CLINICAL RESEARCH ON LYMPHATOUCH

Transcription

1 CLINICAL RESEARCH ON LYMPHATOUCH PEER REVIEWED CONFERENCE AND JOURNAL PUBLICATIONS Therapeutic Excellence FOR FASTER RECOVERY Formerly PhysioTouch

2 1. Negative pressure therapy in the management of lymphoedema Frederick Hulme Gott, Kathleen Ly, Neil Piller and Andrea Mangion Journal of Lymphoedema, June 2018 Vol 13 Issue 1 Lymphoedema involves chronic tissue inflammation with tissue changes that include extracellular free fluid accumulation, tissue fibrosis and fatty tissue deposition (Zampell, 2012). Despite the best efforts of modern conservative lymphatic therapy, some patients will progress to develop significant secondary tissue changes with morbidity evident via recurrent bouts of cellulitis, reduced function and lowered quality of life. Fatty tissue deposition can contribute to such severity that liters of accumulated fatty tissue warrant surgical management via liposuction (Brorson 2006). Non-invasive and painless technology should, therefore, be of interest to lymphatic therapists aiming to improve the outcomes of conservative lymphatic therapy. Historically, conservative lymphatic therapy treatments have consisted of treatments that predominant via offering positive pressure; a pushing force onto the tissues. Compression bandaging, pressure garments, including wraps and chip bags, and massage, including massage, including manual lymphatic drainage and pneumatic compression devices, represent examples of positive pressure therapy and technology. Negative pressure, on the other hand, is a newer means offering treatment, whereby a pulling or opening force is applied to the tissues. Treatment can be targeted to specific areas, such as areas of radiation induced fibrosis and scar tissue, or the technology can be used as an adjunct to massage and manual lymphatic drainage. Brands such as LymphaTouch(LymphaTouch Inc) and Endermologie (LPG) are examples of negative pressure massage devices designed for use by manual therapist. This article introduces technology to lymphoedema management and the proposed mechanics of action. 2. Occupational Therapy Treatment to Improve Upper Extremity Function in Individuals with Early systematic Sclerosis: A Pilot Study Susan L. Murphy, Mary Barber, Kristen Homer, Carole Dodge, Gary Cutter, Dinesh Khanna Doi: /acr.23522, January 2018 Objective: To determine feasibility and preliminary effects of an occupational therapy treatment to improve upper extremity (UE) function in patients with early systemic sclerosis (SSc) who have UE contractures. Methods: A one-arm pilot clinical rehabilitation trial was conducted at a university health system. Participants with SSc and 1 UE contractures (N=21) participated in a total 8 weekly in-person occupational therapy sessions. The therapy consisted of thermal modalities, tissue mobilization, and UE mobility. Between sessions, participants were instructed to complete UE home exercises. Feasibility was measured by present enrollment and session attendance and duration. The primary outcome measure was QuickDASH, secondary and exploratory outcomes included PROMIS physical function, objective UE measures, and skin thickening. Linear-mixed models were performed to determine treatment effects on primary and secondary outcomes.

