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The Head & Neck Program is just 32 minutes long. /TT1 70 0 R I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. /Parent 2 0 R They wanted me to come there three times a week for 3 hours to be wrapped and have therapy. >> Tactile Medical takes pride in the fact that our solutions help increase clinical efficacy, reduce overall healthcare costs and improve the quality of life for patients with chronic conditions. S To evaluate function based upon cervical and shoulder range of motions measurements from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. They are usually called something like 7 on your side or Channel 3 helps you. /Resources << /A << << Words like new kind of pump, different than the old types, favorable studies, and Dr. One week at the wound care clinic , I saw a different doctor than normal and he referred me to tactile. /C2_1 55 0 R Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. 2. Search. /Filter /FlateDecode /TT3 72 0 R A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. /CS /DeviceRGB endstream Developing Lymphedema and not being able to get the help that I neededwas awful. 4? XJ 2013; Vol. endobj I?m 5? >> Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. My interest in pumps suddenly skyrocketed! >> More than 90% of patients treated for head and neck cancer develop lymphedema1 resulting in swelling, fibrosis, difficulty swallowing, pain and other symptoms impacting quality of life with few viable options for long-term treatment, said Dr. Thomas F. ODonnell, Jr., Tactile Medicals Chief Medical Officer. /S /Transparency Flexitouch Plus is an advanced intermittent pneumatic compression device (lymphedema pump) that gives patients a comfortable and convenient way to self-manage lymphedema and non-healing venous leg ulcers. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. /C2_0 21 0 R document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); This site uses Akismet to reduce spam. G Bg4> +o_j-\#a4B5C;dOw[['q=oJ&9{4d`Jn"\u|MTbzzG,g L|F4/^z7D:tL$TrHxarg5>Lpp The Flexitouch Plus system should not be used on patients with one or more of the following conditions: The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema. Sort by. I have had a DMX, chemo, radiation and will be taking medication for the next 10 years that causes swelling. Non-cancer related lymphedema patients demonstrated a: 75% decline in the rate of cellulitis, a 40% reduction in the rate of out-patient hospital visits, a 34% reduction in rate of physical therapy visits, and a 36% reduction in lymphedema-related costs. /MediaBox [0.0 0.0 612.0 792.0] The initiation of this clinical trial underscores Tactile Medicals commitment to supporting the development of quality clinical evidence and expanding access to effective lymphedema treatment for this underserved patient population., For additional information about the trial, please visit: https://tactilemedical.com/head-and-neck-lymphedema-clinical-trial/, Lymphedema is a chronic disease in which excess fluid accumulates in areas of the body when lymphatic vessels do not work efficiently or have been damaged. It seems a lot of pumps are preprogrammed for the individual. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. /ProcSet [/PDF /Text /ImageC] https://tactilemedical.com/head-and-neck-lymphedema-clinical-trial/, https://tactilemedical.com/information-for-patients/what-is-lymphedema/, https://tactilemedical.com/our-lymphedema-solutions/for-head-and-neck/flexitouch-plus/. /GS0 37 0 R Thumbs up for Flexi-Touch!! Phone: 1.612.355.5100 https://doi.org/10.1007/s00520-020-. I didnt need a lymphedema physical therapist but too much to explain here. /URI (http://www.fda.gov/) I chatted with a woman from Tacoma and another from Idaho. /StructParents 7 /A << The garments have already been measured for me at the PT office but the Company wont allow me to purchase them from them. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. How customer reviews and ratings work See All Buying Options. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. The Flexitouch system and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema. They use them in the morning, at nightand feel very lucky.. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. Its New, Your email address will not be published. /Font << Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum. << eIb? Yay! 2015 51 (431-437), 1. /Annots [25 0 R 26 0 R 27 0 R 28 0 R 29 0 R 30 0 R 31 0 R 32 0 R 33 0 R 34 0 R Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. Choosing to participate in a study is an important personal decision. The Flexitouch Plus system is clinically proven to decrease swelling and improve swallowing. JAMA Dermatol. Important Notice: The contents of the website such as text, graphics, images, and other materials contained on the website ("Content") are for informational purposes only. Hi Sarah, I would suggest going to a clinic in your area where therapists specialize in care of lymphedema. /Group << I would be interested to hear how your husbands experience with his new pump. /Contents 36 0 R View this study on Beta.ClinicalTrials.gov, Study Protocol and Statistical Analysis Plan, U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Positive value shows an increase in Function/Range of Motion. To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. 11 0 obj Actually they dont know much about lymphedema. And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. >> The Companys unique offering includes advanced, clinically proven pneumatic compression devices, as well as continuity of care services provided by a national network of product specialists and trainers, reimbursement experts, patient advocates and clinicians. Tactile Systems Technology, Inc. Negative value shows a decrease in Function/Range of Motion. Free shipping for many products! In head and neck cancer, lymphedema can be caused by: Surgery: When lymph nodes and vessels are removed during surgery for cancer, it becomes harder for the body to move lymph fluid out of the area. Tens of thousands of. This outcome data will include information regarding each subject's medical history, symptoms, quality of life, pain, range of motion (ROM), swelling, ease of use, treatment satisfaction, treatment compliance, and adverse events. >> Percent change is calculated by the difference between scores averaged at 6 months versus baseline. For these patients, Flexitouch Plus for head and neck lymphedema is the first and only pneumatic compression device cleared and commercially