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Trial registered on ANZCTR


Registration number
ACTRN12617001598370p
Ethics application status
Submitted, not yet approved
Date submitted
10/08/2017
Date registered
5/12/2017
Date last updated
28/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of LymphaTouch® with standard manual lymphatic drainage for secondary arm lymphoedema
Scientific title
A comparison of LymphaTouch® with standard manual lymphatic drainage for secondary arm lymphoedema
Secondary ID [1] 292632 0
None
Universal Trial Number (UTN)
U1111-1200-5603
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoedema 304359 0
Condition category
Condition code
Physical Medicine / Rehabilitation 303696 303696 0 0
Physiotherapy
Cardiovascular 304166 304166 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cancer 304167 304167 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 298865 0
Treatment: Devices
Comparator / control treatment
Manual lymphatic drainage is the version of therapist delivered massage used to drain the tissues of lymphatic fluid.
Each MLD will last approximately 60 minutes.
Control group
Active

Outcomes
Primary outcome [1] 303055 0
Assessing the effect on lymphoedema physical outcome measures that relate to fibrotic tissue induration.

This will be assessed objectively by ultrasound to achieve a measure of tissue/dermal thickness.

Ultrasound:
Assessment of tissue/dermal thickness will be conducted using ultrasound. A thick line of ultrasound gel ultrasound will be placed onto the ultrasound head, which will then be applied to the skin. The ultrasound head will be placed at set points on the arm, axilla and chest wall.
Timepoint [1] 303055 0
Baseline assessment will occur prior to randomisation.

Assessment will occur immediately after the treatment and at the post treatment assessment which occurs 24-48 hours later.
Primary outcome [2] 303977 0
Assessing the effect of treatment on patient reported outcomes including lymphoedema severity.

Overall lymphoedema severity (participant rated areas and severity) will be assessed using validated questionnaire by Norman et al 2001.
Timepoint [2] 303977 0
Baseline assessment will occur prior to randomisation.

Assessment will occur immediately after the treatment and at the post treatment assessment which occurs 24-48 hours later.
Primary outcome [3] 304042 0
Assessing the effect on lymphoedema physical outcome measures that relate to fluid in the interstitial space.

This will be measured by tape measure and bio-impedance spectroscopy.

Assessment of arm volume differences will be conducted with a narrow, non-elastic tape measure. Measurements will be taken at 10cm intervals, starting at the wrist (ulnar styloid). Hand, axilla (oblique) and mid abdomen (over umbilicus) will also be recorded. Assessment will be conducted on both arms.

Bio-impedance spectroscopy will also be recorded however the literature for BIS is validated well for the detection of early lymphoedema. Fluctuations in the reading are anticipated with changing tissue states. The readings could therefore increase when an area softens.
Timepoint [3] 304042 0
Baseline assessment will occur prior to randomisation.

Assessment will occur immediately after the treatment and at the post treatment assessment which occurs 24-48 hours later
Secondary outcome [1] 339039 0
Adverse events

This will be detected by patient report.
Timepoint [1] 339039 0
Assessment will occur immediately after treatment and at the post treatment assessment which occurs 24-48 hours later
Secondary outcome [2] 339040 0
Patient report of treatment effectiveness.

This will be recorded through VAS scales and an open ended questions to capture qualitative responses.
Timepoint [2] 339040 0
Immediately after treatment and at the follow up assessment at 24-48 hours later
Secondary outcome [3] 340601 0
Shoulder joint range of movement.

Assessment of range of motion will be conducted with the patient in seated and standing with various shoulder measures (flexion, abduction, external and internal rotation) being recorded with an inclinometer.
Timepoint [3] 340601 0
Baseline assessment will occur prior to randomisation.

Assessment will occur immediately after treatment and at the post treatment assessment which occurs 24-48 hours later

Eligibility
Key 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.

Minimum age
18 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation.
The randomisation list will be computer generated in permuted blocks of 4, 6 or 8, and a person not involved with the project will prepare sequentially numbered opaque envelopes with the group allocation sealed inside.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Group of 40 patients for a sample size of patients. The trial is a pilot design for a larger study.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
15/01/2018
Actual
Date of last participant enrolment
Anticipated
30/08/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 297263 0
University
Name [1] 297263 0
Sydney University
Country [1] 297263 0
Australia
Funding source category [2] 298003 0
Self funded/Unfunded
Name [2] 298003 0
Andrea Mangion- Masters Student
Country [2] 298003 0
Australia
Primary sponsor type
University
Name
Sydney University
Address
Sydney University
Lidcombe Campus
Faculty of Health Sciences
75 East Street
Lidcombe
NSW
2141
Country
Australia
Secondary sponsor category [1] 296236 0
Individual
Name [1] 296236 0
Andrea Mangion
Address [1] 296236 0
PO Box 23, Lindfield, NSW, 2070
Country [1] 296236 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 298380 0
HREC of the University of Sydney
Ethics committee address [1] 298380 0
Ethics and Research Integrity
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
Ethics committee country [1] 298380 0
Australia
Date submitted for ethics approval [1] 298380 0
31/08/2017
Approval date [1] 298380 0
Ethics approval number [1] 298380 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76894 0
Ms Andrea Mangion
Address 76894 0
THE UNIVERSITY OF SYDNEY
Faculty of Health Sciences
PO Box 170 (75 East St)
Lidcombe, NSW 1825 AUSTRALIA
Country 76894 0
Australia
Phone 76894 0
+61 2 9351 9021
Fax 76894 0
Email 76894 0
[email protected]
Contact person for public queries
Name 76895 0
Ms Andrea Mangion
Address 76895 0
THE UNIVERSITY OF SYDNEY
Faculty of Health Sciences
PO Box 170 (75 East St)
Lidcombe, NSW 1825 AUSTRALIA
Country 76895 0
Australia
Phone 76895 0
(61)403536416
Fax 76895 0
Email 76895 0
[email protected]
Contact person for scientific queries
Name 76896 0
Ms Andrea Mangion
Address 76896 0
THE UNIVERSITY OF SYDNEY
Faculty of Health Sciences
PO Box 170 (75 East St)
Lidcombe, NSW 1825 AUSTRALIA
Country 76896 0
Australia
Phone 76896 0
(61)403536416
Fax 76896 0
Email 76896 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.