3 Results: Fifty percent (24/48) of potentially eligible participants were interested. Of those, 88 % (21/24) enrolled: and nineteen out of 21 (91%) completed the sessions. The mean (SD) age was 47,9 years (±16.1) ; 100 % had diffuse SSc, and mean disease duration was 3.1 years. At 8 weeks, participants reported statistically significant improvement on QuickDash and PROMIS physical function measures (p=.0012 and p=.00). Forty seven and 53 % percent of the sample achieved improvements that exceeded minimally important difference. Conclusion: In-person treatment sessions were feasible for individuals with SSc and demonstrated statistically significant and clinically meaningful improvements on UE and physical function. Future studies need to examine effects against a control condition and examine durability of treatment effects. 3. Significant improvement in quality of life after treatment of lower extremity lymphedema with negative pressure application Adrien Mackenzie LMT, PTA, CLT-LANA, Paula Donahue, PT, DPT, CLT-LANA 26th World Congress of Lymphology, September 2017 The patient case presented was conducted to assess if CDT combined with PhysioTouch has a patient valued- impact on the patient s expressed pain & quality of life. A 55 year old female diagnosed with secondary Stage III lower limb lymphedema. She received 10 weekly treatments of MLD combined with PhysioTouch treatment, one session lasted 60 minutes. Pain was assessed using the VAS scale, volumetric measurements obtained via perometry, clinical assessment of skin & superficial tissue mobility via palpation, QOL measures: Patient Specific Functional Scale (PSFS ) & Lower Extremity Functional Scale (LEFS). The conclusion was that QOL and pain improved which patient reported and compared to previous courses if CDT treatments. The results indicate that; Pain improved: VAS reduced from 4/10 to 1 /10, PSFS improved by 4 points, LEFS improved by 11 points. 4. Treatment of the Periwound with Intermittent Negative Pressure Jodie Briggs, OTR /L, CLT and Kate McKennedy, PT, CWS, University of Michigan 2016 This whitepaper includes two patient cases presenting negative pressure as an approach in treatment of the periwound. Each patient received standard wound care including a weekly physical therapy visits with pulsed lavage and debridement and weekly occupational therapy visits with use of manual lymphatic lymphatic drainage, using intermittent negative pressure device and compression. Special wound dressings were also applied. The intermittent pressure device was applied to the medial knee and down the lymphatic tracts opening the tracts towards the wound bed. The device was applied around the wound bed on various settings depending on the amount of fibrosis, skin condition and patient sensations. This included altering settings between mmhg, duration of pulse seconds. Vibration was also applied in most fibrotic areas at 20 Hz.

4 5. Negative pressure assisted lymphatic drainage: Improving conservative treatment options Mangion A Asia Pacific Lymphology Conference, 2016 Case study describing the effect of PhysioTouch for secondary bilateral leg lymphedema. The patient presented with a wound, grossly swollen leg and abdomen, lymph blister and functional deterioration. As treatment outcome, significant limb volume reduction was achieved by four session with wound closure by sixth. Improvement was observed also in pain, quality of life and functional ability. When compared with previous treatment models, the PhysioTouch approach did not require bandaging this patient. Also, the therapy was delivered with less therapist fatigue and resources. The case is about a male obese client with secondary bilateral leg lymphedema with acute exacerbation of swelling in his right leg. Treatment Outpatient model of six therapy sessions occurring twice a week included PhysioTouch assisted lymphatic drainage, simple wound care and return to flat knit compression garment wear. 60 minutes of PhysioTouch therapy was administered with graduated suction dosage from mmHg on the abdomen, mmHg on the anterior right leg starting proximally at inguinal nodes and mmHg to posterior right calf and around the wound border. 6. Treatment of radiation induced fibrosis and breast oedema for arm lymphoedema risk reduction Mangion A Asia Pacific Lymphology Conference, 2016 This study highlight a case treatment of a female client of 54 years of age with post-breast cancer lymphedema in her breast. Lymphedema treatment started two years after the cancer surgery. For the first three weeks the treatments were done only with PhysioTouch. Each session lasted one hour. After the initial treatment sessions with PhysioTouch, the client reported a significant increase in comfort when completing daily tasks and felt confident to resume her exercise program. She also reported a significant improvement in her QOL. Female client of 54 years of age who was treated for right breast cancer in May 2013 (invasive ductal carcinoma, Grade 3). Breastcancer intervention included surgery (wide local excision and full axillary clearance). Edema in the right breast was apparent immediately following surgery. Edema continued to be a persistent problem in the right breast, which increased post radiation with further blistering and hardening of the breast tissue. Discomfort around her chest was limiting her ability to complete functional task. Lymphedema treatment started in August Client was encouraged to attend twice weekly, one hour sessions for lymphedema treatment with PhysioTouch. PhysioTouch treatment protocol included central lymphatic drainage of the abdomen and drainage of the right breast using principles of MLD with proximal drainage first. The entire breast was treated over, including over the nipple. To reduce risk of arm lymphedema, adhesions in the right axilla were mobilized directly over with a focus on drainage of the abdomen and the swollen breast. Treatment dosage of negative pressure was increased slowly from 60mmHg up to 120mmHg with a pulsed application (2 sec on, 2 sec off) with a stationary hold technique. The client was treated in supine and in side lying.

