Corrigendum to "A New Device Improves Signs and Symptoms of TMD".
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SUBMITTER: Monaco A
PROVIDER: S-EPMC7201844 | biostudies-literature | 2020
REPOSITORIES: biostudies-literature
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Corrigendum to "A New Device Improves Signs and Symptoms of TMD".
Monaco Annalisa A Pietropaoli Davide D Iapnor Cooper Barry C BC Ortu Eleonora E
Pain research & management 20200417
[This corrects the article DOI: 10.1155/2019/5646143.]. ...[more]
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Project description:BackgroundTemporomandibular joint dysfunction (TMD) therapy remains an open challenge for modern dentistry. Herein, we propose a new neuromuscular lingual device able to reduce signs and symptoms of TMD in female patients with chronic orofacial pain.Methods50 females with myofascial TMD according to RDC/TMD were randomly assigned to study (n = 25) and control groups (n = 25). At T0, both groups received sEMG/KNG and pain evaluation by the VAS scale. The study group received the ELIBA device (lingual elevator by Balercia) constructed under ULF-TENS (ultra-low-frequency transcoutaneous electrical nervous stimulation). Subjects were instructed to use ELIBA at least for 16 h/day. After 6 months (T1), both groups underwent to sEMG/KNG and VAS revaluation.ResultsT1 study group compared to controls showed a significant reduction in total (p < 0.0001) and mean (p < 0.0001) sEMG values, as well as a significant increase in both maximum vertical mouth opening (p=0.003) and maximum velocity in mouth opening (p=0.003) and closing (p < 0.0001). Interestingly, a significant reduction in pain measured by VAS (p < 0.0001) was reported.ConclusionsAfter 6 months, the ELIBA device is able to significantly reduce TMD-associated myogenous pain and to promote the enhancement of sEMG/KNG values.Practical implicationsELIBA can be considered as a new device, potentially useful for head-neck pain relief in patients suffering from chronic TMD. In addition, its use promotes a muscles relaxation inducing freeway space increase. This characteristic makes it particularly useful for rehabilitation of patients with not enough space for construction of conventional orthotics or neuromuscular bites.
| S-EPMC6526566 | biostudies-literature
Project description:ObjectivesTo evaluate further in a phase III, double blind trial the efficacy of infliximab in patients with active psoriatic arthritis (PsA), as observed in the smaller IMPACT trial.Methods200 patients with active PsA unresponsive to previous treatment were randomised to infusions of infliximab 5 mg/kg or placebo at weeks 0, 2, 6, 14, and 22. Patients with inadequate response entered early escape at week 16. The primary measure of clinical response was ACR20. Other measures included Psoriatic Arthritis Response Criteria (PsARC), Psoriasis Area and Severity Index (PASI), and dactylitis and enthesopathy assessments.ResultsAt week 14, 58% of patients receiving infliximab and 11% of those receiving placebo achieved an ACR20 response and 77% of infliximab patients and 27% of placebo patients achieved PsARC (both p<0.001). Among the 85% of patients with at least 3% body surface area psoriasis involvement at baseline, 53/83 (64%) patients receiving infliximab had at least 75% improvement in PASI compared with 2/87 (2%) patients receiving placebo at week 14 (p<0.001). These therapeutic effects were maintained through the last evaluation (week 24). Fewer infliximab patients than placebo patients had dactylitis at week 14 (18% v 30%; p = 0.025) and week 24 (12% v 34%; p<0.001). Fewer infliximab patients (22%) than placebo patients (34%) had active enthesopathy at week 14 (p = 0.016); corresponding figures at week 24 were 20% and 37% (p = 0.002). Infliximab was generally well tolerated, with a similar incidence of adverse events in each group.ConclusionsInfliximab 5 mg/kg through 24 weeks significantly improved active PsA, including dactylitis and enthesopathy, and associated psoriasis.
