AbstractObjective Observational trials have suggested that Intermittent Pneumatic Compression (IPC) devices reduce lymphedema (LED) volume and improve patient reported outcomes (PROS), but this type of trial is subject to bias. Systematic reviews (SRs) of randomized controlled trials (RCTs) provide the highest evidentiary strength for examining the impact of a therapeutic intervention and are important for evidence-based Clinical Practice Guidelines. Few existing SRs, however, include recent RCTs and only a smaller number address LED of the lower extremities (LELED). Therefore, we conducted a SR based on PICO questions to identify RCT's, which examine the effect of IPC on lower extremity lymphedema (LELED) for a Clinical Practice Guideline. Methods For this SR English language RCTs in CINAHL®, Embase®, and MEDLINE® published between January 1, 2010, to January 31, 2025, were searched and the PRISMA reporting method was employed. Both intra and inter group comparisons of the specified outcome measures were examined for statistical significance. The evidentiary quality of the RCTs and risk of bias were assessed using GRADE and the Cochrane risk of bias tool (RoB 1) respectively. Results In the PRISMA analysis 141 articles were identified through a search of the databases and an additional four articles were discovered through other sources for a total of 145 eligible RCTs. Twenty-one RCTs addressed upper extremity LED and seven LELED RCTs met the criteria for inclusion: adults ≥18 years with unilateral or bilateral chronic lower-extremity lymphedema and present for ≥6 months and in the maintenance phase of treatment. The patient must have an ankle brachial index (ABI) ≥0.8; no active infection or acute venous thrombosis; able to use the study device and comply with daily therapy. The average total number of patients per RCT was 54, while the mean age was 55 years. Female gender predominated (67%). The majority of RCTs were composed of secondary LED, but three series included a segment of primary LED. Chronic venous insufficiency was the most common etiology in the seven RCT's. Five RCTs had two arms, while two had three arms. The experimental arm employed an advanced pneumatic compression device (APCD) in five RCTs, but complex decongestive therapy (CDT) was combined in this arm with IPC in three. The control comparator arm was CDT in three, a simple IPC in one and an APCD using a different mode in another. Circumferential measurement of limb girth by tape was the most common method to determine volume changes. Five of seven RCTs used a daily treatment regimen with four employing twice daily sessions. Study length varied with four weeks in three, five weeks in one and eight months in another. An a priori power calculation was carried out in 3/7 RCTs. Reduced limb volume was the outcome measure employed in all 7 studies and all 7 showed statistically significant reductions in limb volume when comparing baseline values to end of treatment values. Five RCTs also demonstrated differences in their intergroup comparisons of edema reduction. Patient reported outcomes in 5 RCTs with three generic QoL (SF-36, VAS, EQ5D3L) and two disease-specific (Lymph ICF-LL, LYMQOL) QoL measures demonstrated significant improvements by intragroup comparison in three RCTs. Heterogeneity and the composition of the experimental and control groups, however, prevented meta-analysis. The methodological quality of the 7 RCTs included in this review was evaluated using the Cochrane Risk of Bias Tool (RoB 1). Overall, the included studies demonstrated moderate methodological quality. Assessment of these RCTs by GRADE showed moderate certainty that IPC reduces lower-limb edema, volume, or circumference compared with standard care or no IPC. Conclusion Despite combining ("bundling") additional treatment with IPC in three studies, intragroup comparison demonstrated highly significant reductions in limb volumes with IPC in all RCTs and in 5/7 RCTs by intergroup comparison. Quality indicators demonstrated a moderate risk of bias and moderate certainty.
O’Donnell et al. (Wed,) studied this question.