5 As a result of PhysioTouch treatments, the client reported a significant increase in comfort when completing daily tasks and felt confident to resume her exercise program. She reported a significant improvement in her QOL. Shoulder ROM normalized to allow for further treatments to be completed with the arm relaxed in full abduction. The breast had softened significantly with color beginning to fade gradually from dark brown to pink. The change in color was particularly of interest as the client reported being informed by her radiology team that the breast would remain brown considering the extent of her radiation. The change was that significant post treatment that the client booked an additional appointment with her radiologist to demonstrate the change in her breast color and ability of her breast to move on her chest wall. Also, of interest was the palpable difference in temperature of the breast, which was palpably less warm after treatment (an observation not noticed routinely in other clients with breast lymphedema after standard MLD, and an expected result when considering that the tissues were being mobilized which would theoretically increase healthy blood flow to the area). Considering the inflammatory nature of lymphedema, further studies objectively assessing change in tissue temperature post PhysioTouch treatment in areas that are actively continuing to fibrose post radiation, would be interesting. 7. Observation of blood inflammatory markers in chronic lymphoedema Mangion A Asia Pacific Lymphology Conference, 2016 This case observes an obese client s blood inflammatory markers through CLT intervention, following several admissions to hospital for cellulitis and a home management model of care. PhysioTouch treatment was administered once per week. Blood tests were taken on a weekly basis via GP home visits. Trends in the blood inflammatory markers were tracked over time nflammatory markers decreased after several weeks of conservative therapy to rise when conservative therapy was halted. The case describes 76 year old bed bound overweight client with secondary bilateral leg lymphoedema. Oral antibiotics and weekly injections were part of the cellulitis management plan considering several lengthy inpatient admissions in 2014 for cellulitis. A local lymphedema therapist completed home therapy on a once a week basis. Treatment consisted of PhysioTouch assisted MLD and skin care in one hour appointments. Blood tests were taken on a weekly basis via GP home visits. Trends in the blood inflammatory markers were tracked over time. PhysioTouch treatment protocol included central lymphatic drainage of the abdomen and drainage of both legs using principles of Manual Lymphatic Drainage with proximal drainage first. The entire lower legs were treated over including scarring on the right ankle and areas of tissue inflammation on the anterior shins. Treatment dosage of negative pressure was increased slowly from 20mmHg up to 80mmHg with a pulsed application (2 sec on, 2 sec off) with a stationary hold technique. The client was treated in supine on her home hospital bed. Significant changes in the inflammatory markers was noted during the therapy. ESR levels were consistently over 40 H prior to therapy intervention, reaching 22H (normal limits 1-35) during therapy. CRP levels were consistently over 10 to decline to 8.2mg/L during therapy. Due to the therapist unavailability, the therapy was halted for 2.5 weeks. Subsequent readings demonstrated that the ESR had risen to 60H and the CRP to 16.4mg/L.

6 8. Modeling of interstitial fluid movement in soft tissue under negative pressure relevance to treatment of tissue swelling JT. Iivarinen, RK. Korhonen, and JS. Jurvelin, DOI: / Computer Methods in Biomechanics and Biomedical Engineering, 2015 Journal publication that uses computer based finite-element model of soft tissue to analyze how pulsating and continuous modes in LymphaTouch device affect fluid flow, velocity, and pressure. The model response was matched with negative pressure (suction) measurements in human (N=11) forearm. Two experimental suction protocols were simulated to evaluate their impact on interstitial fluid flow in soft tissues. Simulated continuous suction was up to 27 times more efficient in fluid transportation compared to the cyclic suction. A finite-element model was created using pqct imaging and by doing measurements of soft tissue response to negative pressure on 11 healthy volunteers (9 males, 2 women). The negative pressure and suction protocols were performed using LymphaTouch device and the registered data was analyzed using Matlab software. Two protocols were analyzed, cyclic and continuous. The simulated cyclic procedure consisted of five 100mmHg suctions and 1cm lengthwise movement. The pulsation was set at 2s (one second suction, one second zero-pressure period). Similarly, the continuous treatment protocol consisted of one 100mmHg suction with simultaneous 4 cm (in 4 s) lengthwise movement at a constant speed of the suction head. The study found that the continuous suction method with simultaneous change of treatment position induced higher fluid pressure, velocity transients, and more effective fluid movement along the treatment direction than the cyclic method. It is to be noted that the model does not take into account how negative pressure treatment of edema may affect pressure-dependent promotion of the interstitial fluid flow into lymphatic system and/or activation of the lymphatic system in transportation of lymph fluid. In other words, the role of lymphatic system is not included in the model, meaning that the conclusion stating that continuous mode is more effective for moving fluid, applies better in areas where lymphatic system does not fully work. 9. Can early intervention with PhysioTouch s mechanical leverage in the functioning of initial lymphatic vessels help promote long term physiological homeostasis as well as fluid volume reduction in a locally impacted lymphatic territory Osborne J., 25th World Congress on Lymphology, 2015 Case study that investigates how adding PhysioTouch to lymphedema patient treatment affects fluid reduction. Both circumferential volume and L-Dex BioImpedance measurements were taken. PhysioTouch was shown to create greater radial tension through to anchoring filaments to initial lymphatics (IL) than lymphatic manual drainage, thereby increasing fluid movement from the interstitium into the ILs.

