Reply to Bourgeois, P. Comment on "Devoogdt et al. The Effectiveness of Fluoroscopy-Guided Manual Lymph Drainage as Part of Decongestive Lymphatic Therapy on the Superficial Lymphatic Architecture in Patients with Breast Cancer-Related Lymphoedema: A Randomised Controlled Trial. Cancers 2023, 15, 1545".

We appreciate the commentary by Pierre Bourgeois [...].

Reliability, concurrent validity, and clinical feasibility of measurement methods determining volume in patients with lower limb lymphedema and healthy controls.

PURPOSE: To investigate reliability, concurrent validity, and clinical feasibility of measurements assessing volume in patients with lower limb lymphedema (LLL) and healthy controls. MATERIALS AND METHODS: To investigate intra- and interrater reliability, 47 patients with LLL and 30 healthy controls were assessed three times by two assessors. To investigate between session reliability, 50 participants were reassessed two weeks later. Each assessment included measurements of the midline region (hip circumference; suprapubic volume), leg volume (perimeter every 4 cm; Perometer®), and foot volume (water displacement; figure-of-eight method). Concurrent validity was assessed with correlation coefficients. Measurements were timed and practical limitations were reviewed. Clinical trial registration number: NCT: 05269264. RESULTS: Measurements of the total volume of different regions showed weak to very high intraclass correlation coefficients (ICCs) (0.131-998). Absolute and relative volume differences had lower ICC values (0.360-0.976). A strong correlation was found between the total volumes of the same region. The Perometer® and figure-of-eight method were the fastest method for leg and foot volume, respectively. CONCLUSIONS: The assessed total volumes might be more valuable in assessing the evolution of volume in bilateral LLL than the calculated absolute and relative differences between both limbs. The Perometer® and figure-of-eight method were the most time efficient for leg and foot volume, respectively.Implications for rehabilitationLymphedema is a chronic condition for which a reliable and clinically feasible assessment of volume is essential for the diagnosis, treatment decisions, and the evaluation of the treatment.This study shows that the total leg/foot volumes were more reliable than the calculated absolute and relative differences between both limbs and could therefore more valuable to evaluate bilateral lower limb lymphedema.For the assessment of leg volume, the Perometer® was the most reliable and fastest method.For the evaluation of the foot volume, the figure-of-eight method was overall the best method.

Accuracy of consumer-based activity trackers to measure and coach patients with lower limb lymphoedema.

PURPOSE: This study investigated the accuracy of activity trackers in chronic lower limb lymphoedema (LLL) patients and in comparison to matched controls. MATERIALS AND METHODS: Seventeen LLL patients and 35 healthy subjects wore an activity tracker at the hip (Fitbit Zip/Inspire; hip-AT) and one at the wrist (Fitbit Alta/Inspire; wrist-AT) combined with a reference activity monitor (Dynaport Movemonitor; DAM), for 14 consecutive days. To analyze accuracy and agreement, mean daily step count from both AT's were compared to DAM. To evaluate the accuracy as coaching tool, day-by-day differences were calculated. The Kendall correlation coefficient was used to test consistency of ranking daily steps between the AT's and the DAM. RESULTS: The wrist-AT significantly overestimated daily step count compared to DAM in the LLL group (+1221 ± 1754 steps per day, p = 0.011) while the hip-AT underestimated the step count, although not significantly. Similar results were found in the healthy control group. As a coaching tool, both wrist-AT and hip-AT showed a moderate correlation with the DAM (r = 0.507 and 0.622, respectively) in the LLL group regarding consistency of ranking from most to least active days. CONCLUSION: Wrist-AT's significantly overestimate daily step count in a LLL population. As a coaching tool, both trackers show moderate validity, indicating applicability to improve physical activity.

Upper-Limb Movement Quality before and after Surgery in Women with Breast Cancer: An Exploratory Study.

