PaiNEd app. Assessing central sensitization in survivors of breast cancer: A reliability study.

Introduction: Pain is a common adverse event in survivors of breast cancer (sBCs). As there is no gold standard to assess pain experience predominantly related to central sensitization (CS) symptoms, we designed the PaiNEd app, which includes an algorithm to report whether patients are under predominant CS pain mechanisms. Objective: We aimed to assess the reliability of the PaiNEd app to estimate whether sBC pain experience is predominantly related to CS symptoms. Methods: An observational, descriptive reliability design was employed to assess the inter- and intrarater reliability of the PaiNEd app. This app includes an algorithm that considers the number of painful body parts and some questionnaires related to pain, such as the Numeric Pain-Rating Scale, the Brief Pain Inventory, the Tampa Scale for Kinesiophobia, the Pain Catastrophizing Scale, and the Central Sensitization Inventory (CSI). Results: A total of 21 sBCs with persistent pain were recruited. We observe a general trend of close agreement between the paper-based and app-based formats (ICCs ranged between 0.802 and 0.972; Cronbach's alpha ranged between 0.797 and 0.971). Test-retest reliabilities were moderate to excellent (ICCs ranged between 0.510 and 0.941; Cronbach's alpha ranged between 0.499 and 0.938). The agreement between the categorization of the CS algorithm and the CSI (cut-off point ≥ 40 for CS symptoms) was 95.24%. Conclusion: The PaiNEd app emerges as a robust tool for evaluating pain experience predominantly related to CS and pain-related symptoms in sBCs. Its demonstrated reliability not only bolsters its utility but also signifies its potential as a valuable asset for healthcare professionals engaged in pain education programs.

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.

Persistent pain management in an oncology population through pain neuroscience education, a multimodal program: PaiNEd randomized clinical trial protocol.

INTRODUCTION: Pain is one of the most persistent symptoms after cancer treatment. The central nervous system can erroneously stay in its alarm phase, altering the pain experience of patients who have cancer. Pain neuroscience education (PNE) with multimodal approaches may benefit these patients. OBJECTIVE: This protocol aims to determine the effectiveness of a PNE tool on pain, physical function and quality of life, as a supplement to a multimodal rehabilitation (MR) program in patients who had breast cancer (BC). METHODS: An 8-week double-blinded randomized controlled trial will be conducted, including 72 participants who had BC and who have persistent pain, randomized into three groups: PNE program + MR program, traditional biomedical information + MR program and control group. The PNE program will include educational content that participants will learn through a mobile app and the MR program will include a concurrent exercise program and manual therapy. The primary outcome will be the perceived pain assessed using the Visual Analogue Scale and secondary outcomes are others related to pain, physical function and quality of life. All outcomes will be evaluated at baseline, at the end of the intervention and 6 months after the end of intervention. DISCUSSION: The proposed study may help BC patients with persistent pain improve their pain experience, quality of life and provide for more adaptive pain-coping strategies. This protocol could propose an action guide to implement different integral approaches for the treatment of sequelae. This treatment option could be offered to this patient profile and it could be easily implemented in the healthcare systems due to its low costs. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04877860. (February18, 2022).

Upper body motor function and swallowing impairments and its association in survivors of head and neck cancer: A cross-sectional study.