| S-EPMC1755609 | biostudies-literature
Project description:PurposeThe efficacy of levoketoconazole in treating hypercortisolism was demonstrated in an open-label phase 3 study (SONICS) of adults with endogenous Cushing's syndrome (CS) and baseline mean urinary free cortisol (mUFC) ≥ 1.5× ULN. Clinical signs and symptoms and patient-reported outcomes from the SONICS trial were evaluated in the current manuscript.MethodsPatients titrated to an individualized therapeutic dose entered a 6-month maintenance phase. Secondary endpoints included investigator-graded clinical signs and symptoms of CS during the maintenance phase, and patient-reported quality of life (CushingQoL questionnaire) and depression symptoms (Beck Depression Inventory II [BDI-II]).ResultsOf 94 enrolled patients, 77 entered the maintenance phase following individualized dose titration. Significant mean improvements from baseline were noted at end of maintenance (Month 6) for acne, hirsutism (females only), and peripheral edema. These improvements were observed as early as Day 1 of maintenance for hirsutism (mean baseline score, 7.8; ∆ - 1.9; P < 0.0001), end of Month 1 for acne (mean baseline score, 2.8; ∆ - 1.2; P = 0.0481), and Month 4 for peripheral edema (mean baseline score, 1.0; ∆ - 0.5; P = 0.0052). Significant mean improvements from baseline were observed by Month 3 of maintenance for CushingQoL (mean baseline score, 44.3; ∆ + 6.9; P = 0.0018) and at Month 6 for BDI-II (mean baseline score, 17.1; ∆ - 4.3; P = 0.0043) scores. No significant mean improvement was identified in a composite score of 7 other clinical signs and symptoms.ConclusionsTreatment with levoketoconazole was associated with sustained, meaningful improvements in QoL, depression, and certain clinical signs and symptoms characteristic of CS. ClinialTrials.gov identifier: NCT01838551.
| S-EPMC7864823 | biostudies-literature
Project description:Fibromyalgia (FM), classified by ICD-11 with code MG30.0, is a chronic debilitating disease characterized by wide-spread pain, fatigue, cognitive impairment, sleep and intestinal alterations, among other. FM affects a large proportion of the world-wide population, with increased prevalence among women. The lack of understanding of its etiology and pathophysiology hampers the development of effective treatments. Our group had developed a manual therapy (MT) pressure-controlled custom manual protocol on FM showing hyperalgesia/allodynia, fatigue and patient’s quality of life benefits in a cohort of 38 FM cases (NCT04174300). With the aim of understanding the therapeutic molecular mechanisms triggered by MT, this study interrogated PBMC transcriptomes from FM participants of this clinical trial using RNAseq and RT-qPCR technologies. The results showed that the salt-induced kinase SIK1 gene was consistently downregulated by MT in FM, correlating with improvement of patient symptoms. In addition, the study compared the findings in a non-FM control cohort subjected to the same MT protocol evidencing that changes in SIK1 expression with MT only occurred in individuals with FM. This positions SIK1 as a potential biomarker to monitor response to MT, and as a therapeutic target of FM, to be further explored by continuation studies. Keywords: fibromyalgia; myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS); pressure point threshold (PPT); physiotherapy; manual therapy (MT); NCT04174300; SIK1
2024-09-11 | GSE274134 | GEO
Project description:PurposeTo assess the prophylactic and treatment activity of reproxalap, a novel reactive aldehyde species inhibitor, in a real-world model of allergen exposure.MethodsIn a randomized, double-masked, vehicle-controlled, crossover Phase 2 trial, 70 adult patients with ≥2 years of moderate to severe allergic conjunctivitis history, a positive skin test to ragweed pollen, and allergen chamber-induced ocular itching and redness scores of ≥2.5 and ≥2 (both scales range from 0 to 4), respectively, were randomized 1:1:1 to one of three sequences: 0.25% reproxalap, 0.5% reproxalap, and placebo; 0.5% reproxalap, placebo, and 0.25% reproxalap; or placebo, 0.25% reproxalap, and 0.5% reproxalap. Symptoms and conjunctival redness were assessed over 3.5 hours in an allergen chamber of aerosolized ragweed pollen (3500 grains/m3). Test article was administered bilaterally just before chamber entry and at 90 minutes after chamber entry.ResultsReproxalap was safe and well tolerated; 66 of 70 enrolled patients completed all visits. Relative to vehicle, both concentrations of reproxalap demonstrated statistically significant and clinically relevant improvements in ocular itching, tearing, and redness over the duration of exposure in the chamber (P < 0.001 for all assessments). Prophylactic and treatment activity of drug were demonstrated.ConclusionIn an allergen chamber, reproxalap, a novel reactive aldehyde species inhibitor, was statistically superior to vehicle across the typical symptoms and signs of allergic conjunctivitis. These data are among the first rigorous clinical results demonstrating drug improvement in allergic conjunctivitis in an allergen chamber, a real-world model of allergen exposure.