available to treat this condition at home. I have skipped 1 or 2 days just 3 or 4 times since March. I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. The content is not intended to substitute manufacturer instructions. With the enrollment of our first patient, we are pleased to initiate the largest randomized, controlled clinical trial ever conducted for the treatment of head and neck cancer-related lymphedema, said Sheila Ridner, PhD, RN, FAAN, Professor of Nursing, Emerita, Vanderbilt University School of Nursing, a principal investigator of the trial. /Parent 2 0 R The pump, created by Tactile Medical, provides compression to the skin which is a key to treating. /TT0 49 0 R /Filter /FlateDecode I would suggest you keep contacting Tactile Medical. (Note: There are other well regarded pumps on the market. Study record managers: refer to the Data Element Definitions if submitting registration or results information. They are in contact with patients who could benefit from a pneumatic pump. I didnt make a decision to purchase a pump that day. Thanks. Negative value shows a decrease in pain. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. Hope it works out. In June 2017, we announced that we received 510(k) clearance from the FDA for the Flexitouch Plus, the third-generation version of our Flexitouch system. In conducting this rigorous clinical trial, we hope to build on the initial body of evidence by evaluating the effectiveness of Flexitouch Plus in comparison to usual care, using a variety of measures to assess the benefits of this at-home treatment for patient health and quality of life.. While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. >> The feeling of devloping a chronic disease after surviving cancer was almost debilitating. I used it a few times and Im good now. The Companys unique offering includes advanced, clinically proven pneumatic compression devices, as well as continuity of care services provided by a national network of product specialists and trainers, reimbursement experts, patient advocates and clinicians. Learn how your comment data is processed. Rockson floated to my ears. >> Support Care Cancer (2020). << Anyway, we are excited and hopeful this will be a part of our answer for his lymphedema. Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. did you sell it yet? Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. 14(4): p. 198-205, 2. endobj /Font << Dr. Arturo Gonzalez and Dr. Alton R. Johnson, Cathy Thomas Hess, BSN, RN, CWOCN and Dr. Lisa Gould, MD, PhD, FACS, IC-1200-WH Vascu-Ease Portable DVT System, Recommendations for Wounds After Flaps and Grafts, How to Leverage Technology to Improve Patient Education and Outreach, From Chronic to Closure: An Innovative Approach to Manage Challenging Wounds, Working Smarter, Not Harder: Strategies for Wound Management Success, How to Advance Complex Wounds Toward Healing, Implementing Wound Hygiene: A Stepwise Approach, Uncommon Wounds: Frostbite and Winter Woes, What Clinicians Should Know About Comorbidities and Complex Wounds. I have had it some 10 years now and when it gets to the point of cellulitis I take medication which I feel is not the thing to do but it takes the pain away and eventually relieves the fever and some of the swelling. I have lymphedema near globally at this point and am trying to obtain coverage via insurance. Negative value shows a increase in quality of life. endobj /TT2 51 0 R >> Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. /TT0 22 0 R ?gF:cmlrpoc*teIgeF%hvK-h*NHw\3b.IkQvll Bwzw6Gix-Gm6!57Z4T$YNN Positive value shows an increase in symptoms/problems. Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed Outcome Measures Go to Primary Outcome Measures : Symptom/Problem Improvement From Baseline to 6 Months [ Time Frame: Percent Changes between Baseline and 6 months will be assessed ] /Length 450 Support Care Cancer (2020). /Annots [10 0 R 11 0 R 12 0 R] I feel like my physical therapist or the sales rep from Tactile Medical should have caught this BEFORE I was encouraged to order an expensive machine that I may or may not be able to use. I have lymphedema in my right arm, breast and axilla. /MediaBox [0 0 612 792] 17 0 obj D/N500187-000-00 Rev. I need help but theres a no return policy. x Minneapolis, MN 55416 USA Hi Deborah, How wonderful you have had such positive success with your pump. /Type /Page 13 0 obj /Resources << Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. Its been tough . Learn More Take the steps now to help your head and neck cancer survivors. History of the Northwest Lymphedema Center. The trial will compare the short- and long-term effectiveness of Tactile Medicals Flexitouch Plus system to usual care, such as complete decongestive therapy (CDT), for the management of lymphedema and fibrosis in head and neck cancer survivors. Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. Its something Im passionate about. /Subtype /Link I have lymphedema due to a mastectomy and 15 lymph nodes removed from my left arm. /Resources << The leg garments that I received are for a much taller person. /S /URI doi.org/10.1007 /s00520-020-05540-8, First-ever randomized control trial of home management of head and neck lymphedema, Retrospective analysis of 205 Flexitouch user survey responses, Near-infrared fluorescence lymphatic imaging (NIRFLI) before and after Flexitouch use, Flexitouch Plus is the only FDA cleared pneumatic, See the clinical benefit of Flexitouch Plus, Longitudinal Patient Reported Outcomes Study. /XObject << For more information, https://tactilemedical.com/about-us/. /Tabs /S endobj Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. /Im0 60 0 R Upper set (head and neck). 7nwJ@6]?t~.} You have reached the maximum number of saved studies (100). /MediaBox [0 0 612 792] stream Flexitouch Plus is an advanced intermittent pneumatic compression device (lymphedema pump) that gives patients a comfortable and convenient way to self-manage lymphedema and non-healing venous leg ulcers. /Tabs /S /StructParents 2 But in reading the users manual I found that you should consult your physician before using a FlexiTouch garment that covers your chest if you have a tissue expander. /Subtype /Link Thanks. HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ I like to joke, Honey, time for me to put the squeeze on you See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use /Font << Text, image, video. 2 0 obj It was up to me to piece it together. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. My lymphedema therapist also told me that the pumps werent worth it.