(1) Background: This study aimed to describe upper-limb (UL) movement quality parameters in women after breast cancer surgery and to explore their clinical relevance in relation to post-surgical pain and disability. (2) Methods: UL movement quality was assessed in 30 women before and 3 weeks after surgery for breast cancer. Via accelerometer data captured from a sensor located at the distal end of the forearm on the operated side, various movement quality parameters (local dynamic stability, movement predictability, movement smoothness, movement symmetry, and movement variability) were investigated while women performed a cyclic, weighted reaching task. At both test moments, the Quick Disabilities of the Arm, Shoulder, and Hand (Quick DASH) questionnaire was filled out to assess UL disability and pain severity. (3) Results: No significant differences in movement quality parameters were found between the pre-surgical and post-surgical time points. No significant correlations between post-operative UL disability or pain severity and movement quality were found. (4) Conclusions: From this study sample, no apparent clinically relevant movement quality parameters could be derived for a cyclic, weighted reaching task. This suggests that the search for an easy-to-use, quantitative analysis tool for UL qualitative functioning to be used in research and clinical practice should continue.

Potential therapeutic effect of a ketogenic diet for the treatment of lymphoedema: Results of an exploratory study.

BACKGROUND: Lymphoedema is a chronic and progressive disease characterised by excessive accumulation of lymph in the interstitial compartment, leading to tissue swelling and fibroadipose deposition. Lymphangiogenesis is partly regulated by ketone body oxidation, and a ketogenic diet (KD) has shown therapeutic efficacy in a preclinical mouse tail lymphoedema model. Therefore, we aimed to investigate the potential therapeutic effect of a KD in patients with secondary lymphoedema. METHODS: Nine patients with unilateral stage 2 lymphoedema secondary to lymphadenectomy were included in this quasi-experimental exploratory study consisting of a short run-in phase to gradually induce ketosis, followed by a classic KD (CKD) and modified Atkins diet (MAD) phase during which patients consumed a CKD and MAD, respectively. Lymphatic function and oedema volume, the primary outcomes, were assessed at baseline and at the end of both the CKD and MAD phase. Secondary outcomes included health-related and lymphedema-specific quality of life (QoL). RESULTS: Seven out of nine patients completed the study protocol. Lymphatic function was improved upon consumption of both a CKD (dermal backflow score [mean ± SD]: 7.29 ± 2.98 vs. 10.86 ± 2.19 at baseline; p = 0.03) and MAD (6.71 ± 2.06; p = 0.02), whereas oedema volume did not decrease during the course of the study (excess limb volume [mean ± SD]: 20.13 ± 10.25% at end of CKD and 24.07 ± 17.77% at end of MAD vs. 20.79 ± 12.96% at baseline; p > 0.99 and p > 0.30, respectively). No changes were observed in health-related, nor lymphoedema-specific QoL at the end of CKD and MAD. CONCLUSIONS: The consumption of a KD improved lymphatic function and was associated with a clinically meaningful reduction in oedema volume in some patients (3/7 at end of CKD, 2/7 at end of MAD) with unilateral stage 2 secondary lymphoedema. These results highlight the potential of a KD to improve lymphatic function in patients with lymphoedema. However, further studies are required to substantiate our findings.

SurLym trial: study protocol for a multicentre pragmatic randomised controlled trial on the added value of reconstructive lymphatic surgery to decongestive lymphatic therapy for the treatment of lymphoedema.

INTRODUCTION: Lymphoedema is a chronic condition caused by lymphatic insufficiency. It leads to swelling of the limb/midline region and an increased risk of infection. Lymphoedema is often associated with mental and physical problems limiting quality of life. The first choice of treatment is a conservative treatment, consisting of exercises, skin care, lymph drainage and compression. Reconstructive lymphatic surgery is also often performed, that is, lymphovenous anastomoses, lymph node transfer or a combination. However, robust evidence on the effectiveness of reconstructive lymphatic surgery is missing. Therefore, the objective of this trial is to investigate the added value of reconstructive lymphatic surgery to the conservative treatment in patients with lymphoedema. METHODS AND ANALYSIS: A multicentre randomised controlled and pragmatic trial was started in March 2022 in three Belgian university hospitals. 90 patients with arm lymphoedema and 90 patients with leg lymphoedema will be included. All patients are randomised between conservative treatment alone (control group) or conservative treatment with reconstructive lymphatic surgery (intervention group). Assessments are performed at baseline and at 1, 3, 6, 12, 18, 24 and 36 months. The primary outcome is lymphoedema-specific quality of life at 18 months. Key secondary outcomes are limb volume and duration of wearing the compression garment at 18 months. The approach of reconstructive lymphatic surgery is based on presurgical investigations including clinical examination, lymphofluoroscopy, lymphoscintigraphy, lymph MRI or CT angiography (if needed). All patients receive conservative treatment during 36 months, which is applied by the patient's own physical therapist and by the patient self. From months 7 to 12, the hours a day of wearing the compression garment are gradually decreased. ETHICS AND DISSEMINATION: The study has been approved by the ethical committees of University Hospitals Leuven, Ghent University Hospital and CHU UCL Namur. Results will be disseminated via peer-reviewed journals and presentations. TRIAL REGISTRATION NUMBER: NCT05064176.

