Patient Experience of Photobiomodulation Therapy in Head and Neck Chronic Lymphedema.

Purpose: Lymphedema is a common late effect of head and neck cancer treatment that causes various symptoms, functional impairment, and poor quality of life. We completed a pilot, prospective, single-arm clinical trial to determine the feasibility and potential efficacy of the use of photobiomodulation (PBM) therapy for head and neck lymphedema. In this study, we report patients' perceived treatment experience of PBM therapy and provide suggestions to better understand head and neck cancer survivors' experience of PBM therapy. Methods: Head and neck cancer patients who underwent PBM therapy completed face-to-face semi-structured interviews. Interviews were audio-recorded and then transcribed verbatim. Qualitative content analysis was used to analyze the transcriptions from the interviews. Results: Among 12 participants who consented for the study, 11 (91.7%) completed the PBM therapy. Participants described positive experiences and unique benefits about the PBM therapy, for example, decreased swelling, reduced tightness, increased range of motion, increased saliva production, and improved ability to swallow. Some participants (n = 5, 45.5%) delineated challenges related to traffic, travel time, and distance from study location. Many participants proposed suggestions for future research on PBM therapy, for example, research on internal edema and its relationship with swallowing, and indicated patients with severe lymphedema and fibrosis may be more likely to benefit. Conclusions: Findings from this study suggested the potential benefits of PBM therapy in treatment of chronic head and neck lymphedema. Rigorously designed clinical trials are needed to evaluate the effect of PBM therapy for head and neck cancer-related lymphedema. Trial Registration Number and Date of Registration: ClinicalTrials.gov Identifier: NCT03738332; date of registration: November 13, 2018.

Conducting a supportive oncology clinical trial during the COVID-19 pandemic: challenges and strategies.

The coronavirus disease 2019 (COVID-19) pandemic resulted in severe interruptions to clinical research worldwide. This global public health crisis required investigators and researchers to rapidly develop and implement new strategies and solutions to mitigate its negative impact on the progress of clinical trials. In this paper, we describe the challenges, strategies, and lessons learned regarding the continuation of a supportive oncology clinical trial during the pandemic. We hope to provide insight into the implementation of clinical trials during a public health emergency to be better prepared for future instances.Trial registration: ClinicalTrials.gov, a service of the US National Institute of Health (NCT03030859). Registered on 22 January 2017.

Photobiomodulation Therapy in Head and Neck Cancer-Related Lymphedema: A Pilot Feasibility Study.

PURPOSE: Lymphedema is a common debilitating late effect among patients post-head and neck cancer (HNC) treatment. Head and neck lymphedema was associated with symptom burden, functional impairment, and decreased quality of life. The objective of this study was to determine the feasibility and potential efficacy of the use of photobiomodulation (PBM) therapy for head and neck lymphedema, symptom burden, and neck range of motion among HNC survivors. METHODS: This was a single-arm, pre- and post-design clinical trial. Eligible patients included those with lymphedema after completion of complete decongestive therapy (CDT) and 3 to 18 months after completion of cancer therapy. The intervention included PBM therapy 2 times a week for 6 weeks for a total of 12 treatments. Lymphedema, symptom burden, and neck range of motion were measured at baseline, end-of-intervention, and 4-week post-intervention. RESULTS: Of the 12 patients enrolled in the study, 91.7% (n = 11) completed the study intervention and assessment visits, and no adverse events were reported. When comparing the baseline to 4-week post-intervention, we found statistically significant improvements in the severity of external lymphedema, symptom burden, and neck range of motion (all P < .05). CONCLUSION: PBM therapy was feasible and potentially effective for the treatment of head and neck lymphedema. Future randomized controlled trials are warranted to examine the efficacy of PBM therapy for HNC-related lymphedema. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: ClinicalTrials.gov Identifier: NCT03738332; date of registration: November 13, 2018.

Effect of Home-Based Exercise and Weight Loss Programs on Breast Cancer-Related Lymphedema Outcomes Among Overweight Breast Cancer Survivors: The WISER Survivor Randomized Clinical Trial.

