Efficacy of photobiomodulation therapy combined with mobile health education in patients with head and neck cancer suffering from chronic xerostomia after radiotherapy: protocol for a three-arm, randomised, placebo-controlled, double-blinded study.

INTRODUCTION: The role of photobiomodulation (PBM) therapy for oral tissue damage induced by cancer treatment is currently unclear, and there is low-quality to moderate-quality evidence supporting the use of this approach for treating xerostomia and/or hyposalivation. Consequently, patients with head and neck cancer increasingly turn to basic oral hygiene to alleviate salivary gland dysfunction, and their adherence can be improved by mobile health (mHealth) education. The primary objective of this study will be to analyse the effects of different doses of PBM therapy (7.5 J/cm2 vs 3 J/cm2) plus mHealth education on quality of life (QoL), oral health, salivary secretion and salivary gland ultrasound assessment at postintervention and at the 6-month follow-up in patients with head and neck cancer after radiotherapy compared with those in control group. METHODS AND ANALYSIS: A prospective, three-arm, randomised, placebo-controlled, double-blinded study will be conducted among patients with head and neck cancer suffering from chronic xerostomia. A total of 20 patients per arm will be included and randomly assigned to receive 7.5 J/cm2 of PBM, 3 J/cm2 of PBM or placebo therapy. PBM therapy will be applied during 24 sessions at 22 points extra and intraorally two times per week for 3 months, combined with a mobile application (https://www.laxer.es). The assessments will be recorded at the beginning of the study, at postintervention and at the 6-month follow-up. The primary outcomes will be QoL, oral health, salivary secretion and salivary gland ultrasound. The pain pressure threshold, functional performance, mood and sleep quality will be secondary indicators. ETHICS AND DISSEMINATION: This study received ethics approval from the Andalusian Biomedical Research Ethics Portal (2402-N-21 CEIM/CEI Provincial de Granada) according to the Declaration of Helsinki for Biomedical Research. The results of this study will be presented at national and international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT05106608.

Acute and cumulative benefits of Photobiomodulation for xerostomia: A systematic review and meta-analysis.

The objective was to explore the effectiveness of photobiomodulation therapy for treating patients who suffer xerostomia and/or hyposalivation due to the most prevalent clinical diagnoses. We searched PubMed, Scopus, Web of Science, CINAHL and Cochrane Library for randomized or clinical controlled trials published until 31 October 2019. Risk of bias assessment and meta-analysis were conducted using the Cochrane tools. A total of 274 records were retrieved, and 11 met the inclusion criteria. Interventions whose parameters ranged between wavelengths of 790-830 nm (infrared), 30-120 mW of power and an energy density below 30 J/cm-2 were associated with improvements in xerostomia/hyposalivation. As for the assessment of methodological quality, 10 of the 11 articles included had a high risk of overall bias. Only 3 articles provided sufficient information to conduct a meta-analysis for quality of life, compared with placebo in patients with burning mouth syndrome, showing a standardized mean difference between groups from baseline of -0.90 (-1.48; -0.32). The present review and meta-analysis suggest that photobiomodulation therapy is an effective, non-invasive and safe approach in patients with xerostomia. However, despite the potential, it is not possible to reach a reliable consensus on the parameters to be used, and future studies should be conducted by standardizing intervention protocols.

Effects of a Single Myofascial Induction Session on Neural Mechanosensitivity in Breast Cancer Survivors: A Secondary Analysis of a Crossover Study.

OBJECTIVES: The purpose of this study was to investigate the short-term effects of myofascial induction on mechanosensitivity of upper limb nerves. METHODS: In this secondary analysis of a randomized, single-blind, placebo-controlled crossover study, 21 breast cancer survivors with stage I-IIIA cancer were randomly allocated to an experimental group (30 minutes of myofascial induction session) or placebo control group (unplugged pulsed 30 minutes of shortwave therapy), with a 4-week washout period between sessions that occurred in a physical therapy laboratory in the Health Science Faculty (University of Granada, Spain). Range of motion (universal goniometry), structural differentiation, symptoms (yes/no), and pressure pain thresholds (electronic algometry) were assessed during neurodynamic tests and attitude toward massage scale as covariate. RESULTS: An analysis of covariance revealed significant time × group interactions for range of motion in affected upper limb nerves (median, P < .001; radial, P = .036; ulnar, P = .002), but not for nonaffected upper limb nerves (median, P = .083; radial, P = .072; ulnar, P = .796). A χ2 or Fisher exact test, as appropriate, also revealed a significant difference (P = .044) in sensitivity for the affected upper limb ulnar nerve in the experimental group, whereas the rest of the assessed nerves (affected and nonaffected upper limb nerves) showed no significant changes in either the experimental or control groups (P > .05). An analysis of covariance revealed no significant interactions on pressure pain thresholds over the nerves for affected (all P > .05) and nonaffected (all P > .05) upper limb nerves. CONCLUSION: A single myofascial induction session may partially improve mechanosensitivity of median, radial, and ulnar nerves and yield positive effects on symptom mechanosensitivity, especially regarding the ulnar nerve in breast cancer survivors.

Myofascial Induction Effects on Neck-Shoulder Pain in Breast Cancer Survivors: Randomized, Single-Blind, Placebo-Controlled Crossover Design.