| S-EPMC8742616 | biostudies-literature
Project description:ObjectivesEar symptoms coincident with TMD symptoms have been noticed for a long time. The aim was to investigate the relationship between reported ear symptoms in TMD patients and different TMD symptoms, dental occlusion, oral parafunction and habits.Material and methodsConsecutive patients, ≥18 years of age and referred to a specialist clinic for orofacial pain and dysfunction during a three-month period, were considered for the study. Patients with poor general or psychiatric health were excluded. One hundred thirty-two patients were included and studied with regard to reported ear symptoms in relation to clinical dysfunction, occlusion, habits and subjective rating of their symptoms. A clinical examination was performed according to RDC/TMD and extended with occlusal factors, parafunctions and habits.ResultsEar symptoms were reported by 72% of the TMD patients, with ear fullness in 49% as the most frequent symptom. The patients with ear symptoms were significantly older and proportionally more often females. Ear symptoms were significantly correlated to the subjective index, to myalgia (p = 0.003), decreased opening capacity (p = 0.01), TMJ pain (p = 0.02), parafunctions (p = 0.007), and some occlusal factor (p = 0.018-0.003). Muscle pain on palpation was significantly associated with ear fullness, and changed hearing and sensitivity to sound, on the same side (p < 0.005).ConclusionsEar symptoms are frequently reported by TMD patients. Concomitant ear symptoms are associated with oral parafunction and muscle pain on palpation on the same side as the ear symptoms.
| S-EPMC8638311 | biostudies-literature
Project description:PurposeTo compare the safety and efficacy of intense pulsed light (IPL) followed by meibomian gland expression (MGX), against monotherapy of MGX.MethodsPatients with moderate to severe meibomian gland dysfunction (MGD) were 1:1 randomized to 4 sessions of intense pulse light + MGX at 2-week intervals, or 4 sessions of Sham + MGX at 2-week intervals. Both patients and examiners were blinded to the allocation. Outcome measures, evaluated at the baseline (BL) and at a follow-up (FU) conducted 4 weeks after the last IPL session, included fluorescein tear breakup time (TBUT) as the primary outcome measure, OSDI (Ocular Surface Disease Index) questionnaire, Eye Dryness Score (EDS, a visual analog scale (VAS)-based questionnaire), Meibomian gland score (MGS, a score of meibum expressibility and quality in 15 glands on the lower eyelid), daily use of artificial tears, and daily use of warm compresses. In addition, during each treatment session, the number of expressible glands was counted in both eyelids, the predominant quality of meibum was estimated in both eyelids, and the level of pain/discomfort due to MGX and IPL was recorded.ResultsTBUT increased from 3.8±0.2 (μ±standard error of mean (SEM)) to 4.5±0.3 seconds in the control arm, and from 4.0±0.2 to 6.0±0.3 in the study arm. The difference between arms was statistically significant (P < .01). Other signs/symptoms which improved in both arms but were greater in the study arm included MGS (P < .001), EDS (P < .01), the number of expressible glands in the lower eyelids (P < .0001) and upper eyelid (P < .0001), the predominant meibum quality in the lower eyelid (P < .0001) and upper eyelid (P < .0001), and the level of pain due to MGX (P < .0001). Outcome measures which improved in both arms with no significant differences between the two were OSDI (P = .9984), and the daily use of artificial tears (P = .8216). Meibography, daily use of warm compresses, and severity of skin rosacea did not show statistically significant changes in either arm. No serious adverse events were observed. There was a slight tendency for more adverse events in the control group (P = 0.06).ConclusionsThe results of this study suggest that, in patients with moderate to severe symptoms, combination therapy of intense pulse light (IPL) and meibomian gland expression (MGX) could be a safe and useful approach for improving signs of dry eye disease (DED) due to meibomian gland dysfunction (MGD). Future studies are needed to elucidate if and how such improvements can be generalized to different severity levels of MGD.