7 Patient was diagnosed with breast cancer in 2012 and underwent mastectomy and expander placement, followed by external beam radiation therapy. At 6 months, expanders were replaced with implants. HR had immediate severe infection (R) implant. Implant was removed within 48 hours. IV antibiotics were administered. Two open chest incisions were surgically made to drain fluid. Drainage wounds drained for 8 months. (R) UE developed Stage 2 lymphedema at onset of infection. CDT was initiated, but with minimally successful results. In 2014 Lymphoscintigraphy results revealed total obstruction of flow through axillary lymph nodes. In August 2014 HR underwent DIEP Flap surgery with Lymph Node Transfer of 4 nodes from abdomen to (R) axilla. Initial results of decreased (R) UE circumferential lymph volume measurements were positive. At 6 months post-surgery, circumferential volume reduction plateaued. PhysioTouch was introduced into the treatment plan in January The specific effectiveness of PhysioTouch is its increased strength, greater than that of LMD (lymphatic manual drainage), in creating radial tension through the anchoring filaments of the ILs, thereby increasing fluid movement from the Interstitium into the ILs. This success in treatment can be objectively measured by both circumferential volume using a tape measure and L-Dex BioImpedance, the latter giving a more accurate clinical picture of relative fluid volume in a limb. Based on L-Dex BioImpedance measurement, PhysioTouch introduction to the treatment plan resulted to nearly 50% reduction in the arm volume in six months. 10. The benefit of one session on a negative pressure device when used in a Manual Lymphatic Drainage (MLD) sequence in primary lymphoedema Whitaker JC, 25th World Congress on Lymphology, 2015 Case study that investigates how PhysioTouch in conjunction with Manual Lymphatic Drainage improves lymphatic drainage for primary lymphedema patient. After one hour treatment, 19% of lost lymphedema was recorded using 4cm tape-measure technique. Also, based on subjective observation tissues were softer and shape improved. A 65 year old lady with unilateral Primary Lymphedema - stage IIb, was given a one hour MLD session using the Casley-Smith technique with a NPD. The NPD was set at 80mmHg. Limb volume measurements using the 4cm tape-measure technique were taken and volumes were recorded in millilitres. Measurements were taken immediately before and directly after the treatment. Actual changes in excess limb volume was measured at 198 ml, which indicated that 19% of the lymphedema had been lost in only one hour. Case study concluded that introducing PhysioTouch to MLD substantially reduces the change in limb volume after just one session. Also, the patient rated the treatment very favourably and requested the continuation of future treatments with this device.