Prognostic factors for the development of upper limb dysfunctions after breast cancer: the UPLIFT-BC prospective longitudinal cohort study protocol.

INTRODUCTION: Upper limb (UL) dysfunctions are highly prevalent in people after breast cancer and have a great impact on performing activities in daily living. To improve care, a more comprehensive understanding of the development and persistence of UL dysfunctions is needed. Therefore, the UPLIFT-BC study will primarily examine the prognostic value of different factors at the body functions and structures, environmental and personal level of the International Classification of Functioning, Disability and Health (ICF) framework at 1-month post-surgery for persisting UL dysfunctions at 6 months after finishing cancer treatment. METHODS AND ANALYSIS: A prospective longitudinal cohort study, running from 1-week pre-surgery to 6 months post-local cancer treatment, is performed in a cohort of 250 women diagnosed with primary breast cancer. Different potentially prognostic factors to UL dysfunctions, covering body functions and structures, environmental and personal factors of the ICF, are assessed pre-surgically and at different time points post-surgery. The primary aim is to investigate the prognostic value of these factors at 1-month post-surgery for subjective UL function (ie, QuickDASH) at 6 months post-cancer treatment, that is, 6 months post-radiotherapy or post-surgery (T3), depending on the individuals' cancer treatment trajectory. In this, factors with relevant prognostic value pre-surgery are considered as well. Similar analyses are performed with an objective measure for UL function (ie, accelerometry) and a composite score of the combination of subjective and objective UL function. Second, in the subgroup of participants who receive radiotherapy, the prognostic value of the same factors is explored at 1-month post-radiotherapy and 6 months post-surgery. A forward stepwise selection strategy is used to obtain these multivariable prognostic models. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of UZ/KU Leuven (reference number s66248). The results of this study will be published in peer-reviewed journals and will be presented at several research conferences. TRIAL REGISTRATION NUMBER: NCT05297591.

Continuum of somatosensory profiles in breast cancer survivors with and without pain, compared to healthy controls and patients with fibromyalgia.

CONTEXT: The prevalence of persistent pain among breast cancer survivors (BCS) is high, and it is unclear what distinguishes those with persistent pain from those without. Research suggests that differences in somatosensory function evaluated by quantitative sensory testing (QST) may be responsible. OBJECTIVES: This study aimed to describe somatosensory profiles in terms of hyper- and hypoesthesia in BCS with and without persistent pain using reference data from healthy controls. Second, QST parameters of BCS with and without pain were compared with those of healthy controls (i.e., a negative control group) and patients with fibromyalgia (i.e., a positive control group). METHODS: Participants (n = 128) were divided into four equal groups: healthy controls, BCS with persistent pain, BCS without persistent pain, and patients with fibromyalgia. Nine QST parameters were evaluated at the trunk and at a remote location. Somatosensory profiles were determined by Z-score transformation of QST data using normative data from healthy controls. RESULTS: At the trunk, compared to healthy controls, BCS with persistent pain exhibited sensory aberrations across five out of seven QST parameters: pressure pain threshold, mechanical detection, and thermal thresholds. Pain-free BCS showed similar sensory aberrations across the four QST parameters compared to healthy controls: mechanical detection and thermal thresholds. Temporal summation and conditioned pain modulation were not significantly different between groups. CONCLUSION: BCS with persistent pain exert aberrations in peripheral processing of nociceptive signals, heightened facilitation of nociceptive signals, and higher psychosocial burden when compared to pain-free BCS, healthy controls, and patients with fibromyalgia. SIGNIFICANCE: This study investigates the somatosensory function of breast cancer survivors with and without persistent pain using quantitative sensory testing and two control group (i.e., patients with fibromyalgia and healthy controls). Our results indicate somatosensory aberrations within the peripheral, but not central pathways in breast cancer survivors with persistent pain. Our findings contribute to a better understanding of the somatosensory mechanisms underlying persistent pain, which may inform future interventions to prevent the development of persistent pain, and improve treatment modalities.

