Symptoms and General Pathology

All Conditions

Blood and Lymph Conditions

Neoplasms

Skin and Connective Tissue Diseases

Syndrome

Lymphedema

Mobility Limitation

Pain

Breast Neoplasms

Breast Cancer Lymphedema

Lymphatic Diseases

Postoperative Complications

The intervention group will receive Myofascial Massage Therapy specific to breast/chest/shoulder of the affected side(s). These massages will include a variety of techniques specifically aimed at reducing pain, inflammation, and tissue sensitivity while also increasing mobility by breaking up scar tissue and thick fibrosis. The intervention massages will include the following specific techniques: skin glide, j stroking, vertical stroking, strumming, fascial stretch, circular friction, deep fascial restriction release, arm pull, side latissimus dorsi stretch, twisting, moist heat application, cold therapy, and lymphatic drainage. These massages will be twice a week at 30 minutes per massage for a period of 2 months after study enrollment.

The control group will receive a general full body massage referred to as a Global Relaxation massage. The massage technique used here will be relaxation massage, avoiding the breast/chest/arm area. This includes light kneading and stroking in order to restore a sense of well- being. The relaxation massage will also be twice a week at 30 minutes per massage for a period of 2 months, avoiding the area of the affected shoulder/shoulders. In this way they are still being seen and touched by a massage therapist, without receiving the intervention treatment.

Myofascial Massage Therapy is a manual massage therapy consisting of the following techniques: fascial stretch, circular friction, deep fascial restriction release, arm pull, side latissimus dorsi stretch, twisting, moist heat application, cold therapy, and lymphatic drainage.

Myofascial Massage Therapy

Global Relaxation Massage is a manual massage therapy consisting of a full body relaxation massage that includes light kneading and stroking in order to restore a sense of well- being

Global Relaxation Massage

Ashwini Sehgal, MD

The aims of this study are to determine the effectiveness of myofascial massage specific to the breast/chest/shoulder area in reducing self-reported pain and increasing mobility among patients who have undergone a mastectomy or other breast surgery compared to a control group receiving global relaxation massages.

Post-operative breast surgery patients may face an array of complications. Breast surgery can include biopsy, lumpectomy, mastectomy or some type of reconstruction (Drackley 2012). Chronic pain and lack of mobility in the chest and/or shoulder are two of the more common and persistent issues in this population, however it is still unclear as to how many actually suffer from these (Wallace 1996). Current treatment for each of these usually includes prescribed narcotic pain medication and/or some physical therapy, the first being a treatment with many side effects, the latter being quite expensive. Global and integrated massage techniques have been used as a way of decreasing stress, anxiety, and some self-reported pain, however a targeted massage technique geared towards the breast/chest/shoulder region has not been rigorously evaluated (Drackley 2012). Myofascial massage has been shown to be an effective treatment for other post-surgical patients in reducing pain and increasing mobility, but efficacy has yet to be shown specifically in post-breast surgery patients (FitzGerald 2009). If proven effective, myofascial massage could be used as an inexpensive and non-invasive addition to current pain and mobility treatment (Cassileth 2004).

Specific Aims

Aim A.

Determine the effectiveness of myofascial massage specific to the breast/chest/shoulder area in reducing self-reported pain among patients who have undergone a mastectomy or other breast surgery.

Aim B.

Determine the effectiveness of myofascial massage specific to the breast/chest/shoulder area in increasing self-reported mobility in the affected shoulder among patients who have undergone a mastectomy or other breast surgery.

Hypothesis: Compared to control patients receiving general full body massage, myofascial massage specific to the breast/chest/shoulder area reduces pain and increases mobility in patients who have undergone breast surgery.

Massage for Post Breast Surgery

Massage for Pain and Mobility in Post-Breast Surgery Patients

Self report survey of current pain type and intensity will be given at the beginning of enrollment and then again after the 2 month study period ends. Pain scores will be measured pre and post.

Self report survey of current mobility issues and restrictions in relation to the breast/chest/shoulder area will be given at the time of enrollment and after the 2 month study period.

MetroHealth Medical Center

Director, Center for Reducing Health Disparities

Neoplasm Metastasis

Skin Diseases

Breast Diseases

Lymphovenous anastomosis surgery with pre-operative planning using ICG lymphography and ultra high frequency ultrasound.

Pre-operative planning prior to lymphovenous anastomosis using ICG lymphography and ultra high frequency ultrasound for mapping of applicable vessels.