IMPORTANCE: To our knowledge, no randomized clinical trials have assessed the effects of the combination of weight loss and home-based exercise programs on lymphedema outcomes. OBJECTIVE: To assess weight loss, home-based exercise, and the combination of weight loss and home-based exercise with clinical lymphedema outcomes among overweight breast cancer survivors. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial (Women in Steady Exercise Research [WISER] Survivor clinical trial ) of 351 overweight breast cancer survivors with breast cancer-related lymphedema (BCRL) was conducted in conference rooms at academic and community hospitals and in the homes of participants from March 12, 2012, to May 28, 2016; follow-up was conducted for 1 year from the start of the intervention. Statistical analysis by intention to treat was performed from September 26, 2018, to October 28, 2018. INTERVENTIONS: A 52-week, home-based exercise program of strength/resistance training twice per week and 180 minutes of walking per week, a weight loss program of 20 weeks of meal replacements and 52 weeks of lifestyle modification counseling, and a combination of the home-based exercise and weight loss programs. MAIN OUTCOMES AND MEASURES: The 12-month change in the percentage of interlimb volume difference. RESULTS: Of 351 participants, 90 were randomized to the control group (facility-based lymphedema care with no home-based exercise or weight loss intervention), 87 to the exercise intervention group, 87 to the weight loss intervention group, and 87 to the combined exercise and weight loss intervention group; 218 (62.1%) were white, 122 (34.8%) were black, and 11 (3.1%) were of other races or ethnicities. Median time since breast cancer diagnosis was 6 years (range, 1-29 years). Mean (SD) total upper extremity score changes from the objective clinical evaluation were -1.40 (11.10) in the control group, -2.54 (13.20) in the exercise group, -3.54 (12.88) in the weight loss group, and -3.84 (10.09) in the combined group. Mean (SD) overall upper extremity score changes from the self-report survey were -0.39 (2.33) in the control group, -0.12 (2.14) in the exercise group, -0.57 (2.47) in the weight loss group, and -0.62 (2.38) in the combined group. Weight loss from baseline was -0.55% (95% CI, -2.22% to 1.11%) in the control group, -8.06% (95% CI, -9.82% to 6.29%) in the combined group, -7.37% (95% CI, -8.90% to -5.84%) in the weight loss group, and -0.44% (95% CI, -1.81% to 0.93%) in the exercise group. CONCLUSIONS AND RELEVANCE: Study results indicate that weight loss, home-based exercise, and combined interventions did not improve BCRL outcomes; a supervised facility-based program of exercise may be more beneficial than a home-based program for improving lymphedema outcomes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01515124.

Intra- and Interrater Reliability and Concurrent Validity of a New Tool for Assessment of Breast Cancer-Related Lymphedema of the Upper Extremity.

OBJECTIVE: The goal of this study was to develop and assess intra- and interrater reliability and validity of a clinical evaluation tool for breast cancer-related lymphedema, for use in the context of outcome evaluation in clinical trials. DESIGN: Blinded repeated measures observational study. SETTING: Outpatient research laboratory. PARTICIPANTS: Breast cancer survivors with and without lymphedema (N=71). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: The assessment of intraclass correlation coefficients (ICCs) for the Breast Cancer-Related Lymphedema of the Upper Extremity (CLUE) standardized clinical evaluation tool. RESULTS: Intrarater reliability for the CLUE tool was ICC: 0.88 (95% confidence interval [95% CI], 0.71-0.96). Interrater reliability for the CLUE tool was ICC: 0.90 (95% CI, 0.79-0.95). Concurrent validity of the CLUE score (Pearson r) was 0.79 with perometric interlimb difference and 0.53 with the Norman lymphedema overall score. CONCLUSIONS: The CLUE tool shows excellent inter- and intrarater reliability. The overall CLUE score for the upper extremity also shows moderately strong concurrent validity with objective and subjective measures. This newly developed clinical, physical assessment of upper extremity lymphedema provides standardization and a single score that accounts for multiple constructs. Next steps include evaluation of sensitivity to change, which would establish usefulness to evaluate intervention efficacy.

Using kinematics and a dynamical systems approach to enhance understanding of clinically observed aberrant movement patterns.

The objective of this technical paper is to demonstrate how graphing kinematic data to represent body segment coordination and control can assist clinicians and researchers in understanding typical and aberrant human movement patterns. Aberrant movements are believed to be associated with musculoskeletal pain and dysfunction. A dynamical systems approach to analysing movement provides a useful way to study movement control and coordination. Continuous motion angle-angle and coupling angle-movement cycle graphs provide information about coordinated movement between body segments, whereas phase-plane graphs provide information about neuromuscular control of a body segment. Examples demonstrate how a dynamical systems approach can be used to represent (1) typical movement patterns of the lumbopelvic and shoulder regions; (2) aberrant coordination in an individual with low back pain who presented with altered lumbopelvic rhythm; and (3) aberrant control of shoulder movement in an individual with observed scapular dysrhythmia. Angle-angle and coupling angle-movement cycle graphs were consistent with clinical operational definitions of typical and altered lumbopelvic rhythm. Phase-plane graphs illustrated differences in scapular control between individuals having typical scapular motion and an individual with scapular dysrhythmia. Angle-angle, coupling angle-movement cycle, and phase-plane graphs provide information about the amount and timing of segmental motion, which clinicians assess when they observe movements. These approaches have the potential to (1) enhance understanding of typical and aberrant movement patterns; (2) assist with identifying underlying movement impairments that contribute to aberrant movements: and (3) improve clinicians' ability to visually assess and categorize functional movements.

Prediction of in-season shoulder injury from preseason testing in division I collegiate football players.

