Reduction in Pain and Pain Intensity with Nonpharmacological Treatment in Severely Obese Patients: A Randomized Clinical Trial.
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SUBMITTER: Mendonca CR
PROVIDER: S-EPMC8582684 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThere are few studies in the literature about the effect of obturation techniques on postoperative pain. Besides, GuttaFlow2 was used for the first time in this study regarding postoperative pain. This study aimed to compare the postoperative pain levels and incidence following single-visit root canal treatment with different canal filling techniques; cold lateral compaction (CLC), thermoplasticised solid-core carrier (GuttaCore) based filling and cold free-flow compaction (GuttaFlow2) technique.MethodsThe patients (n = 93) having single-rooted teeth with a single canal diagnosed with asymptomatic irreversible pulpitis or single-rooted vital teeth with a single canal requiring endodontic treatment because of prosthetic reasons were enrolled in this study. Patients were randomized into three groups (n = 31) according to the obturation technique. A single operator performed all the treatments in a single visit. Data on obturation levels, postoperative pain and analgesic intake frequency were recorded at postoperative 6, 12 and 24 h and daily afterward until the 7th day. Postoperative pain was measured by visual analogue scale (VAS). The date were statistically analyzed with chi-squared tests (for the analyses of the categorical data), the nonparametric Kruskal-Wallis test (for the comparisons of VAS score) and with the Friedman test (for the assessments of the changes in VAS scores over time).ResultsThe GuttaCore group recorded the higher pain levels, except first 12 h, on the other hand, the GuttaFlow2 group recorded the lower pain levels at all time periods. Significant differences occurred among the groups during the first 4 days (p < 0.05), except at 12 h (p = 0.054). The patients in the CLC and GuttaFlow2 groups did not need to use the prescribed analgesic; however, one patient in the GuttaCore group used it once.ConclusionsPostoperative pain levels following root canal therapy were affected by the obturation technique especially first 4 days following obturation.
| S-EPMC9338753 | biostudies-literature
Project description:BACKGROUND:Inspiratory resistive breathing (IRB) challenges affect respiratory muscle endurance in healthy individuals, which is considered to be an interleukin 6 (IL-6)-dependent mechanism. Whether nonpharmacological thermal therapies promote the endurance of loaded inspiratory muscles in chronic obstructive pulmonary disease (COPD) is unclear. The objectives of this study were to compare the effects of two thermal interventions on endurance time (ET) and plasma IL-6 concentration following an IRB challenge. METHODS:This study was a randomized, parallel-group, unblinded clinical trial in a single-center setting. Forty-two patients (aged 42-76 years) suffering from mild to severe COPD participated in this study. Both groups completed 12 sessions of the mud bath therapy (MBT) (n=22) or leisure thermal activity (LTA) (n=19) in a thermal spa center in Italy. Pre- and postintervention spirometry, maximum inspiratory pressure, and plasma mediators were obtained and ET and endurance oxygen expenditure (VO2Endur) were measured following IRB challenge at 40% of maximum inspiratory pressure. RESULTS:There was no difference in ?IL-6 between the intervention groups. But, IRB challenge increased cytokine IL-6 plasma levels systematically. The effect size was small. A statistically significant treatment by IRB challenge effect existed in ET, which significantly increased in the MBT group (P=0.003). In analysis of covariance treatment by IRB challenge analysis with LnVO2Endur as the dependent variable, ?IL-6 after intervention predicted LnVO2Endur in the MBT group, but not in the LTA group. Adverse events occurred in two individuals in the MBT group, but they were mainly transient. One patient in the LTA group dropped out. CONCLUSION:MBT model improves ET upon a moderate IRB challenge, indicating the occurrence of a training effect. The LnVO2Endur/?IL-6 suggests a physiologic adaptive mechanism in respiratory muscles of COPD patients allocated to treatment. Both thermal interventions are safe.
| S-EPMC4629956 | biostudies-literature
Project description:A 56-week randomized controlled trial was conducted to evaluate safety and efficacy of a controlled-release combination of phentermine and topiramate (PHEN/TPM CR) for weight loss (WL) and metabolic improvements. Men and women with class II and III obesity (BMI ? 35 kg/m(2)) were randomized to placebo, PHEN/TPM CR 3.75/23 mg, or PHEN/TPM CR 15/92 mg, added to a reduced-energy diet. Primary end points were percent WL and proportions of patients achieving 5% WL. Secondary end points included waist circumference (WC), systolic and diastolic blood pressure (BP), fasting glucose, and lipid measures. In the primary analysis (randomized patients with at least one postbaseline weight measurement who took at least one dose of assigned drug or placebo), patients in the placebo, 3.75/23, and 15/92 groups lost 1.6%, 5.1%, and 10.9% of baseline body weight (BW), respectively, at 56 weeks (P < 0.0001). In categorical analysis, 17.3% of placebo patients, 44.9% of 3.75/23 patients, and 66.7% of 15/92 patients, lost at least 5% of baseline BW at 56 weeks (P < 0.0001). The 15/92 group had significantly greater changes relative to placebo for WC, systolic and diastolic BP, fasting glucose, triglycerides, total cholesterol, low-density lipoprotein (LDL), and high-density lipoprotein (HDL). The most common adverse events were paresthesia, dry mouth, constipation, dysgeusia, and insomnia. Dropout rate from the study was 47.1% for placebo patients, 39.0% for 3.75/23 patients, and 33.6% of 15/92 patients. PHEN/TPM CR demonstrated dose-dependent effects on weight and metabolic variables in the direction expected to be beneficial with no evidence of serious adverse events induced by treatment.
