Dataset Information

Photobiomodulation therapy on the palliative care of temporomandibular disorder and orofacial/cervical skull pain: study protocol for a randomized controlled clinical trial.

ABSTRACT:

Background

Temporomandibular disorder (TMD) is the most common cause of orofacial and cervical skull pain and is considered to be a public health problem, affecting 5% to 12% of the world population. TMD is multifactorial and there are several types of treatment, with the conservative types being indicated more often as they are less aggressive and reversible. The main aim of these treatments is to relieve symptoms, reduce of pain, and restore orofacial and cervical skull functions. Photobiomodulation therapy (PBMT), a noninvasive therapy, is an option for the management of musculoskeletal disorders due to its analgesic, anti-inflammatory, and regenerative effects.

Methods

The aim of the proposed study is to verify whether PBMT is effective for use in palliative care of TMD and orofacial and cervical skull pain. A randomized, triple-blinded, placebo-controlled clinical trial is proposed. This study will involve 200 adult participants (over 18?years of age) who will be randomly divided into two groups (n?=?100): Group 1, active treatment (PBMT); and Group 2, placebo. Participants will be subjected to three sessions of PBMT or placebo and will be evaluated using the research diagnostic criteria (RDC) for TMD. Pain level (measured by a visual analog scale (VAS)), mandibular movements (measured by ruler and caliper), quality of life (measured by the Oral Health Impact Profile (OHIP)-14), and quality of sleep (measured by the Epworth scale) will be recorded. This study is being conducted at the Special Laboratory of Lasers in Dentistry (LELO) of the School of Dentistry of the University of Sao Paulo (USP).

Discussion

This study will verify whether PBMT is effective in reducing TMD and orofacial and cervical skull pain. PBMT may be an option for the management of musculoskeletal disorders due to its analgesic, anti-inflammatory, and regenerative effects, in addition to being a noninvasive technique.

Trial registration

Registro Brasileiro de Ensaios Clínicos, RBR-9b6mnj . Registered on 27 March 2018. Trial registry name: Laser de baixa potência no cuidado paliativo da disfunção temporomandibular e dor crânio orofacial e cervical. Ethics committee: #1774930 approved on 14 October 2016.

SUBMITTER: Carvalho FR

PROVIDER: S-EPMC6451204 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Publications

Photobiomodulation therapy on the palliative care of temporomandibular disorder and orofacial/cervical skull pain: study protocol for a randomized controlled clinical trial.

Carvalho Fernando Rodrigues FR Barros Rafael Queiroz RQ Gonçalves Alyne Simões AS Freitas Patrícia Moreira PM

Trials 20190406 1

<h4>Background</h4>Temporomandibular disorder (TMD) is the most common cause of orofacial and cervical skull pain and is considered to be a public health problem, affecting 5% to 12% of the world population. TMD is multifactorial and there are several types of treatment, with the conservative types being indicated more often as they are less aggressive and reversible. The main aim of these treatments is to relieve symptoms, reduce of pain, and restore orofacial and cervical skull functions. Phot ...[more]

PMID: 30954086

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Project description:Fibromyalgia (FM) is a syndrome most prevalent in women, in whom it is characterized mainly by chronic pain. An important issue is that many patients with FM are reported to have temporomandibular dysfunction (TMD), and the coexistence of these pathologies generates a clinical outcome of high complexity. The literature is unclear regarding an effective therapy for reducing pain in patients with both comorbidities. Exercise training and phototherapy (low-level laser therapy with light-emitting diode) are two of the approaches used to treat pain. Thus, the aim of this study is to assess the potential role of exercise training plus phototherapy in reducing chronic pain in women with FM and TMD. A further aim is to determine whether the interventions can improve quality of life and modulate endogenous serotonin.A randomized controlled clinical trial will be conducted. It will involve 60 women ? 35 years of age with a diagnosis of FM and TMD. After recruitment, patients will be randomly allocated to one of four groups: a control group (no intervention), a group that will receive a phototherapy intervention (PHO), a group that will be prescribed muscle-stretching, aerobic, and facial exercises (EXT), or a group that will receive phototherapy plus exercise interventions (PHO + EXT). The trial will last 10 weeks, and the following outcomes will be evaluated on two separate occasions (baseline and within 24 h after the last day of the protocol). Pain intensity will be analyzed using a visual analogue scale and the McGill Pain Questionnaire, and pain thresholds will be punctuated using a digital algometer. FM symptoms will be assessed using the Fibromyalgia Impact Questionnaire, and quality of life will be determined with the 36-item Short Form Health Survey. Serotonin levels will be evaluated in salivary samples using a competitive enzyme-linked immunosorbent assay.This is the first randomized controlled trial in which the role of phototherapy, exercise training, and a combination of these interventions will be evaluated for chronic pain in patients with FM and TMD. The results will offer valuable clinical evidence for objective assessment of the potential benefits and risks of procedures.ClinicalTrials.gov Identifier: NCT02279225. Registered 27 October 2014.