BACKGROUND: Collegiate football is a high-demand sport in which shoulder injuries are common. Research has described the incidence of these injuries, with little focus on causative factors or injury prevention. HYPOTHESIS: Football athletes who score lower on preseason strength and functional testing are more likely to sustain an in-season shoulder injury. STUDY DESIGN: Prospective, cohort study. LEVEL OF EVIDENCE: Level 2. METHODS: Twenty-six collegiate football players underwent preseason testing with a rotational profile for shoulder range of motion, isometric strength of the rotator cuff at 90° elevation and external rotation in the 90/90 position, fatigue testing (prone-Y, scaption, and standing cable press), and the Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST). Data collected postseason included the type of shoulder injury and the side injured. Logistic regression was used to determine if the testing measures predicted injury, and a receiver operating characteristic curve was constructed to examine the relationship of CKCUEST to injury. RESULTS: Six athletes sustained shoulder injuries during the season. Predictor variables could significantly predict whether that player would sustain an injury during the season for both the right and left shoulders (P < 0.05). The variables that were significantly correlated with injury of the right side were forward elevation strength, prone-Y to fatigue, and the CKCUEST (P < 0.05); on the left, only the CKCUEST was significant (P < 0.05). The area under the receiver operating characteristic curve for the CKCUEST was 0.86 (ϵ = 0.87, P = 0.01). Using a score of 21 touches, the CKCUEST had a sensitivity of 0.83, a specificity of 0.79, and an odds ratio of 18.75 in determining whether a player sustained a shoulder injury. CONCLUSION: For this sample, the combination of preseason strength, fatigue, and functional testing was able to identify football players who would sustain a shoulder injury during the season. CLINICAL RELEVANCE: Using a battery of strength, fatigue, and functional testing may be helpful in identifying football players during preseason who are at a higher risk for sustaining a shoulder injury. This information can be used to optimize preseason testing and implementation of injury prevention programs.

Shoulder impairments and their association with symptomatic rotator cuff disease in breast cancer survivors.

Over 2.6 million breast cancer survivors currently reside in the United States. While improvements in the medical management of women diagnosed with breast cancer have resulted in a 5-year survival rate of 89%, curative treatments are associated with a high prevalence of shoulder and arm morbidity, which, in turn, can negatively impact a woman's quality of life. Breast cancer survivors frequently experience shoulder and arm pain, decreased range of motion, muscle weakness, and lymphedema. These symptoms can lead to difficulties with daily activities ranging from overhead reaching and carrying objects to caring for family and returning to work. Despite health care professionals awareness of these problems, a significant number of breast cancer survivors are confronted with long-term, restricted use of their affected shoulder and upper extremity. This problem may partially be explained by: (1) an incomplete understanding of relevant impairments and diagnoses associated with shoulder/arm pain and limited upper extremity use, and (2) the limited effectiveness of current rehabilitation interventions for managing shoulder pain and decreased upper extremity function in breast cancer survivors. Because breast cancer treatment directly involves the neuromusculoskeletal tissues of the shoulder girdle, it is understandable why breast cancer survivors are likely to develop shoulder girdle muscle weakness and fatigue, decreased shoulder motion, altered shoulder girdle alignment, and lymphedema. These impairments can be associated with diagnoses such as post-mastectomy syndrome, adhesive capsulitis, myofascial dysfunction, and brachial plexopathy, all of which have been reported among breast cancer survivors. It is our belief that these impairments also put women at risk for developing symptomatic rotator cuff disease. In this paper we set forth the rationale for our belief that breast cancer treatments and subsequent impairments of shoulder girdle neuromusculoskeletal tissues place breast cancer survivors at risk for developing symptomatic rotator cuff disease. Additionally, we identify knowledge gaps related to the current understanding of relevant shoulder girdle impairments and their association with symptomatic rotator cuff disease in breast cancer survivors. Ultimately, information from studies designed to meet these gaps will provide a scientific basis for the development of new, or refinement of existing, examination, intervention, and prevention techniques, which should lead to improved clinical outcomes in this population.

Scapulothoracic motion and muscle activity during the raising and lowering phases of an overhead reaching task.

Scapulothoracic muscle activity is essential for normal scapulothoracic motion. While previous research has furthered the understanding of scapulothoracic motion and muscle activity during the raising phase of motion, a gap exists with respect to the lowering phase. The purpose of this study was to compare scapulothoracic motion and scapulothoracic muscle activity between the raising and lowering phases of an overhead reaching task. Twenty healthy subjects volunteered to participate in the study. Three-dimensional scapulothoracic motion was collected using an electromagnetic device. Surface electromyography (EMG) was used to assess muscle activity from the upper trapezius, lower trapezius, and serratus anterior muscles. Overall scapulothoracic motion was similar for the raising and lowering phases of the overhead reaching task. However, significantly lower EMG amplitude values existed during the lowering phase across all muscles. Less muscle activity during the lowering phase may reflect differing neuromuscular control strategies between arm raising and lowering. These findings suggest that scapulothoracic muscle activation levels during eccentric contractions may be closer to an activation threshold below which their ability to control scapulothoracic motion may be compromised subsequently leading to altered scapulothoracic motion (scapular dyskinesis). This provides a possible explanation for why scapular dyskinesis is more notable during the lowering phase of motion.