| S-EPMC9223330 | biostudies-literature
Project description:Objectives: The aim of this project was to develop an instructional video that demonstrates a standardized clinical examination on patients with suspected temporomandibular disorders (TMD). After viewing the video, the learner should be knowledgeable about the examination steps and application of the examination techniques. Methods: The instructional video was created by two dentists who are experienced in assessing patients with suspected TMD. Additionally, both examiners were calibrated according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). The instructional video was divided into chapters. Various camera angles, key points, image enlargements, and replays were used to better depict essential aspects of the assessment. Background noise was reduced to a minimum. Results: The instructional video was modified and completed in two phases: the first by an experienced dentist and the second by a dentist specialized in TMD. The final video includes nine chapters and is 26.5 minutes in length (https://doi.org/10.5061/dryad.k8r7qc1). Conclusion: Divided into chapters, this German instructional video shows an optimally timed, standardized clinical assessment of patients with suspected TMD.
| S-EPMC7346288 | biostudies-literature
Project description:Central neuropathic pain (CNP) is a significant problem after spinal cord injury (SCI). Pharmacological and non-pharmacological approaches may reduce the severity, but relief is rarely substantial. While deep brain stimulation (DBS) has been used to treat various chronic pain types, the technique has rarely been used to attenuate CNP after SCI. Here we present the case of a 54-year-old female with incomplete paraplegia who had severe CNP in the lower limbs and buttock areas since her injury 30 years prior. She was treated with bilateral DBS of the midbrain periaqueductal gray (PAG). The effects of this stimulation on CNP characteristics, severity and pain-related sensory function were evaluated using the International SCI Pain Basic Data Set (ISCIPBDS), Neuropathic Pain Symptom Inventory (NPSI), Multidimensional Pain Inventory and Quantitative Sensory Testing before and periodically after initiation of DBS. After starting DBS treatment, weekly CNP severity ratings rapidly decreased from severe to minimal, paralleled by a substantial reduction in size of the painful area, reduced pain impact and reversal of pain-related neurological abnormalities, i.e., dynamic-mechanical and cold allodynia. She discontinued pain medication on study week 24. The improvement has been consistent. The present study expands on previous findings by providing in-depth assessments of symptoms and signs associated with CNP. The results of this study suggest that activation of endogenous pain inhibitory systems linked to the PAG can eliminate CNP in some people with SCI. More research is needed to better-select appropriate candidates for this type of therapy. We discuss the implications of these findings for understanding the brainstem's control of chronic pain and for future progress in using analgesic DBS in the central gray.
| S-EPMC5382156 | biostudies-literature
Project description:PurposeTo evaluate the efficacy of multi-frequency RF and IPL + MGX combination for treatment of Meibomian Gland Dysfunction (MGD).Patients and methodsEligible subjects had signs and moderate-to-severe symptoms of DED (Dry Eye Disease) due to MGD. Subjects underwent 4 treatments at 2-week intervals. Each treatment consisted of intense pulsed light (IPL) followed by radiofrequency (RF) on the periocular skin, followed by meibomian gland expression (MGX). The main outcome measure was the quality of meibum in 15 meibomian glands along the lower eyelid, using the modified Meibomian Gland Score (mMGS). The main hypothesis was a reduction of mMGS between the baseline (BL) and the follow-up (FU). Other outcome measures, such as symptoms measured with the OSDI (Ocular Surface Disease Index) questionnaire, meibography, non-invasive tear break-up time (NIBUT), and matrix metallopeptidase 9 (MMP-9) levels in tear samples were evaluated as well.Results31 subjects completed the FU. Between BL and FU, mMGS decreased from 30.4 (8.5) to 9.3 (9.5) (-69.3%, 95% CI: -55.6% to -82.9%, p<0.0001); OSDI decreased from 63.6 (17.2) to 25.0 (20.6) (-60.7%, 95% CI: -47.8% to -73.5%, p<0.0001); NIBUT did not change (p=0.92). An adjusted model with a historical control was constructed to allow the comparison of these subjects with those treated similarly with IPL+MGX (but without RF) in a different study. This analysis identified that the change in mMGS was larger when RF was included (-20.9 vs -18.3, adjusted p-value (p_adjusted) <0.05). The difference in OSDI change was not significant (-38.1 vs -25.5, p_adjusted = 0.196).ConclusionCombination of multi-frequency RF and IPL+MGX improves signs and symptoms of MGD. In comparison to a historical control, improvements were generally larger. A randomized controlled study comparing the combination of RF and IPL+MGX with IPL+MGX alone is required to further elaborate the relative contribution of RF.
| S-EPMC10595163 | biostudies-literature