8 11. A clinical audit to demonstrate the use of a negative pressure device in an MLD sequence to improve both clinical and patient perception treatment outcomes Whitaker JC, 25th World Congress on Lymphology, 2015 Case study that investigates how PhysioTouch in conjunction with Manual Lymphatic Drainage improves lymphatic drainage compared to RCT Bandage studies. The case showed that PhysioTouch with MLD achieved in just 4 days comparable change in excess limb volume being than RCT Bandage studies performed over 19 days. (Badger et al, 2000). 65 year old lady with unilateral Primary Lymphedema. PhysioTouch was used on four consecutive days to perform the Casley-Smith MLD method. The lady completed a simple patient self-reported rating scale questionnaire on skin, tissue, visual improvement and range of movement. Limb volumes were recorded using the 4cm tape-measure technique The change in excess limb volume was 39% and absolute limb volume was 5%. The patient s self-valuation showed improvement in all areas questioned and comments noted were very positive. Overall the treatment outcomes measured showed favorable results with the change in excess limb volume being comparable to RCT Bandage studies performed over 19 days. (Badger et al, 2000). Tissues were notably softer and visually reduced in size. Range of movement and fit of clothing from a patient s perspective were also improved. PhysioTouch was found to improve both clinical and patient perceived treatment outcomes. 12. LymphaTouch and PhysioTouch treatment as a part of Active Physioterapy: Effect on Pain and Swelling Hietanen S, Puustinen T, Jouhki I, Palomäki K., Taskinen T., Internal Research Report, 2014 The target of this study was to chart the effectiveness of LymphaTouch and PhysioTouch as part of active and conservative physiotherapy. The study focused on examining the change in pain during the treatment period and in the change in swelling. In addition, the need for pain medication and the change in the need for pain medication was defined. As a basis for the study, preliminary research carried out in 2010 was used. The results of this previous study showed that it was justified to expand the study to this second phase. A total of 37 rehabilitation and physiotherapy professionals participated in the study in Finland. Altogether 202 patient cases were reported from different treatment areas with upper groups of leg, arm, mid-body, and the neck and shoulder area which were then divided in more detail into subgroups based on symptoms. The treatment periods and treatment session durations of the patients varied according to the real treatments. The results have been reported from situations corresponding to heterogeneous and actual treatment situations. The changes in the VAS scale was the factor studied with the most detail in this study. The result was that the VAS change in all the patients groups was significant; 30%. The individual patient experiences of using PhysioTouch and LymphaTouch as part of the treatment course were primarily positive.

9 13. Experimental and computational analysis of soft tissue mechanical response under negative pressure in forearm Iivarinen JT, Korhonen RK, Jurvelin JS. Skin Research & Techology, John Wiley & Sons, DOI: /j x, Vol 19. Issue 1, pp , 2013 Clinical Study analyzing LymphaTouch effect on the skin and fatty tissue in the forearm. 11 healthy subjects had PhysioTouch applied to their forearm. The effects of negative pressure were examined at rest (non-swollen tissue) and then tissue swelling was induced in the forearm by venous occlusion (pressure cuff) to see how this affected the negative pressure effect. Clinical study measures mechanical responses of human forearm soft tissues were measured at rest and under venous occlusion using a LymphaTouch device. A fibrilreinforced hyperelastic (FRHE) model with the geometry obtained from peripheral quantitative computed tomography imaging was created to determine the elastic modulus of skin and adipose tissue, as well as deformational behavior of the skin fibrils, in the forearm. Clinical study specifically found that: (1) the suction device in use observes sensitively the mechanical properties of the skin, especially under large tissue deformation, (2) during manipulated tissue swelling, the skin and the adipose tissue stiffen simultaneously. The study concluded that the PhysioTouch device can be useful when diagnosing and monitoring changes in soft tissue properties and tissue swelling, typical to pathological conditions such as edema. 14. Effect of PhysioTouch treatment on perception of DOMS and recovery after heavy resistance exercise Nummela A. and Mikkola J., Research Institute for Olympic Sports -KIHU, Jyväskylä 2013 Background: Delayed muscle soreness (DOMS) is a familiar experience for the athletes. A number of treatment strategies have been introduced to help alleviate the severity of DOMS and to speed up the recovery of the muscles, but still exercise is most effective means of alleviating pain during DOMS. The present study was planned to investigate where the PhysioTouch treatment alleviates the severity of DOMS, speeds-up the elimination of muscle trauma and inflammatory markers and speeds-up the recovery of force production after heavy resistance exercise in recreational athletes. Methods: A group of 14 recreational strength athletes performed 5 x 10 repeated maximum squat twice: with or without the PhysioTouch treatment (PTT and NOT, respectively) during four days of recovery. The maximal force production was measured with isometric leg press test and countermovement jump before and after the squat exercise and during four days of recovery. Furthermore, muscle trauma and inflammatory markers were measured before and after the squat exercise and four days during the recovery. The blood markers were leukocytes, CK, LDH, Mb, CRP ans cortisol. Subjective perception of DOMS was rated on a visual analog scale from 0 to 100 mm.