During surgery, mapped vessels are freely dissected and anastomosed.

Lymphovenous anastomosis

Caroline Lilja, MD

Jens Ahm Sørensen, MD, Prof, PhD

Jørn Bo Thomsen, MD, Prof, PhD

The primary aim of this study is to investigate and test whether the use of combined indocyanine green (ICG) lymphography and ultra high frequency ultrasonography can correctly identify lymphatic vessels and venoles in close proximity to each other, for identification prior to lymphovenous anastomosis (LVA) surgery.

BACKGROUND

Breast-cancer related lymphedema is a life-disabling side-effect of breast cancer treatment, affecting more than 1 in every 5 patients. With breast-cancer being the most common cancer diagnosis in women, affecting up to 2.3 million new cases globally, and with a generally high survival rate of 80% or higher in developed countries, the number of breast-cancer survivors with long-term sequela is significant. Compression garments have been considered the standard treatment and rehabilitation for lymphedema. Some of the disadvantages with these treatments include variability in patient compliance, clinical effect and lack of statistical significant results. Therefore, the rehabilitation and treatment options for lymphedema are in high demand, affecting patients physical and mental health.

Lymphovenous anastomosis (LVA) surgery is an attempt to re-establish the lymphatic flow, utilizing the patient's own lymphatic- and venous vessels. Surgical treatment seems effective in selective patient groups, but systematic studies for this are lacking. It is based on this lack of knowledge of patient characteristics and preoperative planning that the project's hypothesis and idea was formed.

Indocyanine green (ICG) lymphography is commonly used for identification of lymphatic vessels pre-operatively, and is considered superior to other modalities. However, until recently, the identification of adjacent venoles has remained a challenge. Ultra high frequency ultrasound may have solved the challenge of identifying the small venoles prior to surgery. The combined use of ICG lymphography and ultra high frequency ultrasound may be the key to optimise patient selection and pre-operative planning of lymphovenous anastomosis surgery.

METHOD

This study is designed as a pilot study with a planned inclusion of 10 patients with a 3 months follow-up period.

The inclusion of patients, the surgical procedure and 3 months follow-up evaluation will take place at the Department of Plastic Surgery Odense University Hospital (OUH), Denmark.

The ICG lymphography is performed by injecting ICG subcutaneously, and used for visualization of the superficial lymphatics for preoperative planning. During real-time visualization, lymphatic vessels are drawn up on the patients arm using a permanent marker.

Ultra high frequency ultrasound (\>30MHz) has the ability to visualize small, superficial anatomical layers. Using this ultra high frequency ultrasound (70MHz), following the mapped lymphatic vessels, venous vessels are found nearby and likewise mapped for anastomosis.

The number of LVA anastomosis sites is set to a minimum of two sites per extremity. The number of mapped lymphatics vessels and venoles are compared to the number identified during surgery and recorded.

Prior to and 3 months after surgery, patients are seen for objective measures of upper extremity volume, body composition, L-Dex score of the affected arm and health-related quality-of-life, in addition to ICG lymphography.

Lymphaticovenous Anastomosis as Treatment for Lymphedema

Lymphaticovenous Anastomosis as a Surgical Treatment for Breast Cancer-Related Lymphedema

The number of mapped lymphatics vessels and venoles.

The number of vessels found during surgery. This number will be compared to the number of vessels planned for surgery.

The change of arm volume difference at baseline and at three months follow-up after surgery.

Volume calculation Manual circumferential measurements are taken from both arms for volume calculation, based on the formula for multiple blunt cones.

Water displacement for volume assessment The water displacement test estimates the volume of the arm, based on lowering the extremity in a basin of water, and calculating the water volume difference in mL. Both extremities are measured.

The change in extracellular fluid (liters), relative to total body water (liters), measured by a stand-on bioimpedance at baseline and 3 months follow-up. The stand-on device measure the body composition through small electric impulses between two electrodes.

Extracellular fluid and total body water measures will be aggregated to one reported value (extracellular fluid (liters) / total body water (liters)).

The change in intracellular fluid (liters), relative to body water (liters), measured by a stand-on bioimpedance at baseline and 3 months follow-up. The stand-on device measure the body composition through small electric impulses between two electrodes.

Intracellular fluid and total body water measures will be aggregated to one reported value (intracellular fluid (liters) / total body water (liters)).

The change in total body water (liters), relative to body weight (kg), measured by a stand-on bioimpedance at baseline and 3 months follow-up. The stand-on device measure the body composition through small electric impulses between two electrodes.

