Table 1.
First author (year of publication) | Country | RCT design | Aetiology, area with oedema | Definition of oedema | Sample size IG // CG | Agea in IG // CG | % men IG // CG | Intervention | Timeliness of follow-upb | Tool used to evaluate overall HRQoL | ||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Recruited | Analysed | Treatment | Duration and frequency of MLD | Additional interv.(s) | Control-group intervention(s) | |||||||||
Belmonte (2012) [26] | Spain | Cross-over | BCR, arm | Clinical diagnosis, according the ISL consensus | 19//17 | 18//14 | 70 ± 10 // 66 ± 13 |
0 // 0 | CDT | 50 min, 5x/w, 2w | CP garments, advice on skin care, exercise | Low-frequency low-intensity electrotherapy | Immediate | FACT-B + 4 |
Dayes (2013) [28] | Canada | Parallel group | BCR, arm | 10% volume difference of the limbs (affected vs. non-affected) | 57 // 46 | 56 // 39 | 61 (36–86) // 59 (41–76) |
0 // 0 | CDT | 60 min 5x/w, 4w | Elastic CP garments, advice on skin care, exercise | Elastic CP garments, advice on skin care, exercise | Immediate | |
Gradalski (2015) [29] | Poland | Parallel group | BCR, arm | Stage-II lymphoedema, according to the ISL (≥ 20% difference between limb volumes) | 30 // 30 | 25 // 26 | 61 ± 9 // 62 ± 12 |
0 // 0 | CDT | 30 min, 5x/w, 2w | CP bandaging and physical exercise | CP bandaging and physical exercise | Short-term | QoL-LQ |
Odebiyi (2014) [31] | Nigeria | Parallel group | BCR, arm | Arm-swelling without further characterisation | n.r. // n.r. | 17 // 10 | 46 ± 8 // 54 ± 14 |
0 // 0 | MLD 1 | 5 min, 2x/w, 6w | Physical exercise | Physical exercise | Intermediate | EORTC QLQ-C30 |
Ridner (2013) [32] | United States | Parallel group3 | BCR, arm | Stage I or II lymphoedema, according the ISL (1995) | n.r. // n.r | 16 // 15 | 68 ± 10 // 66 ± 11 |
0 // 0 | MLD | 40 min, n.r., mean 10 sessionsa | Low-level laser therapy | Low-level laser therapy | Immediate | ULL-27 FACT-G FACT-B |
Bongi (2011) [27] | Italy | Parallel groupc | SSc, hand | Clinical diagnosis | 20 // 20 | 20 // 15 | 57 ± 10 // 57 ± 13 |
0 // 0 | MLD | 60 min,1x/w, 5w | – | Observation | Immediate | HAQ |
Holmes (2014) [30] | United States | Parallel group | PTS, leg | Clinical diagnosis | Not specified | 15 // 16 | 47 (27–66) // 49 (22–82) |
47 // 38 | CDT | n.r, mean of 12 in 12w | Skin care, CP bandaging, physical exercise, education | CP bandaging | Immediate | VEINES-QOL |
dos Santos Crisostomo (2015) [33] | Portugal | Parallel group | VI, leg | CVI with a CEAP score of C3 to C5 | 25 // 25 | 20 // 21 | 55 ± 11 // 47 ± 11 |
25 // 5 | MLD | 45 min, 10x in 4w | Educational session | Educational session | Immediate and short-term | CIVIQ-20 |
BCR breast cancer-related, CDT complete decongestive therapy, CEAP clinical-etiologic-anatomic-pathophysiologic classification, CIVIQ-20 Chronic Venous Insufficiency Quality-of-Life Questionnaire—20 items, CG control group, CP compression, CVI chronic venous insufficiency, EORTC QLQ-C30 European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30, FACT-B, FACT-G, FACT-S functional assessment of cancer therapy(-breast)(-general)(-subscale), HAQ Health Assessment Questionnaire, IG intervention group, ISL International Society of Lymphology, MLD manual lymphatic drainage, n. r. not reported, PTS post-thrombotic syndrome, QoL-LQ Quality-of-Life Lymphoedema Questionnaire, RCT Randomised Controlled Trial, SSc systemic sclerosis, ULL-27 upper limb lymphoedema-27, VEINES-QOL Venous Insufficiency Epidemiological and Economic Study Quality-of-Life questionnaire, w weeks
aMean ± standard deviation or mean (range)
bImmediate follow-up: 1 day to 2 weeks following the last treatment; short-term follow-up: more than 2–12 weeks; intermediate- term follow-up: more than twelve weeks to 1 year; long-term follow-up: more than 1 year
cThree-arm randomised controlled trial