Project description:This study evaluates contributions of jaw injury and experimental pain sensitivity to risk of developing painful temporomandibular disorder (TMD). Data were from the Orofacial Pain: Prospective Evaluation and Risk Assessment (OPPERA) nested case-control study of incident painful TMD. Injury and subsequent onset of painful TMD were monitored prospectively for ≤5 y in a community-based sample of 409 US adults who did not have TMD when enrolled. At baseline, thermal-pressure and pinprick pain sensitivity, as potential effect modifiers, were measured using quantitative sensory testing. During follow-up, jaw injury from any of 9 types of potentially traumatic events was determined using quarterly (3-monthly) health update questionnaires. Study examiners classified incident painful TMD, yielding 233 incident cases and 176 matched controls. Logistic regression models, estimated incidence odds ratios (IORs), and 95% confidence limits (CLs) were used for the association between injury and subsequent onset of painful TMD. During follow-up, 38.2% of incident cases and 13.1% of controls reported 1 or more injuries that were 4 times as likely to be intrinsic (i.e., sustained mouth opening or yawning) as extrinsic (e.g., dental visits, whiplash). Injuries due to extrinsic events (IOR = 7.6; 95% CL, 1.6-36.2), sustained opening (IOR = 5.4; 95% CL, 2.4-12.2), and yawning (IOR = 3.4; 95% CL, 1.6-7.3) were associated with increased TMD incidence. Both a single injury (IOR = 6.0; 95% CL, 2.9-12.4) and multiple injuries (IOR = 9.4; 95% CL, 3.4,25.6) predicted greater incidence of painful TMD than events perceived as noninjurious (IOR = 1.9; 95% CL, 1.1-3.4). Injury-associated risk of painful TMD was elevated in people with high sensitivity to heat pain (IOR = 7.4; 95% CL, 3.1-18.0) compared to people with low sensitivity to heat pain (IOR = 3.9; 95% CL, 1.7-8.4). Jaw injury was strongly associated with elevated painful TMD risk, and the risk was amplified in subjects who had enhanced sensitivity to heat pain at enrollment. Commonly occurring but seemingly innocuous events, such as yawning injury, should not be overlooked when judging prognostic importance of jaw injury.

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Project description:The specific palliative care needs and problems of patients with a substance use disorder and multiple problems, and those of their proxies, are under recognized Besides, the organization of palliative care, including the division of health care professionals' responsibilities, is often unclear. Perspectives of patients and proxies are hardly known. We describe the outline of a study designed to explore how palliative care for patients with a substance use disorder is organized in the Netherlands and to explore problems and needs, as well as possible improvements from the healthcare professionals', patients' and proxies' perspective. The aim of this protocol paper is to provide insights in ways to conduct research with vulnerable research participants and to offer a detailed description of the study design. The broader study aims to gain insight in and formulate recommendations on how to improve palliative care for patients with a substance use disorder.A qualitative study with patients, proxies and healthcare professionals. Semi-structured interviews will be held with 10-15 patients who suffer from a severe substance use disorder. They are in a palliative care trajectory and either diagnosed with a chronic or life-threatening disease or, as a result of addictive behavior, a physical deterioration without the prospect of cure. Semi-structured interviews will also be held with 5-10 proxies. Healthcare professionals, volunteers and/or 'experts-by-experience' (n?=?24-40) will be participating in semi-structured group interviews. All (group) interviews will be thematically analyzed. Additionally, a strengths, weaknesses, opportunities and threats (SWOT) analysis will be applied to the group interview data with the aim to summarize and concretize the findings.Everyone has a right to an optimal end-of-life phase of life and a dignified dying process. This study will provide valuable knowledge about palliative care for patients with a substance use disorder and explicitly bring to light the needs and problems of the patients and their proxies and healthcare professionals in a palliative care phase.