BACKGROUND: Upper body motor function and swallowing may be affected after curative treatment for head and neck cancer. The aims of this study are to compare maximum mouth opening (MMO), temporomandibular dysfunction (TMD), cervical and shoulder active range of motion (AROM) and strength, and swallowing difficulty between survivors of head and neck cancer (sHNC) and healthy matched controls (HMC) and to examine the correlations between these outcomes in sHNC. METHODS: Thirty-two sHNC and 32 HMC participated on the study. MMO, TMD, cervical and shoulder AROM, cervical and shoulder strength, the SPADI shoulder pain and disability indices, the Eating Assessment Tool (EAT-10) score, swallowing difficulty as determined using a visual analogue scale (VAS), and the location of disturbances in swallowing, were recorded. RESULTS: MMO and cervical and shoulder AROM and strength were significantly lower in sHNC, whereas FAI, SPADI score, EAT-10 and VAS were higher. The MMO, TMD, cervical and shoulder AROM, and cervical shoulder strength values showed significant correlations (some direct, others inverse) with one another. Swallowing difficulty was inversely associated with the MMO, cervical AROM and shoulder strength. CONCLUSION: Compared with controls, sHNC present smaller MMO, lower cervical and shoulder AROM, lower cervical and shoulder strength and higher perception of TMD, shoulder pain and disability and swallowing difficulty. sHNC suffer impaired swallowing related to lower MMO, presence of TMD, cervical AROM and shoulder strength values. Improving these variables via physiotherapy may reduce the difficulty in swallowing experienced by some sHNC.

Salvage radiosurgery for selected patients with recurrent malignant gliomas.

PURPOSE: To analyse the survival after salvage radiosurgery and to identify prognostic factors. METHODS: We retrospectively reviewed 87 consecutive patients, with recurrent high-grade glioma, that underwent stereotactic radiosurgery between 1997 and 2010. We evaluated the survival after initial diagnosis and after reirradiation. The prognostic factors were analysed by bivariate and multivariate Cox regression model. RESULTS: The median age was 48 years old. The primary histology included anaplastic astrocytoma (47%) and glioblastoma (53%). A margin dose of 18 Gy was administered in the majority of cases (74%). The median survival after initial diagnosis was 21 months (39 months for anaplastic astrocytoma and 18.5 months for glioblastoma) and after reirradiation it was 10 months (17 months for anaplastic astrocytoma and 7.5 months for glioblastoma). In the bivariate analyses, the prognostic factors significantly associated with survival after reirradiation were age, tumour and treatment volume at recurrence, recursive partitioning analyses classification, Karnofsky performance score, histology, and margin to the planning target volume. Only the last four showed significant association in the multivariate analyses. CONCLUSION: stereotactic radiosurgery is a safe and may be an effective treatment option for selected patients diagnosed with recurrent high-grade glioma. The identified prognostic factors could help individualise the treatment.

Selective use of postoperative neck radiotherapy in oral cavity and oropharynx cancer: a prospective clinical study.

BACKGROUND: In cervical postoperative radiotherapy, the target volume is usually the same as the extension of the previous dissection. We evaluated a protocol of selective irradiation according to the risk estimated for each dissected lymph node level. METHODS: Eighty patients with oral/oropharyngeal cancer were included in this prospective clinical study between 2005 and 2008. Patients underwent surgery of the primary tumor and cervical dissection, with identification of positive nodal levels, followed by selective postoperative radiotherapy. Three types of selective nodal clinical target volume (CTV) were defined: CTV0, CTV1, and CTV2, with a subclinical disease risk of <10%, 10-25%, and 25% and a prescribed radiation dose of <35 Gy, 50 Gy, and 66-70 Gy, respectively. The localization of node failure was categorized as field, marginal, or outside the irradiated field. RESULTS: A consistent pattern of cervical infiltration was observed in 97% of positive dissections. Lymph node failure occurred within a high-risk irradiated area (CTV1-CTV2) in 12 patients, marginal area (CTV1/CTVO) in 1 patient, and non-irradiated low-risk area (CTV0) in 2 patients. The volume of selective lymph node irradiation was below the standard radiation volume in 33 patients (mean of 118.6 cc per patient). This decrease in irradiated volume was associated with greater treatment compliance and reduced secondary toxicity. The three-year actuarial nodal control rate was 80%. CONCLUSION: This selective postoperative neck irradiation protocol was associated with a similar failure pattern to that observed after standard neck irradiation and achieved a significant reduction in target volume and secondary toxicity.