The National Lipedema Study

St. Olavs Hospital, University Hospital of North Norway, Sykehuset Telemark, University of Bergen, Klinbeforsk, Helse Vest

Lipedema is a chronic condition with a symmetrical accumulation of painful fatty tissue primarily affecting the limbs, sparing hands, feet and trunk. The subcutaneous fatty tissue is disproportionately voluminous and may have a different microstructure and metabolism than the patient's regular fatty tissue. The condition affects almost exclusively women and usually debuts around puberty. Lipedema seems to have a hereditary component, may be affected by hormonal variations and worsens with obesity. Guidelines advocate conservative treatment with compression therapy, weight management, physical activity, life style changes and psychological support;and in some cases surgical treatment such as bariatric surgery and liposuction. Treatment of lipedema is indicated when the condition causes significant pain and inhibits the patient's everyday activities. Well-designed randomized controlled studies on lipedema are lacking. The Ministry of Health and Care Services in Norway has found the scientific documentation for the effects of liposuction to be insufficient and has recommended that surgical treatment of lipedema should be evaluated through a 5-year clinical trial. A national task force, consisting of representatives from all four regional health authorities in Norway has been set up. This task force has now initiated this study. A national multi-center study with homogenous treatment protocols can provide globally sought insight on lipedemaand the effect of its treatment regimes, and the findings will be important to adjust future treatment strategies regarding both effect and cost/effectiveness.

Liposuction, Conservative treatment, Intermittent pneumatic compression, Lipoedema, Compression therapy, Self management, Dietary management

Eligible patients are randomized to two different conservative treatment protocols;either standard conservative treatment (SCT) or standard treatment plus additional lymphedema treatment (intermittent pneumatic compression -IPC). After 6 months the effects of the conservative treatment areevaluated. Patients who still want surgery and fulfill the criteria are randomized (1:1) to early (cases(liposuction initiated 6-9 months after inclusion)) or late surgery (controls (liposuction initiated 18-21 months after inclusion)). Randomization to the surgical group is stratified by conservative treatment arm.

Standard Conservative treatment consisiting of: Physical therapy, includng Compression garment and exercise program Self-care program Individual counseling from a clinical dietician

Standard Conservative treatment consisiting of: Physical therapy, includng Compression garment and exercise program Self-care program Individual counseling from a clinical dietician Additional lymphedema treatment consising of intermittent pneumatic compression (IPC)

Late liposuction, 18-21 months after inclusion. This group functions as a control group for 1 year before enrolment in the Liposuction group.

Standard Conservative treatment consisiting of: Physical therapy, including compression garment and exercise program, Self-care program

Physical therapy, including compression garment and exercise program, Self-care program and Intermittent Pneumatic Compression (IPC)

Effect of different conservative treatments on lipedema pain and quality of life and everyday activites for patients with lipedema

Inclusion Criteria: female age 20-65 years significant pain from lipedema lipedema stage 1-2 or localized stage 3 Exclusion Criteria: Non-fluency in the Norwegian language pregnancy current malignancy previous surgical treatment for lipedema smoking BMI > 28 serious comorbidities such as cardiac-, pulmonary-, renal disease unwillingness to wear compression garments