OBJECTIVES: To (1) investigate the immediate effects of myofascial induction (MI), with placebo electrotherapy as a control, on perceived pain, cervical/shoulder range of motion (ROM), and mood state in breast cancer survivors (BCSs) with shoulder/arm morbidity; and (2) examine the relationships between pain modifications and cervical/shoulder ROM on the side affected by breast cancer. DESIGN: Randomized, single-blind, placebo-controlled crossover study. SETTING: Physical therapy laboratory. PARTICIPANTS: BCSs (N=21) who had a diagnosis of stage I-IIIA breast cancer and had completed adjuvant therapy (except hormonal treatment). INTERVENTION: During each session, the BCSs received either an MI (fascial unwinding) intervention focused on the upper limb area following the Pilat approach or placebo pulsed shortwave therapy (control group). Each session lasted 30 minutes, and an adequate washout period of 4 weeks between sessions was established. MAIN OUTCOME MEASURES: The visual analog scale (VAS) for pain and anxiety, shoulder-cervical goniometry for ROM, the Profile of Mood States for psychological distress, and the Attitudes Towards Massage Scale were used. RESULTS: An analysis of covariance (ANCOVA) revealed significant time × group interactions for VAS affected arm (P=.031) but not for VAS cervical (P=.332), VAS nonaffected arm (P=.698), or VAS anxiety (P=.266). The ANCOVA also revealed significant interactions for affected shoulder flexion (P<.001), abduction (P<.001), external rotation (P=.004), and internal rotation (P=.001). Significant interactions for affected cervical rotation (P=.022) and affected cervical lateral flexion (P=.038) were also found. A significant negative correlation was found between changes in VAS affected arm and shoulder/arm internal rotation ROM (r=-.46; P=.03). CONCLUSIONS: A single MI session decreases pain intensity and improves neck-shoulder ROM to a greater degree than placebo electrotherapy for BCSs experiencing pain.

Do Patient Profiles Influence the Effects of Massage? A Controlled Clinical Trial.

Considerable scientific evidence has been published on the effectiveness of massage in different conditions, but it remains unclear whether this effectiveness is modulated by the profile of patients. The aim of this study was to compare the effects of a 21-min myofascial therapy protocol on stress responders and nonresponders stressed in the laboratory with a cold pressor test. Dependent variables included heart rate variability (HRV), blood pressure, and salivary markers such as flow rate, cortisol, immunoglobulin A (IgA), and α-amylase activity. A controlled, repeated measures, single-blind trial was conducted in 30 Caucasian students with a mean (SD) age of 20.70 (4.50) years. We found no significant between-group differences in descriptive characteristics or in any preintervention outcome measure. Analysis of covariance revealed significant increases in HRV index (F = 0.18, p = .01), salivary flow rate (F = 0.16, p = .02), and salivary IgA concentration (F = 4.36, p = .04) and significant decreases in the low-frequency domain (F = 0.18, p = .04) and LF-high-frequency ratio (F = 0.18, p = .01) in the stress responder group in comparison to the nonresponder group. In conclusion, a better response to massage was observed in stress responders than in nonresponders across various HRV parameters and salivary measures.

Immunological effects of massage after exercise: A systematic review.

OBJECTIVE: The objective of this review was to determine whether immune parameters can be modulated by massage after intense physical activity. METHODS: A search was conducted in Pub Med Medline, PEDro, and Cochrane databases, using the key words: "massage", "myofascial release", "acupressure", "recovery", and "warm up" combined with "exercise", "exercise-induced muscle damage", "sport", "immunology", and lymphocytes" independently. Only controlled studies published between 1970 and 2012 were selected, with no restrictions regarding publication language. The CONSORT Declaration was applied to assess the quality of the selected studies. RESULTS: The initial search identified 739 publications in the databases, of which only 5 met the review inclusion criteria. A positive relationship between immunological recovery and post-exercise massage was reported by some of these studies but not by others. CONCLUSION: There is preliminary evidence that massage may modulate immune parameters when applied after exercise, but more research is needed to confirm this possibility.

Evaluation of e-learning as an adjunctive method for the acquisition of skills in bony landmark palpation and muscular ultrasound examination in the lumbopelvic region: a controlled study.

OBJECTIVE: The purpose of this study was to determine whether the acquisition of competence in palpation and ultrasound imaging in the lumbopelvic region can be improved by the use of e-learning strategies. METHODS: This study was a single-blind randomized controlled study. Forty-four physical therapy undergraduate students (29 females) from the University of Granada (Spain) received an educational module of on-campus training in palpation and ultrasound examination of the lumbopelvic area. The participants were randomly distributed into 2 groups: the e-learning group, with free access to a Web site on musculoskeletal palpation and ultrasound assessment, and the control group, with access to documents and books on the topic. Objective structured clinical evaluation and reproducibility between professorial staff and students in multifidus cross-sectional area ultrasound imaging were used to assess the educational intervention. RESULTS: Objective structured clinical evaluation scores were statistically significantly higher in the e-learning group than in the control group for skills in palpation ability and ultrasound assessment of the lumbopelvic area (both P < .001). CONCLUSION: This study suggests that e-learning may be an adjunct educational strategy to acquire musculoskeletal manual skills and ultrasound imaging of the lumbopelvic area.