Concurrent validity of dynamic bedside quantitative sensory testing paradigms in breast cancer survivors with persistent pain.

BACKGROUND: Studies on the concurrent validity of clinically applicable testing protocols for conditioned pain modulation (CPM) and temporal summation of pain (TSP) in breast cancer survivors (BCS) with persistent pain are lacking. OBJECTIVES: This study investigated the concurrent validity of two bedside protocols for CPM and TSP in comparison to a respective reference protocol. The participants' preferences for bedside CPM and TSP protocols were assessed. METHODS: Thirty BCS experiencing persistent pain were included in this study. Each participant underwent a reference test along with two bedside alternatives for assessing both TSP and CPM. For CPM, a cold pressor test (CPT) and blood pressure cuff (BPC) were used as conditioning stimulus. The test stimulus was elicited in parallel by pressure pain threshold after 45 and 90 s of conditioning at the lower limb. The CPM reference test consisted of parallel heat stimuli at the forearms using a two-thermode system. TSP was elicited using a von Frey monofilament (256 mN) and an algometer (98 kPa) at the affected site and opposite lower limb. The TSP reference test consisted of heat stimuli at the affected site and opposite lower limb. Participants' testing preference was examined using a purpose-designed questionnaire. Spearman's rank test examined the correlation between protocols. RESULTS: The two bedside CPM protocols were strongly correlated (r = 0.787-0.939, p < 0.005). A strong correlation was found between the BPC protocol and reference test using the relative effect magnitude (r = 0.541-0.555, p < 0.005). The bedside TSP protocols were moderately correlated with each other only at the lower limb using absolute change scores (r = 0.455, p = 0.012). No significant correlation was found between the bedside and reference TSP protocols. CONCLUSION: The significantly moderate to very strong correlations between the bedside protocols validate their interchangeability. Researchers and clinicians should be able to choose which bedside protocol they utilize; however, participants favored the use of a BPC and algometer for the evaluation of CPM and TSP, respectively.

Effectiveness of pain neuroscience education on somatosensory functioning after surgery for breast cancer: A double-blinded randomized controlled trial.

Pain is one of the most prevalent and long-term adverse effects described by people who have undergone breast cancer surgery. Non-helpful perceptions and thoughts about pain may contribute to the transition of acute to persistent pain. Adding educational interventions to the current physical therapy program in this population may help to improve or prevent persistent pain. Pain neuroscience education (PNE) is a type of educational intervention that addresses the experience of pain in a broader sense by explaining pain not only from a biomedical perspective, but also from a psychological and social perspective. A double-blinded randomized controlled trial (EduCan trial) investigated whether PNE, in addition to a standard physiotherapy program immediately after surgery for breast cancer, was more effective on somatosensory functioning in the short (4 months postoperatively) and long term (18 months postoperatively), than providing a biomedical explanation for pain. Somatosensory functioning was evaluated using a self-reported questionnaire as well as a comprehensive quantitative sensory testing evaluation. The findings of this study revealed that adding six sessions of PNE to a standard physical therapy program (n = 184) did not result in a significantly different course of somatosensory functioning up to 18 months postoperatively as compared to biomedical pain education. These findings provide an interesting basis for future research into who should receive PNE after surgery for breast cancer (e.g., patient profiling or phenotyping) and how we can tailor it to the individual to increase its effectiveness.

The VASCERN PPL working group patient pathway for primary and paediatric lymphoedema.