| S-EPMC3270297 | biostudies-literature
Project description:Purpose:The aim of this study was to investigate the effect of Photobiomodulation (PBM) in managing orthodontic pain intensity over time in patients requiring band application on upper first molars. Methods:Maxillary first molars were banded. In the trial group, each molar received single-session PBM on two buccal and two palatal points (? = 830 ± 10?nm; 150?mW, 7.5?J/cm2; spot of 0.1?cm2; 5?sec per point), while the control group received a placebo treatment. All patients were asked to answer five pain rating scales to assess pain intensity at 5 minutes and 1, 12, 24, and 72 hours and completed a survey describing the type of pain and its temporal course in the next 7 days. Results:26 patients (mean age 11.8 years) were randomly assigned to a control or a trial group. The trial group showed significantly lower pain intensities (p < 0.05) at 5?min (M = 0.92, SD = 1.32), 1?h (M = 0.77, SD = 1.01), and 12?h (M = 0.77, SD = 1.54) after band application compared to the control group (5?min: M = 1.62, SD = 1.26; 1?h: M = 1.77, SD = 1.92; and 12?h: M = 1.77, SD = 2.17), whereas no difference between groups (p > 0.05) was found at 24?h (trial: M = 0.62, SD = 1.71; control: M = 1.08, SD = 1.75) and 72?h (trial: M = 0.31, SD = 0.75; control: M = 0.15, SD = 0.55). Patients in the control group reported more frequently the presence of "compressive pain" (58.8%, p < 0.05) from the appliance during the week after the application, while the trial group showed higher frequency of "no pain" (46.2%, p < 0.05). However, PBM did not affect the pain onset (trial: M = 10.86, SD = 26.97; control: M = 5.25, SD = 7.86), peak (trial: M = 15.86, SD = 26.29; control: 6.17, SD = 7.96), and end time (trial: 39.57, SD = 31.33; control: M = 22.02, SD = 25.42) reported by the two groups (p > 0.05). Conclusions:PBM might be considered a promising alternative to decrease general pain intensity, although not affecting the typical pain cycle, in terms of the onset, peak, and ending times.
| S-EPMC7273483 | biostudies-literature
Project description:ImportanceImproved strategies are needed to decrease opioid use after cesarean delivery but still adequately control postoperative pain. Although transcutaneous electrical stimulation devices have proven effective for pain control after other surgical procedures, they have not been tested as part of a multimodal analgesic protocol after cesarean delivery, the most common surgical procedure in the United States.ObjectiveTo determine whether treatment with a noninvasive high-frequency electrical stimulation device decreases opioid use and pain after cesarean delivery.Design, setting, and participantsThis triple-blind, sham-controlled randomized clinical trial was conducted from April 18, 2022, to January 31, 2023, in the labor and delivery unit at a single tertiary academic medical center in Ohio. Individuals were eligible for the study if they had a singleton or twin gestation and underwent a cesarean delivery. Of 267 people eligible for the study, 134 (50%) were included.InterventionParticipants were randomly assigned in a 1:1 ratio to a high-frequency (20 000 Hz) electrical stimulation device group or to an identical-appearing sham device group and received 3 applications at the incision site in the first 20 to 30 hours postoperatively.Main outcomes and measuresThe primary outcome was inpatient postoperative opioid use, measured in morphine milligram equivalents (MME). Secondary outcomes included pain scores, measured with the Brief Pain Inventory questionnaire (scale, 0-10, with 0 representing no pain), MME prescribed at discharge, and receipt of additional opioid prescriptions in the postpartum period. Normally distributed data were assessed using t tests; otherwise via Mann-Whitney or χ2 tests as appropriate. Analyses were completed following intention-to-treat principles.ResultsOf 134 