaneous electrical nerve stimulation reduces pain and increases patient satisfaction during office hysteroscopy without sedation.