10 Results: Maximal isometric force and the height of countermovement jump decreased significantly (P <0.001) but no significant difference was observed between NOT and PPT. Subjective perception of DOMS increased significantly after the squat exercise (P <0.001) and reached the highest value two days after exercise. DOMS was significantly lower in PTT than not three days after squat exercise (P<0.05). All blood markers except CRP increased significantly during squat exercise but there were no significant differences between PTT and NOT (P<0.05). Conclusion: The result of this study indicate that PTT decreased the perception of DOMS after a strenuous squat exercise in recreational strength athletes. However, PTT did not speed up the elimination of muscle trauma markers after squat exercise and PTT did not influence on the recovery of force production in athletes who were to strength training. 15. Lymphatic therapy using negative pressure, A clinical study with the LymphaTouch device Vuorinen V-P, Iivarinen J., Jurvelin J, Airaksinen O. Research Report # /221, Finnish Funding Agency for Technology and Innovation, 2013 A clinical study comparing lymphatic therapy administered on breast cancer lymphedema patients with a negative pressure device to manual lymph drainage (MLD) therapy. Aim was also to verify the physiological effects of LymphaTouch therapy in swollen tissue and to establish the safety of lymphatic therapy administered with the LymphaTouch device. Research showed that LymphaTouch reduced over 3x more limb volume than MLD. Also, patient degree of disability (DASH) reduced by 30% and Quality of Life (FACT-B) improved by 14%. The study consisted of 13 female patients, 7 treated with LymphaTouch and 6 with MLD (Vodder method). Each patient had undergone mastectomy involving removal of the axillary lymph nodes, and been diagnosed with lymphedema of an upper extremity as a result. Both patient groups were treated 10 times by the same therapist. Total treatment time was 90 minutes, out of which 60 minutes was used for lymphatic therapy. The treatment also included arm measurements and standard compression bandaging. The only difference between the two groups was the type of lymphatic therapy administered, either MLD or LymphaTouch. The study was funded by European Union. The results of the treatment were measured using various methods, including volumetric limb measurement, limb circumference, MRI measurement of limb volume, tissue stiffness, and body composition analysis (InBody). Additionally, patient degree of disability was assessed using FACT-B and Quality of Life using DASH questionnaires. The study results showed significant improvement using LymphaTouch over MLD for both objective and subjective measurements. MRI measurement showed over 3x improvement in limb volume reduction (2% MLD vs. 7% LymphaTouch) and skin stiffness was improved by over 4x (2% MLD vs. 9% LymphaTouch). Patient s quality of life was improved nearly 3x more for LymphaTouch group of patients (5% MLD vs. 14% LymphaTouch). While MLD showed no change for degree of disability, LymphaTouch group reported over 30% reduction (0% MLD vs. 30% LymphaTouch).

11 16. Experimental and computational analysis of soft tissue mechanical response under negative pressure in forearm Jarkko T. Iivarinen, Rami K. Korhonen, Petro Julkunen and Jukka S. Jurvelin Skin Research and Technology 2012; :1-10, DOI: /j Background: Instrumentation, relying on the use of negative pressure (suction), has been introduced to reduce pathological tissue swelling. Then relative contribution of skin, adipose tissue and muscle, to overall mechanical response is not known. Method: Under suction, stretch of soft tissues in the forearm of human subjects (N=11) was experimentally measured at rest and under venous occlusion. Three dimensional, fibril-reinforced hyperplastic finite element (FE) model was constructed, the model response was matched with the experimental measurement and mechanical characteristics of each tissue were derived. Parametric analyses were conducted to evaluate the impact of different tissues on the total stretch. Results: The model suggested that, at large strains, the stretch response was more sensitive to changes in the elastic modulus of skin than those in adipose tissue. During venous occlusion, reduction of the stretch of forearm tissues was related to stiffening of the skin and adipose tissue, as evidenced by increased modulus of 27 ±21 % and 35 ± 26 %, respectively. Conclusion: The methods based on suction may be used to diagnose and monitor skin changes in properties of soft tissues, especially those of skin, as well as tissue swelling typical to pathological condition such as edema. 17. Experimental and computational analysis of soft tissue stiffness in forearm using a manual indentation device Jarkko T. Iivarinen, Rami K. Korhonen, Petro Julkunen, Jukka S. Jurvelin Med. Eng Phys (2011), DOI: /j.medengphy A hand held stiffness meter can be used to measure indentation stiffness of human soft tissues, sensitively altered e.g., by pathological tissue swelling. Under indentation load, the relative contribution of each soft tissue component (i.e., skin, adipose tissue and muscle) to the biomechanical response is not known. In the present study, we evaluated the biomechanical role of different soft tissues in relaxed, physically stressed and oedemic human forearm. Soft tissue stiffness of the forearms in nine healthy human subjects was measured under four different test protocols: (1) forearm at rest, (2) forearm under isometric flexor load, (3) forearm under isometric extensor loading, and (4) forearm under venous occlusion. In (2) and (3) the loading forces were monitored using a dynamometer, and in (4) the soft tissue swelling was induced by venous occlusion using a pressure cuff. At the site of indentation, thickness of different tissue layers (skin, adipose tissue and muscle) was measured using B-mode ultrasound imaging. Layered, hyperplastic finite element (FE) model of the indentation measurement was created and the model response was matched with that of the stiffness meter to determine the elastic modulus were 210 kpa, respectively. Further, significance of the variations in stiffness od different tissues in the indentation response was tested.