postpartum individuals who underwent a cesarean delivery (mean [SD] age, 30.5 [4.6] years; mean [SD] gestational age at delivery, 38 weeks 6 days [8 days]), 67 were randomly assigned to the functional device group and 67 to the sham device group. Most were multiparous, had prepregnancy body mass index (calculated as weight in kilograms divided by height in meters squared) higher than 30, were privately insured, and received spinal anesthesia. One participant in the sham device group withdrew consent prior to treatment. Individuals assigned to the functional device used significantly less opioid medication prior to discharge (median [IQR], 19.75 [0-52.50] MME) than patients in the sham device group (median [IQR], 37.50 [7.50-67.50] MME; P = .046) and reported similar rates of moderate to severe pain (85% vs 91%; relative risk [RR], 0.77 [95% CI, 0.55-1.29]; P = .43) and mean pain scores (3.59 [95% CI, 3.21-3.98] vs 4.46 [95% CI, 4.01-4.92]; P = .004). Participants in the functional device group were prescribed fewer MME at discharge (median [IQR], 82.50 [0-90.00] MME vs 90.00 [75.00-90.00] MME; P < .001). They were also more likely to be discharged without an opioid prescription (25% vs 10%; RR, 1.58 [95% CI, 1.08-2.13]; P = .03) compared with the sham device group. No treatment-related adverse events occurred in either group.Conclusions and relevanceIn this randomized clinical trial of postoperative patients following cesarean delivery, use of a high-frequency electrical stimulation device as part of a multimodal analgesia protocol decreased opioid use in the immediate postoperative period and opioids prescribed at discharge. These findings suggest that the use of this device may be a helpful adjunct to decrease opioid use without compromising pain control after cesarean delivery.
| S-EPMC10589807 | biostudies-literature
Project description:BACKGROUND:Obesity is associated with impaired health and lower work ability. Increased physical activity is a cornerstone in the treatment of obesity and related risk factors. Recently, high-intensity interval training (HIIT) has emerged as a popular exercise option. However, data regarding the effects on cardiometabolic health, perceived work ability and well-being in severely obese individuals are lacking. METHODS:Sixty-five obese individuals with sedentary occupation (48.7?±?9.9 years, BMI: 39.6?±?7.1 kg/m2) were randomly allocated to an extremely time-efficient HIIT (5?×?1 min at 80-95% maximal heart rate on cycle ergometers, 2×/week for 12 weeks) or an inactive control group (CON). Both groups received nutritional counseling to support weight loss. Primary outcome was maximal oxygen uptake (VO2max), secondary outcomes were cardiometabolic risk indices, body composition, work ability index (WAI), quality of life (QoL, EQ-5D-5L-questionnaire) and perceived stress (PSQ-questionnaire). RESULTS:Mean body weight reduction was 5.3 kg [95% confidence interval (95% CI) -?7.3 to -?3.3 kg] in the HIIT group (P?<?0.001) and 3.7 kg (95% CI -?5.3 to -?2.1 kg) in CON (P?<?0.001), respectively. Only the HIIT group showed significant (P?<?0.001) changes in VO2max [+?3.5 mL/kg/min (95% CI 2.5 to 4.6 mL/kg/min)], waist circumference [-7.5 cm (95% CI -?9.8 to -?5.1 kg)], mean arterial blood pressure [-?11 mmHg (95% CI -?14 to -?8 mmHg)], WAI [+?3.0 points (95% CI 1.7 to 4.3 points)] and QoL [+?10% (95% CI 5 to 16%)]. In CON, none of these parameters improved significantly. CONCLUSIONS:Low-volume HIIT may induce significant improvements in cardiometabolic health, especially VO2max, WAI and well-being in obese individuals after only 12 weeks. Our results underpin the wide range of benefits on health and subjective measures through exercise that go well beyond simple weight loss through dietary restriction alone. TRIAL REGISTRATION:ClinicalTrials.gov Id: NCT03306069. Registered 10 October 2017, https://clinicaltrials.gov/ct2/show/NCT03306069 .
