The effect of physical exercise during radiotherapy on physical performance in patients with head and neck cancer: a trial within cohorts study protocol, the vital study.

BACKGROUND: During the last decade, twelve studies have been published investigating physical exercise interventions (PEIs) in patients with head and neck cancer (HNC) during radiotherapy (RT), chemoradiation (CRT) or bioradiation (BRT). These studies showed that these PEIs are safe and feasible. However, only two of these studies were randomised clinical trials (RCTs) with a satisfying sample size. Thereby, there is no cost-effectiveness study related to a PEI during RT, CRT or BRT ((C/B)RT) for patients with HNC. Therefore, the aim of this study is to investigate and compare physical performance, muscle strength, fatigue, quality of life (QoL), body mass index (BMI), nutritional status, physical activity, treatment tolerability, and health care related costs in patients with HNC with and without a 10 week PEI during (C/B)RT. METHODS: This study, based on a trial within cohorts (TwiCs) design, will contain a prospective cohort of at least 112 patients. Fifty-six patients will randomly be invited for an experimental 10 week PEI. This PEI consists of both resistance and endurance exercises to optimize physical performance, muscle strength, fatigue, QoL, BMI, nutritional status, physical activity, and treatment tolerability of (C/B)RT. Measurements are at baseline, after 12 weeks, 6 months, and at 12 months. Statistical analyses will be performed for intention-to-treat and instrumental variable analysis. DISCUSSION: This study seeks to investigate physical, QoL, and economic implications of a PEI. With a substantial sample size, this study attempts to strengthen and expand knowledge in HNC care upon PEI during (C/B)RT. In conclusion, this study is dedicated to provide additional evidence for PEI in patients with HNC during (C/B)RT. TRIAL REGISTRATION: protocol was registered at clinicaltrials.gov with number NCT05988060 on 3 August 2023.

Long-Term Clinical Results of Percutaneous Cervical Nucleoplasty for Cervical Radicular Pain: A Retrospective Cohort Study.

Purpose: Percutaneous cervical nucleoplasty (PCN) is a minimally invasive treatment for cervical radicular pain due to a disc herniation. Preliminary results show equivalent patient-reported outcomes of PCN as compared to conventional anterior cervical discectomy. However, there is a paucity of long-term outcome data. Therefore, the primary objective of this study is to investigate the long-term clinical results of PCN. Patients and Methods: A retrospective analysis was conducted on patients who underwent PCN at a secondary referral center between 2010 and 2014. Before surgery and five days after surgery, numeric rating scales (NRS) for arm pain and neck pain and data on complications were collected. To determine long-term follow-up outcomes, patients were sent a questionnaire booklet containing the Core Outcome Measures Index-Neck (COMI-Neck), NRS for arm pain and neck pain, Likert-scales on patient satisfaction and questions regarding the incidence of reoperations and complications. Results: The baseline characteristics were collected for 158 patients. At a median follow-up of 41.5 months (interquartile range (IQR) 27.0 to 57.5), data were available for 118 patients (74.7%). At short-term follow-up, patients that underwent PCN had a mean decrease of 3.0 on the NRS for arm pain (95% CI 2.5 to 3.6) compared to baseline, while at long-term follow-up, a mean decrease of 2.8 (95% CI 1.0 to 3.6) was observed. At the long-term follow-up, 67.8% of the patients were fully recovered from all symptoms and 93.3% remained satisfied with the PCN treatment results. The reoperation rate for recurrent disc herniation was 21.4% at long-term follow-up. Conclusion: PCN appears to be a safe and effective treatment at short-term and long-term follow-up of a specific selection of cervical herniated discs, with an acceptable long-term reoperation rate. These study results suggest a potential role of PCN as a less invasive treatment option for cervical radicular pain due to a soft disc herniation, before anterior cervical discectomy should be considered.

Development of an automated tool to score the Headache Screening Questionnaire: Agreement between automated and manual scoring.

BACKGROUND: Migraines and tension-type headaches (TTH) are primary headaches that can be screened with the Headache Screening Questionnaire (HSQ). However, the HSQ scoring algorithms rely on manual calculation, which is laborious and carries a risk of human error. OBJECTIVE: To develop an automated tool to calculate the output of the HSQ scoring algorithm and to determine the agreement between the automated and manual calculation. DESIGN: A cross-sectional design was used. METHODS: The automated tool was developed as a Microsoft Excel spreadsheet that was tested with all possible answers for the HSQ. An experienced researcher had access to answers to the HSQ from 163 people with headaches and manually applied the migraine and TTH algorithms to obtain the final scores and classifications. After that, the same answers were uploaded into the spreadsheet and scored by the automated algorithm. The agreement between manual and automated scoring was calculated for the total score using Intraclass Correlation Coefficients (ICC2,1), Standard Error of Measurement (SEM), and Limits of Agreement. The agreement between the classification obtained by the automated tool and the classification obtained by manual calculation for migraine and TTH was calculated using weighted Kappas (k-values). RESULTS: The total score showed excellent agreement for migraine (ICC = 0.97, 95% CI = 0.96-0.98, SEM = 0.36) and good agreement for TTH (ICC = 0.87, 95% CI = 0.82-0.90, SEM = 0.55). The classification demonstrated excellent agreement for migraine (k-value = 0.93, 95% CI = 0.89-0.97) and for TTH (k-value = 0.78, 95% CI = 0.70-0.86). CONCLUSION: Implementation of the automated tool in clinical practice is suggested when using the HSQ to screen patients with primary headaches.