None listed
Conditions
Brief summary
The project aims to assess whether manual lymphatic drainage (MLD) with non-thermal laser is more effective than MLD alone for reducing pain and swelling in a 43-year old female patient with bilateral lipedema-like symptoms of the legs. The trial is designed as a single-blind, randomised, controlled n-of-1 trial. The trial participant will attend weekly clinic sessions for eight weeks. Weeks 1 and 8 will be assessment sessions. Weeks 2-7 are treatment clinics where the participant will receive either manual lymphatic drainage massage (MLD) plus active laser therapy or MLD plus placebo laser therapy in a randomised sequence. The placebo therapy consists of the laser device without power.
Interventions
Manual lymphatic drainage massage is a light but very specific massage therapy designed to reduce lymph swelling by stimulating lymphatic drainage. The therapist, Angela Balinski, is trained in the anatomy and physiology of the lymphatic system and the safe use of MLD to facilitate lymph drainage of the vessels.
The non-thermal laser treatment is used to treat acute and chronic pain, and to relieve swelling and inflammation, all symptoms associated with lipedema and lymphoedema. The laser is ap
Manual lymphatic drainage massage is a light but very specific massage therapy designed to reduce lymph swelling by stimulating lymphatic drainage. The therapist, Angela Balinski, is trained in the anatomy and physiology of the lymphatic system and the safe use of MLD to facilitate lymph drainage of the vessels. The non-thermal laser treatment is used to treat acute and chronic pain, and to relieve swelling and inflammation, all symptoms associated with lipedema and lymphoedema. The laser is applied to the hard, painful areas of the affected limb to increase the softness of the tissue, thereby increasing the amount of fluid that can move out of tissue. Again, the therapist is trained in the application of the laser device. The low-level laser device to be used in this study (model LTU-904; Serial Number L20541) is manufactured by Riancorp Pty Ltd, Henley beach South Australia. It is approved for use by the Therapeutic Goods Administration (AUST R 163516) as a class 11a medical device. The device is a portable rechargeable battery powered unit. It emits a 904-nanometer beam. The average output is 5 milliwatts. The laser goes to a 2 cm depth and 2 cm width. Points of pain or fibrosis or scarring are treated by applying the beam for one minute per point. The trial is designed as a single-blind, randomised, controlled n-of-1 trial. The trial participant will attend weekly clinic sessions for eight weeks. Weeks 1 and 8 will be assessment sessions. Weeks 2-7 are one hour treatment clinics where the participant will receive either manual lymphatic drainage massage (MLD) for 30 minutes plus active laser therapy for 10 minutes or MLD (30 minutes) plus placebo laser therapy (10 minutes). The six treatment sessions are divided into 3 active laser sessions and 3 placebo laser sessions according to the randomisation plan prepared by an independent statistician. All laser sessions (both active and placebo) are accompanied by MLD treatment. Each weekly clinic session will be separated by a one-week washout. One participant will be recruited from the body of patients in Ms Angela Balinski’s complementary medicine practice. All clinic sessions will be conducted at Ms Balinski's practice premises.
Sponsors
Associate Professor Sandra Grace
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Female; aged between 18 and 85 years; participants of childbearing age who agree to continue using birth control measures for the duration of the study; pain associated with swelling in at least one limb; diagnosis of lipedema.
Exclusion criteria
Cancer; cardiac disease; kidney disease; epilepsy; participants who are lactating, pregnant or planning to become pregnant; participants unwilling to comply with the study protocol; any other condition, which in the opinion of the investigators could compromise the study
Outcome results
None listed