| S-EPMC7648946 | biostudies-literature
Project description:PurposeLow-intensity continuous ultrasound (LICUS) is an emerging high-dosimetry ultrasound-based therapy for accelerated tissue healing and the treatment of myofascial pain. In this study, LICUS treatment is clinically evaluated for chronic upper neck and shoulder pain in a randomized, multi-site, double-blind, placebo-controlled study.Patients and methodsCONSORT guidelines were followed in conducting and reporting the clinical trial. Thirty-three participants with upper trapezius myofascial pain were randomized for treatment with active (n=25) or placebo (n=8) devices. Investigators and subjects were blinded to treatment groups. Participants self-reported pain daily, rating from 0-10 on the numeric rating scale. If pain rating was more significant than or equal to 3, the LICUS (3MHz, 0.132W/cm2, 1.3W, 4 hours) was self-applied for total energy dosimetry of 18,720 Joules per treatment. During the 4-week study, daily pain rating was recorded. If LICUS treatment was delivered, pain before, during, and after treatment were recorded as well as the global rate of change (GROC). Independent t-tests were used to assess change from baseline and differences between treatment groups. ClinicalTrials.gov: NCT02135094.ResultsThere was a 100% completion rate for participants enrolled in the study and no significant differences between the groups regarding demographic variables or baseline outcome measures. Participants treated with active therapy observed a significant mean pain reduction from baseline of 2.61 points for active (p<0.001), compared to 1.58 points decrease from baseline for placebo (p=0.087), resulting in a 1.03 points significant decrease in the active group over placebo (p=0.003). The total GROC was significantly higher in the active group at 2.84 points compared to the placebo group at 0.46 points (p<0.001).ConclusionLow-intensity continuous ultrasound treatment significantly reduced pain in patients with upper trapezius myofascial pain of the neck and shoulder. LICUS treatment showed a clinically meaningful improvement in the GROC scores for patients. The results from this clinical trial indicate that the LICUS treatment of 18,720 Joules can effectively be used to treat clinical pain related to upper trapezius myofascial pain. Further research could investigate varying dosimetry to improve efficacy and/or reduce the dose.
| S-EPMC7287226 | biostudies-literature
Project description:Mounting evidence supports the importance of hormonal fluctuations in temporomandibular disorder (TMD) pain among women. Stabilizing influential hormones or having a plan and skills for coping with hormonally related increases in TMD pain, therefore, may be beneficial for women with TMD pain. This randomized clinical trial evaluated the short- and long-term efficacy of 3 interventions for women with TMD pain: (1) dental hygienist-delivered pain self-management training (SMT; n=59); (2) the same dental hygienist-delivered pain self-management training, but with a focus on menstrual cycle-related changes in pain and other symptoms (targeted SMT, or TSMT; n=55); and (3) continuous oral contraceptive therapy (6-month trial) aimed at stabilizing hormones believed to be influential in TMD pain (COCT; n=57). Study participants completed outcome (pain, activity interference, depression) and process (pain beliefs, catastrophizing, coping effectiveness) measures before randomization, and 6 and 12months later. Intent-to-treat analyses supported the benefits of the SMT and TSMT interventions relative to COCT. Targeting the self-management treatment to menstrual cycle-related symptoms did not increase the treatment's efficacy. The benefits of the self-management interventions relative to COCT for pain and activity interference were statistically significant at 12 months, but not at 6 months, whereas the benefits for the process measures generally were apparent at both time points. COCT was associated with multiple adverse events (none serious). The study provides further support for long-term benefits of a safe, low-intensity (2 in-person sessions and 6 brief telephone contacts), dental hygienist-delivered self-management treatment for TMD pain.
| S-EPMC3157596 | biostudies-literature
Project description: Not available
| S-EPMC4907437 | biostudies-literature
Project description:BackgroundPrevious intervention studies have reported the association of the PPARG2 Pro12Ala (rs1801282) and IL6 -174G > C (rs1800795) polymorphisms with weight loss; however, their results are inconsistent. We aimed to investigate the effect of the PPARG2 Pro12Ala and IL6 -174G > C polymorphisms on body weight, body composition and metabolic parameters after a 12-week nutritional intervention with a traditional Brazilian diet and extra virgin olive oil supplementation in severely obese patients.MethodsA total of 149 severely obese individuals [body mass index (BMI) ≥ 35 kg/m2] were randomized into three 12-week nutritional intervention groups - the extra virgin olive oil supplementation (OO) group (n = 50), the traditional Brazilian diet (DieTBra) group (n = 49), and the DieTBra plus extra virgin olive oil supplementation (DieTBra+OO) group (n = 50). Anthropometric measurements, body composition, metabolic parameters, physical activity practise and dietary intake were assessed. The associations were tested using generalized linear models adjusted for confounders.ResultsThe PPARG2 Pro12Ala polymorphism influenced body composition changes. Ala carriers in the intervention groups with extra virgin olive oil supplementation had greater reductions in the percentage of body fat (%BF) (OO: p = 0.049, DietBra+OO: p = 0.004) and greater increases in both fat-free mass (FFM) (OO: p = 0.020, DieTBra: p = 0.007) and lean mass (LM) (OO: p = 0.020, DieTBra+OO: p = 0.007) than did ProPro homozygotes. No association was found for the IL6 -174G > C polymorphism.ConclusionsExtra virgin olive oil intake may modulate favourable body composition changes, promoting a decrease in the %BF and increases in the LM and FFM of severely obese individuals, even without weight loss, in the presence of the Ala allele of the Pro12Ala polymorphism.Trial registrationRegistered under ClinicalTrials.gov Identifier No. NCT02463435.
| S-EPMC6050653 | biostudies-literature