None listed
Conditions
Brief summary
This study aims to determined if a 3 week treatment using the Niagara® Cycloid® massage pad has an impact on chronic unilateral chronic oedema/lymphoedema of the legs arising because of treatment for cancer. Who is it for? You may be eligible for this study if you a patient clinically diagnosed with chronic oedema/lymphoedema (arising from treatment for cancer) of one leg, more than 1.5 years duration but less than 10 years, either Overweight or moderately obese. Study details Participants who meet the eligibility criteria in this study will be randomly selected to be part of one of two treatment groups: Group 1: participants will continue with their usual treatment for their oedema/lymphoedema, or Group 2: participants will use the massage pad for 3 weeks at home. Participants will then be followed up at 7 timepoints via ultrasound, questionnaire and other assessments for up to 1 month after completion of the 3 week intervention period. It is hoped that this treatment will primarily help reduce fluids in the affected leg, resulting in reduced pain and tension and heaviness as well as making the limb smaller.
Interventions
Only patients enrolled in the study will receive access to the massage pad. All participants must use the massage pad according to a defined regimen, as outlined below.
1.Pad on abdominal area (or lower back) – Patient lying face up.
2.Pad under posterior thighs – Patient lying face up.
3.Pad on top of anterior thigh – Patient lying face up.
4.Pad under lower leg (ankle to calf area) – Patient lying face up.
This regimen was designed to simulate the sequence used during a lymphoedema drainage m
Only patients enrolled in the study will receive access to the massage pad. All participants must use the massage pad according to a defined regimen, as outlined below. 1.Pad on abdominal area (or lower back) – Patient lying face up. 2.Pad under posterior thighs – Patient lying face up. 3.Pad on top of anterior thigh – Patient lying face up. 4.Pad under lower leg (ankle to calf area) – Patient lying face up. This regimen was designed to simulate the sequence used during a lymphoedema drainage massage such as manual lymphatic drainage (although it is acknowledged that the exact nature cannot be mimicked). The aim being to clear lymph nodes and vessels in the abdomen and lower back before working downward and clearing vessels in the thighs and calves. Each placement period is 10 mins. Other key information: who will deliver the regimen: Participants under the supervision initially of the researchers to check they do it properly. Only one procedure and that is delivery of massage using massage pad for a total of 30 mins. The regimen will be delivered daily over 3 weeks. The regimen will occur at the patients residence. Strategies used to assess monitor adherence or fidelity to the defined regimen, include: Telephone or computer video checks (depending on what the participant has access to initially) and then diary. Normal routine will continue in addition to the regime. That is skin care, manual lymphatic drainage, diaphragmatic breathing, compression.
Sponsors
Niagara Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Clinically diagnosed Chronic oedema/lymphoedema (arising from treatment for cancer) of one leg, more than 1.5 years duration but less than 10 years duration. BMI classes: Overweight 25- 30 and Obese Class I (Moderately obese)31-35.
Exclusion criteria
No clinically diagnosed thyroid disorder (nor medications for it) No venous issues of the legs including venous reflux, significant varicosities or signs of venous disorder/disease (LDS, Haemosiderin in over large areas) Spider veins and minor superficial venous telangiectasia ok) No leg swelling prior to the intervention for cancer (statement from the referring clinician about this) No medications likely to have an influence on sodium retention such as Beta blockers, Diuretics. No current wounds/ulcers on the legs No signs of significant recent soft tissue wounding No signs of current skin breakdown. Normal liver, renal and heart function No Current or recent (< 1 month) bacterial infections (Cellulitis)
Outcome results
None listed