An N-of-1 trial to assess the effectiveness of Manual Lymphatic Drainage with and without Non-thermal Laser in lipedema.

Not Applicable

Completed

• Conditions: ipedema; Lipedema; Alternative and Complementary Medicine - Other alternative and complementary medicine; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12617001522303
• Lead Sponsor: Associate Professor Sandra Grace

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-01
• Study Completion: 2017-12-22
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity using 100mm visual analogue scale (VAS)[Pain intensity will be measured at the same time on a daily basis for the eight weeks of the trial. Each of these 56 time points are considered primary time points as the data will be plotted on a time series graph to enable correlation with the treatment phases and washout phases of the trial. ]