An N-of-1 trial to assess the effectiveness of Manual Lymphatic Drainage

INTERVENTION: 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. CONDITION: Lipedema PRIMARY OUTCOME: Pain intensity using 100mm visual analogue scale (VAS) SECONDARY OUTCOME: Breakthrough analgesic medication usage General Health Questionnaire (GHQ– 12): This is a 12‐item questionnaire to assess the participant’s general health status. The participant is asked to rate each item according to a choice of four specified statements. Patient Specific Scale (PSS): Up to five daily activities that the participant identifies as being difficult or are unable to perform due to the lipedema are scored on a numerical scale from 1‐10 . Universal Pain Assessment Scale (UPAT) consisting of a numerical scale from 0 ‐ 10. 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.