Lymphoedema is caused by an imbalance between fluid production and transport by the lymphatic system. This imbalance can be either caused by reduced transport capacity of the lymphatic system or too much fluid production and leads to swelling associated with tissue changes (skin thickening, fat deposition). Its main common complication is the increased risk of developing cellulitis/erysipelas in the affected area, which can worsen the lymphatic function and can be the cause of raised morbidity of the patient if not treated correctly/urgently. The term primary lymphoedema covers a group of rare conditions caused by abnormal functioning and/or development of the lymphatic system. It covers a highly heterogeneous group of conditions. An accurate diagnosis of primary lymphoedema is crucial for the implementation of an optimal treatment plan and management, as well as to reduce the risk of worsening. Patient care is diverse across Europe, and national specialised centres and networks are not available everywhere. The European Reference Network on Rare Multisystemic Vascular Diseases (VASCERN) gathers the best expertise in Europe and provide accessible cross-border healthcare to patients with rare vascular diseases. There are six different working groups in VASCERN, which focus on arterial diseases, hereditary haemorrhagic telangiectasia, neurovascular diseases, lymphoedema and vascular anomalies. The working group Paediatric and Primary Lymphedema (PPL WG) gathers and shares knowledge and expertise in the diagnosis and management of adults and children with primary and paediatric lymphoedema. The members of PPL WG have worked together to produce this opinion statement reflecting strategies on how to approach patients with primary and paediatric lymphoedema. The objective of this patient pathway is to improve patient care by reducing the time to diagnosis, define the best management and follow-up strategies and avoid overuse of resources. Therefore, the patient pathway describes the clinical evaluation and investigations that lead to a clinical diagnosis, the genetic testing, differential diagnosis, the management and treatment options and the patient follow up at expert and local centres. Also, the importance of the patient group participation in the PPL WG is discussed.

Accuracy of consumer-based activity trackers as measuring tool and coaching device in breast and colorectal cancer survivors.

PURPOSE: Consumer-based activity trackers are used to measure and promote PA. We studied the accuracy of a wrist- and waist-worn activity tracker in cancer survivors and compared these results to a healthy age-matched control group. METHODS: Twenty-two cancer survivors and 35 healthy subjects wore an activity tracker at the waist and at the wrist combined with a reference activity monitor at the waist (Dynaport Movemonitor). The devices were worn for 14 consecutive days. The mean daily step count from both activity trackers was compared with the reference activity monitor to investigate accuracy and agreement (paired t-test, intraclass correlation, Bland-Altman plots). To evaluate the accuracy as a coaching tool, day-by-day differences within patients were calculated. The Kendall correlation coefficient was used to test the consistency of ranking daily steps between the activity trackers and the reference activity monitor. RESULTS: The wrist-worn wearable significantly overestimated the daily step count in the cancer group (mean ± SDΔ: + 1305 (2685) steps per day; p = 0.033) and in the healthy control group (mean ± SDΔ: + 1598 (2927) steps per day; p = 0.003). The waist-worn wearable underestimated the step count in both groups, although this was not statistically significant. As a coaching device, moderate (r = 0.642-0.670) and strong (r = 0.733-0.738) accuracy was found for the wrist- and waist-worn tracker, respectively, for detecting day-by-day variability in both populations. CONCLUSION: Our results show that wrist-worn activity trackers significantly overestimate daily step count in both cancer survivors and healthy control subjects. Based on the accuracy, in particular, the waist-worn activity tracker could possibly be used as a coaching tool.

Assessing Upper Limb Function in Breast Cancer Survivors Using Wearable Sensors and Machine Learning in a Free-Living Environment.

(1) Background: Being able to objectively assess upper limb (UL) dysfunction in breast cancer survivors (BCS) is an emerging issue. This study aims to determine the accuracy of a pre-trained lab-based machine learning model (MLM) to distinguish functional from non-functional arm movements in a home situation in BCS. (2) Methods: Participants performed four daily life activities while wearing two wrist accelerometers and being video recorded. To define UL functioning, video data were annotated and accelerometer data were analyzed using a counts threshold method and an MLM. Prediction accuracy, recall, sensitivity, f1-score, 'total minutes functional activity' and 'percentage functionally active' were considered. (3) Results: Despite a good MLM accuracy (0.77-0.90), recall, and specificity, the f1-score was poor. An overestimation of the 'total minutes functional activity' and 'percentage functionally active' was found by the MLM. Between the video-annotated data and the functional activity determined by the MLM, the mean differences were 0.14% and 0.10% for the left and right side, respectively. For the video-annotated data versus the counts threshold method, the mean differences were 0.27% and 0.24%, respectively. (4) Conclusions: An MLM is a better alternative than the counts threshold method for distinguishing functional from non-functional arm movements. However, the abovementioned wrist accelerometer-based assessment methods overestimate UL functional activity.

Returning to Work After Breast Cancer Surgery: A Randomised Controlled Trial on the Effect of Pain Neuroscience Education.

