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A comparison of LymphaTouch® with standard manual lymphatic drainage for secondary arm lymphoedema

A comparison of LymphaTouch® with standard manual lymphatic drainage for secondary arm lymphoedema

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001598370
Enrollment
40
Registered
2017-12-05
Start date
2018-01-15
Completion date
2018-08-30
Last updated
2018-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to determine if a single session of LymphaTouch® treatment is as effective, than standard manual lymphatic drainage (MLD) in improving lymphoedema outcomes. Who is it for? You may be eligible to join this study if you are a female aged 18-75 years and have secondary arm lymphoedema in one arm only following axillary node dissection from either breast cancer or melanoma of between 6 months and 5 years duration. Study details Study participants will be assigned on a 'chance' basis to receive standard care or an intervention. Those allocated to standard care will receive one session of manual lymphatic drainage. Intervention group participants will be treated with LymphaTouch device during one session. LymphaTouch uses negative pressure, medical technology designed to lift tissues upwards through a vacuum force. Before treatment, immediately after completion of treatment and 24-48 hours later, tissue softness, patient reported outcomes and participant’s satisfaction with treatment will be measured. It is hoped that this study will determine if LymphaTouch® treatment is as effective, than standard manual lymphatic drainage (MLD) in improving lymphoedema outcomes.

Interventions

The aim of this project is to determine if a single session of LymphaTouch® treatment is as effective, than standard manual lymphatic drainage (MLD) in improving lymphoedema outcomes, such as limb size and tissue softness as well as participant satisfaction with the treatment. Brief description of LymphaTouch: LymphaTouch, also known as PhysioTouch, is a hand-held massage device that uses negative pressure for lymphatic drainage. Being created in 2009 in Finland, the mechanism of action is opp

The aim of this project is to determine if a single session of LymphaTouch® treatment is as effective, than standard manual lymphatic drainage (MLD) in improving lymphoedema outcomes, such as limb size and tissue softness as well as participant satisfaction with the treatment. Brief description of LymphaTouch: LymphaTouch, also known as PhysioTouch, is a hand-held massage device that uses negative pressure for lymphatic drainage. Being created in 2009 in Finland, the mechanism of action is opposite to MLD as rather than a positive or pushing force being applied to the tissues, a negative force or lifting force, is applied to the tissues. By creating changes in local tissue pressure lymphatic vessels it is theorised that local lymphatic vessels can be opened with improved flow rates. Case studies and small case series on patients with lymphoedema have shown positive treatment outcomes in patients with lymphoedema. Negative pressure technology is well documented in chronic wound management. Apart from vacuum assisted closure of the wounds, tissue healing has been shown to be promoted through controlling inflammation and improving the inflammatory properties of the tissues. This is relevant in lymphoedema considering that tissue inflammation in lymphoedema contributes to fibrosis, fat deposition and cellulitis risk. Brief description of MLD: MLD uses a series of manual massage techniques that involve light strokes designed to move fluid through the superficial lymphatic capillary network. A “central reservoir” is created by clearing areas that are further most away from the congestion before working on areas of congestion. Who will deliver the treatment intervention: Treatments will occur immediately after randomisation and last for approximately 30 to 60 minutes, depending on group allocation. The LymphaTouch treatment will be completed by one RA, an experienced Lymphoedema Physiotherapist trained in Finland on the LymphaTouch technique. The MLD will be performed by a RA trained in MLD technique. Both RA will base the treatment on standard clinical protocols. For LymphaTouch, the manufacturing company, HLD, has provided a drainage protocol for arm drainage, fibrosis and scars treatment. Setting parameters are defined in this guideline. Treatment titration: As part of the assessment the participant elects areas of the arm or trunk that feel most firm and/or swollen. Within the given treatment time allocation, the RA may elect to focus more time on this area, as fitting within the standard setting parameters of the treatment protocols. If any pain or discomfort is reported by the participant, the LymphaTouch dosage will be reduced until pain or discomfort is no longer experienced. If this occurs, this is to be documented as part of this participant’s treatment record. Intervention adherence: No additional adherence required. Participants will return 24 to 48 hours later to undergo follow-up assessments by a RA blinded to treatment group. The participant self reports whether they abided by their "usual lymphoedema management regime" following the treatment.

Sponsors

Sydney University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Female participants will have secondary arm lymphoedema in one arm only following axillary node dissection from either breast cancer or melanoma of between 6 months and 5 years duration and clinically detectable lymphoedema are eligible to participate.

Exclusion criteria

Participants will be excluded if they are under 18 years and aged greater than 75 years, if there is the presence of lymphoedema in both arms, a pacemaker or other in-dwelling stimulation device or pregnancy (due to the bio-impedance measurement), the inability to independently mobilise to the University of Sydney Lidcombe campus, and weight over 120kg. Sensitivity to light touch, significant risk of bruising, active infective cellulitis and active cancer treatment would also exclude participation.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026