An N-of-1 clinical trial to assess the effectiveness of Manual Lymphatic Drainage with and without cold laser therapy for pain relief in women with lipedema.

Research question The aim of this study was to assess the efficacy of manual lymphatic drainage (MLD) with low level laser therapy (LLLT) in reducing pain compared to MLD alone in a 44-year old female patient with a medical diagnosis of bilateral lipedema. In this single-blind N-of-1 trial the participant was randomly exposed to the intervention and the comparator over time, therefore acting her own control. The trial was design in collaboration with the participant. Background info Lipedema is a disorder of adipose tissue that is characterised by hypertrophy of the lower extremities and causes pain and functional impairment. Usual treatments include manual lymphatic drainage which provides short term symptomatic relief. Participant characteristics The participant was a 44 year old female who reported heavy legs with swelling. Following ultrasound investigation her GP diagnosed ‘probable lipedema’. The patient was referred for MLD to help improve her lipedema-related pain and swelling. Key results The trend across the trial was one of decreasing pain. However, there was no discernible difference between the effects of treatment when either active or sham LLLT was applied with MLD. This trend of improvement over time was likely attributable to the combination of the MLD and the therapeutic relationship. Limitations In this study, the primary outcome measure was a measure of pain as this was identified by the patient as her most concerning symptom. This global assessment, chosen to reduce the burden on the participant, may have acted to blunt her assessment of the therapy. Szolnoky and colleagues (2011) employed a 10-item tool including descriptors of the characteristic experience of lipedema. These were: pressing, dull, heavy, pulling, torturing, enervating, violent, unbearable, exhausting, stabbing. This scale might have allowed a more nuanced and clinically useful evaluation of the two conditions. In this study the Patient Specific Functional Scale (PSFS) was used to measure the participant’s perceptions of functional limitations associated with lipedema. The validity of PSFS is influenced by the choice of functions to assess. In the context of this trial the inclusion of participation in ‘high intensity training at boot camp’ was probably inappropriate and may have compromised the validity of the PSFS. An additional week of baseline scoring would have given researchers, practitioner and participant the opportunity to refine the PSFS and improved trial protocol implementation, specifically in regard to the timely collection of study data. It may have also stabilised the daily pain scores prior to the application of the interventions.