PURPOSE: The aim of this study was to investigate the effect of pain neuroscience education compared to biomedical pain education after breast cancer surgery on (1) work status, (2) time until work resumption, and (3) change in return-to-work expectations up to 18 months post-surgery. METHODS: Participants were randomly assigned to either pain neuroscience education (intervention group) or biomedical pain education (control group) in addition to a standard physical therapy program after surgery for breast cancer. The first four months following surgery, one to two physiotherapy sessions and three educational sessions were scheduled. After, two educational sessions and two physiotherapy sessions were held at six and eight months postoperatively. All outcomes were assessed at four, six, eight, 12 and 18 months postoperatively. RESULTS: At 12 months, in the intervention group, 71% of the women returned to work compared to 53% in the control group (18% points difference, 95%CI:-0.1 to 35;p = 0.07). At 18 months, the differences decreased to 9% points, 95%CI:-26 to 7;p = 0.35). Neither time until work resumption (p = 0.46) nor change in estimation of own ability to return to work up to 18 months postoperatively (p = 0.21) significantly differed between both groups. CONCLUSION: No significant differences were found regarding return to work outcomes between women receiving pain neuroscience education versus biomedical pain education after breast cancer surgery. Further research is warranted to explore the potential role of pain neuroscience education in return-to-work interventions following breast cancer surgery.

Comparison of the effectiveness of eHealth self-management interventions for pain between oncological and musculoskeletal populations: a systematic review with narrative synthesis.

OBJECTIVES: The aim of this systematic review is to compare the effectiveness of eHealth self-management interventions on pain intensity between oncological and musculoskeletal populations and to examine barriers and facilitators of the use of eHealth self-management tools. CONTENT: In March 2021, a systematic search of the literature was conducted using the databases PubMed and Web of Science. Studies that investigated the effect of eHealth self-management interventions on pain intensity in an oncological and/or a musculoskeletal population were included. SUMMARY: No study was found with a direct comparison of the two populations. Of the ten included studies, only one (musculoskeletal) found a significant interaction effect in favor of the eHealth program and three (musculoskeletal and breast cancer) showed a significant time-effect of the eHealth intervention. In both populations user-friendliness of the tool was considered as a facilitator, the length of the program and the lack of an in-person session as barrier. Due to the absence of a direct comparison, no conclusion can be made on how the effectiveness differs between both populations. OUTLOOK: Further research should incorporate patient-experienced barriers and facilitators and there is a high need of studies making the direct comparison of the effect of an eHealth self-management intervention on pain intensity in an oncological vs. a MSK population.

EffEx-HN trial: study protocol for a randomized controlled trial on the EFFectiveness and feasibility of a comprehensive supervised EXercise program during radiotherapy in Head and Neck cancer patients on health-related quality of life.

BACKGROUND: With over 500,000 annually reported cases worldwide, head and neck cancer (HNC) is the seventh most common type of cancer worldwide. Treatment of HNC with chemoradiotherapy frequently results in serious impairments in physical and psychosocial functioning. Besides, HNC patients typically start their cancer treatment already with poor physical and psychosocial health. It has been shown that a sufficient level of physical activity (PA) before, during, and after cancer treatment is associated with fewer negative treatment-related side effects and a better quality of life (QOL). In order to prevent worsening of functioning and limit the physical impact of the HNC treatment, a comprehensive supervised exercise program (CSEP) may be beneficial during early cancer treatment. However, up to now, the feasibility and effectiveness of such a program are not yet investigated thoroughly in HNC. Therefore, the primary objective of this study is to examine the effectiveness of a CSEP during HNC treatment, in addition to usual supportive care, compared to usual supportive care alone, on health-related QOL up to 1 year post-diagnosis. Secondary objectives entail gathering information on (1) the effectiveness of a CSEP on secondary outcomes such as physical and mental function, activities of daily life, and participation in society and (2) the feasibility, possible barriers, and facilitators for participation in a CSEP during HNC treatment. METHODS: To investigate the effectiveness of the CSEP, a parallel, open-label randomized controlled trial will be performed. To study the feasibility of the CSEP, a mixed-method study will be performed in a subgroup of participants. HNC patients are eligible if they receive radiotherapy at the Radiation-Oncology department of the University Hospital of Leuven. A 4-size permuted block randomization will be used. The control group receives the current standard of supportive care. The intervention group receives a CSEP, additional to the same usual supportive care. The CSEP consists of a 12-week intensive phase with 3 exercise sessions of 1 h per week, where supervision is gradually reduced after 6 weeks. During the maintenance phase (from week 13), patients exercise at home with monthly tele-consultations with a physiotherapist. The CSEP contains supervised aerobic and resistance training. In both groups, outcomes of interest are evaluated through self-reported questionnaires and clinical assessments, at baseline, 6 weeks, 12 weeks, 6 months, and 12 months post-diagnosis. The primary endpoint is health-related QOL, measured with the EORTC QLQ-C30 at 6 months post-diagnosis. DISCUSSION: The study will be conducted in accordance with the Declaration of Helsinki. This protocol has been approved by the ethical committee of the University Hospitals Leuven (s65549). Recruitment started in January 2022. Results will be disseminated via peer-reviewed scientific journals and presentations at congresses. TRIAL REGISTRATION: Trial Registration: ClinicalTrials.gov Identifier: NCT05256238 Date of registration: February 25, 2022.