Total body water and weight measures will be aggregated to one reported value (total body water (liters) / weight (kg)).

The change in proteins and minerals (kg), relative to body weight (kg), measured by a stand-on bioimpedance at baseline and 3 months follow-up. The stand-on device measure the body composition through small electric impulses between two electrodes.

Proteins and minerals and weight measures will be aggregated to one reported value (proteins and minerals (kg) / weight (kg)).

The change in fat mass (kg), relative to body weight (kg), measured by a stand-on bioimpedance at baseline and 3 months follow-up. The stand-on device measure the body composition through small electric impulses between two electrodes.

Fat mass and weight measures will be aggregated to one reported value (fat mass (kg) / weight (kg)).

The change in active tissue mass (kg), relative to body weight (kg), measured by a stand-on bioimpedance at baseline and 3 months follow-up. The stand-on device measure the body composition through small electric impulses between two electrodes.

Active tissue mass and weight measures will be aggregated to one reported value (active tissue mass (kg) / weight (kg)).

The change in skeletal muscle mass (kg), relative to body weight (kg), measured by a stand-on bioimpedance at baseline and 3 months follow-up. The stand-on device measure the body composition through small electric impulses between two electrodes.

Skeletal muscle mass and weight measures will be aggregated to one reported value (skeletal muscle mass (kg) / weight (kg)).

L-Dex score is a measurement of extracellular fluid of the arm. A stand-on bioimpedance device, estimates the extracellular fluid trough electric impulses between its electrodes. Based upon the impedance ratio of the affected and unaffected arm, the bioimpedance calculates a Lymphedema index, called L-Dex ratio score. A number between -10 and 10 is considered normal, and diagnostic for lymphedema if above 10. Its sensitivity and specificity are 0.66 and 0.99, respectively, at a receiver operating characteristic curve (ROC) value of 10. The score correlates with the limb volume and lymphatic function.

The LYMPH-Q Upper extremity module questionnaire is a validated patient-reported outcome tool for women with breast cancer related lymphedema. The module contains seven individual scales, measuring: symptoms, function, appearance, psychological function, and satisfaction with information on lymphedema and satisfaction with arm sleeve. Each scale gives an independent score reaching from 0 (worst) to 100 (best), which can be used for comparison of change over time. A higher score indicates a better outcome.

Patients will complete the questionnaire at baseline and 3 months follow-up.

Video recordings of ICG lymphographies are stored for later classification of the lymphedema. Staging will be done using the MD Anderson scale; a classification system based upon pattern recognition of the dermal backflow from the ICG lymphography, see table 1.

MD Anderson stage ICG lymphography findings Stage 0 No dermal backflow Stage 1 Many patent lymphatics and minimal dermal backflow Stage 2 Moderate number of patent lymphatics and segmental dermal backflow Stage 3 Few patent lymphatics with extensive dermal backflow Stage 4 Dermal backflow involving the hand Stage 5 ICG does not move proximally to injection site Table 1: MD Anderson classification based upon ICG lymphography findings.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Massage for Post Breast Surgery	NCT02250898	Postmastectomy ... Pain Shoulder Mobili... Breast Surgery	Myofascial Mass... Global Relaxati...	21 Years - 79 Years	MetroHealth Medical Center
Lymphaticovenous Anastomosis as Treatment for Lymphedema	NCT05441943	Breast Cancer L... Secondary Lymph... Iatrogenic Lymp... Lymphedema Lymphedema of U... Lymphedema Arm Lymphedema, Bre... Breast Neoplasm Neoplasms Breast Cancer Breast Diseases Lymphatic Disea... Skin Diseases Postoperative C... Pathologic Proc... Anastomose Surgery Surgical; Lymph... Postmastectomy ... Postmastectomy ... Postmastectomy ... Postmastectomy ...	Lymphovenous an...	18 Years -	Odense University Hospital
Lymphaticovenous Anastomosis as Treatment for Lymphedema	NCT05441943	Breast Cancer L... Secondary Lymph... Iatrogenic Lymp... Lymphedema Lymphedema of U... Lymphedema Arm Lymphedema, Bre... Breast Neoplasm Neoplasms Breast Cancer Breast Diseases Lymphatic Disea... Skin Diseases Postoperative C... Pathologic Proc... Anastomose Surgery Surgical; Lymph... Postmastectomy ... Postmastectomy ... Postmastectomy ... Postmastectomy ...	Lymphovenous an...	18 Years -	Odense University Hospital

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