12 Experimentally, indentation stiffness of the forearm increase during isometric extensor and flexor loads as well as under venous occlusion by 53, 91 and 15 % respectively. The FE model could reproduce the experimental responses primarily by the increased modulus of the skin; 112 % (446 kpa), 210 % (651 kpa) and 21 % (254 (kpa) under flexor and extensor loading as well as during venous occlusion respectively. The indentation response was 9-16 times more sensitive to changes in the mechanical properties of the skin than those od adipose tissue and muscle. In conclusion, the present stiffness meter may be used to quantify in vivo mechanical properties of soft tissues in the forearm, sensitively modulated by soft tissue swelling and muscle loading. 18. Influence of LymphaTouch-treatment method for pain and edema in context of active physiotherapy Airaksinen O, Vuorinen V-P, Raittila S., Internal Research Report, 2011 A pilot study that concentrates on analyzing how LymphaTouch treatment influences pain and edema in conjunction with active physiotherapy. Total of 18 patients were analyzed. For some patients over 50% pain reduction was recorded. The purpose of this study was to investigate how the introduction of a 20 minute LymphaTouch treatment to a standard active therapy session changes edema and pain. Pain was recorded with the standard VAS scale and edema with measurement bands, by palpation, and by visual observation. The study included 18 patients with neck-shoulder, knee, wrist, and elbow pain. Three wrist patients were excluded from data as their therapy did not include LymphaTouch treatment. Each patient had a doctor s referral for active physiotherapy. Research data from a total of 66 therapy sessions were analyzed for all the indications. Researched showed that already 20 minute use of LymphaTouch was effective and for some patients even 50% pain reduction was recorded. 19. Management of post-mastectomy lymphoedema by novel vacuum suction device, A case report Vuorinen V-P, Airaksinen O, Program & Abstract book. pp ISL. 22nd International Congress of Lymphology, 2009 Case study was performed on a 56-year-old female who had overcome mastectomy with lymph node evacuation. In 2002, lymphedema started to develop in patient s right arm and had progressed to stage 2. The patient has received CDT annually and wears a compression sleeve. The patient was treated with LymphaTouch. The manual part of CDT was replaced by therapy given with the LymphaTouch device, except for the handling of lymph nodes which was done manually. The patient received a series of ten treatments lasting one hour each. Arm circumference was measured before and after treatments. Whole body tissue composition was measured by InBody 720.

13 InBody measurement showed 185 ml reduction in the edematous arm and whole body fluid decreased by 900 ml (3%). Based on circumference measurement, edema reduced by 3%. The patient graded the treatment as pleasant.

14 LymphaTouch Inc. Kuortaneenkatu 2 FI Helsinki, Finland Tel Fax contact@lymphatouch.com lymphatouch.com ISO 13485:2003 certified company. LymphaTouch and PhysioTouch units are CE certified, and FDA Class 1 Exempt devices. RX Only. Copyright 2018 LymphaTouch Inc. All rights reserved v1 30/1826