The Effectiveness of Fluoroscopy-Guided Manual Lymph Drainage as Part of Decongestive Lymphatic Therapy on the Superficial Lymphatic Architecture in Patients with Breast Cancer-Related Lymphoedema: A Randomised Controlled Trial.

The objective of this trial was to investigate the effectiveness of fluoroscopy-guided manual lymph drainage (MLD), as part of decongestive lymphatic therapy (DLT), on the superficial lymphatic architecture in patients with chronic mild to moderate breast cancer-related lymphoedema (BCRL). This trial was a multicentre, double-blind, randomised controlled trial involving 194 participants with BCRL. Participants were randomised into (1) DLT with fluoroscopy-guided MLD (intervention group), (2) DLT with traditional MLD (control group), or (3) DLT with placebo MLD (placebo group). Superficial lymphatic architecture was evaluated as a secondary outcome, visualised by ICG lymphofluoroscopy at the baseline (B0), post-intensive (P), and post-maintenance phases (P6). Variables were (1) number of efferent superficial lymphatic vessels leaving the dermal backflow region, (2) total dermal backflow score, and (3) number of superficial lymph nodes. The traditional MLD group showed a significant decrease in the number of efferent superficial lymphatic vessels at P (p = 0.026), and of the total dermal backflow score at P6 (p = 0.042). The fluoroscopy-guided MLD and placebo group showed significant decreases in the total dermal backflow score at P (p < 0.001 and p = 0.044, respectively) and at P6 (p < 0.001 and p = 0.007, respectively); the placebo MLD group showed a significant decrease in the total number of lymph nodes at P (p = 0.008). However, there were no significant between-group differences for the changes in these variables. In conclusion, based on lymphatic architecture outcomes, the added value of MLD, in addition to the other parts of DLT, could not be demonstrated in patients with chronic mild to moderate BCRL.

The effect of myofascial and physical therapy on trunk, shoulder, and elbow movement patterns in women with pain and myofascial dysfunctions after breast cancer surgery: Secondary analyses of a randomized controlled trial.

INTRODUCTION: Secondary upper limb dysfunctions are common after breast cancer treatment. Myofascial treatment may be a valuable physical therapy modality for this problem. OBJECTIVE: To investigate the effect of myofascial therapy in addition to physical therapy on shoulder, trunk, and elbow movement patterns in women with pain and myofascial dysfunctions at the upper limb after breast cancer surgery. DESIGN: A double-blinded randomized controlled trial. SETTING: Rehabilitation unit of a university hospital. PARTICIPANTS: Forty-eight women with persistent pain after finishing breast cancer treatment. INTERVENTIONS: Over 3 months, all participants received a standard physical therapy program. The experimental (n = 24) and control group (n = 24) received 12 additional sessions of myofascial therapy or placebo therapy, respectively. MAIN OUTCOME MEASURES: Outcomes of interest were movement patterns of the humerothoracic joint, scapulothoracic joint, trunk, and elbow, measured with an optoelectronic measurement system during the performance of a forward flexion and scaption task. Statistical parametric mapping (SPM) analyses were used for assessing the effect of treatment on movement patterns between both groups (group × time interaction effect). RESULTS: A significantly decreased protraction and anterior tilting was found after experimental treatment. No beneficial effects on movement patterns of the humerothoracic joint, trunk, or elbow were found. CONCLUSION: Myofascial therapy in addition to a 12-week standard physical therapy program can decrease scapular protraction and anterior tilting (scapulothoracic joint) during arm movements. Given the exploratory nature of these secondary analyses, the clinical relevance of these results needs to be investigated further.