Project description:Background:Patients with chronic orofacial pain due to temporomandibular disorders (TMD) display alterations in somatosensory processing at the jaw, such as amplified perception of tactile stimuli, but the underlying mechanisms remain unclear. This study investigated one possible explanation, namely hypervigilance, and tested if TMD patients with unilateral pain showed increased attending to somatosensory input at the painful side of the jaw. Methods:TMD patients with chronic unilateral orofacial pain (n = 20) and matched healthy volunteers (n = 20) performed a temporal order judgment (TOJ) task indicated which one of two tactile stimuli, presented on each side of the jaw, they had perceived first. TOJ methodology allows examining spatial bias in somatosensory processing speed. Furthermore, after each block of trials, the participants rated the perceived intensity of tactile stimuli separately for both sides of the jaw. Finally, questionnaires assessing pain catastrophizing, fear-avoidance beliefs, and pain vigilance, were completed. Results:TMD patients tended to perceive tactile stimuli at the painful jaw side as occurring earlier in time than stimuli at the non-painful side but this effect did not reach conventional levels of significance (p = .07). In the control group, tactile stimuli were perceived as occurring simultaneously. Secondary analyses indicated that the magnitude of spatial bias in the TMD group is positively associated with the extent of fear-avoidance beliefs. Overall, intensity ratings of tactile stimuli were significantly higher in the TMD group than in the control group, but there was no significant difference between the painful and non-painful jaw side in the TMD patients. Discussion:The hypothesis that TMD patients with chronic unilateral orofacial pain preferentially attend to somatosensory information at the painful side of the jaw was not statistically supported, although lack of power could not be ruled out as a reason for this. The findings are discussed within recent theories of pain-related attention.

Project description:BackgroundPain due to temporomandibular disorders (TMDs) often has the same clinical symptoms and signs as other types of orofacial pain (OP). The possible presence of serious neurological and/or systemic organic pathologies makes differential diagnosis difficult, especially in early disease stages. In the present study, we performed a qualitative and quantitative electrophysiological evaluation of the neuromuscular responses of the trigeminal nervous system. Using the jaw jerk reflex (JJ) and the motor evoked potentials of the trigeminal roots ((b)R-MEPs) tests, we investigated the functional and organic responses of healthy subjects (control group) and patients with TMD symptoms (TMD group).MethodThirty-three patients with temporomandibular disorder (TMD) symptoms and 36 control subjects underwent two electromyographic (EMG) tests: the jaw jerk reflex test and the motor evoked potentials of the trigeminal roots test using bilateral electrical transcranial stimulation. The mean, standard deviation, median, minimum, and maximum values were computed for the EMG absolute values. The ratio between the EMG values obtained on each side was always computed with the reference side as the numerator. For the TMD group, this side was identified as the painful side (pain side), while for the control group this was taken as the non-preferred masticatory side (non-preferred side). The 5th, 10th, 25th, 50th, 75th, 90th, and 95th percentiles were also calculated.ResultsAnalysis of the ratios (expressed as percentages) between the values obtained on both sides revealed a high degree of symmetry in the (b)R-MEPs % in the control (0.93 +/- 0.12%) and TMD (0.91 +/- 0.22%) groups. This symmetry indicated organic integrity of the trigeminal root motor fibers and correct electrode arrangement. A degree of asymmetry of the jaw jerk's amplitude between sides (ipJJ%), when the mandible was kept in the intercuspal position, was found in the TMD group (0.24% +/- 0.14%) with a statistically significant difference in relation to the control group (0.61% +/- 0.2%). This asymmetry seemed to be primarily due to a failure to facilitate the reflex on the painful side in intercuspal position.ConclusionsIn this 2 x 2 matrix diagnostic model, three different types of headache may be identified: 1) those due to organic pathologies directly and indirectly involving the trigeminal nervous system denoted as "Organic Damage"; 2) those in TMD patients; 3) other types of orofacial pain in subjects who could erroneously be considered healthy, denoted as Orofacial Pain "OP". This category of patient should be considered at risk, as organic neurological pathologies could be present and yet not directly affect the trigeminal system, at least in the early stages of the disease.

Dataset Information

Photobiomodulation therapy on the palliative care of temporomandibular disorder and orofacial/cervical skull pain: study protocol for a randomized controlled clinical trial.

Background

Methods

Discussion

Trial registration

Publications

Photobiomodulation therapy on the palliative care of temporomandibular disorder and orofacial/cervical skull pain: study protocol for a randomized controlled clinical trial.

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