Clinically meaningful symptom improvements associated with a cooling intervention for chronic venous disease

Background: Chronic venous disease (CVeD) is a disorder of the lower extremity venous system characterized by numerous burdensome symptoms for which few targeted interventions exist.

Purpose: Test a cooling intervention compared to placebo on symptom improvements.

Methods: Randomized single blinded 6-month clinical trial of 276 persons allocated to 3 times weekly cooling or placebo cuff applied to the most severely affected leg during 30 minutes of leg elevation. Eleven symptoms were measured at baseline and end-of-study with the VEINES QOL/Sym questionnaire to determine clinically relevant symptom changes. Data were analyzed for a 30% moderate improvement and symptom severity based on cut-points calculated from ±1 standard error of measurement, reported by group, sex and age.

Results: Moderate improvements were noted for the cooling group compared to placebo for cramps (40%; 28%), irritability (32%; 27%) and throbbing (30%;19%) – both groups had improvements in pain (53%; 59%) and swelling (46%; 40%). Females had greater improvements than males in burning (33%; 21%) and irritability (33%; 26%) - both sexes had improvement in cramps (36%; 33%), pain (59%; 53%) and swelling (44%; 43%).  Individuals < 65 compared to >/= 65 years of age had improvements in cramps (39%; 27%) and irritability (36%; 21%) -  both groups had improvements in pain (56%; 57%) and swelling (46%; 40%). For cut-points, more females experienced a statistically significant improvement for itch (24.1% vs. 17.1%, p=0.028). Participants < 65 were significantly less irritable (36.4% vs 21.2%, p=0.021). Though not statistically significant, differences were observed in younger participants who experienced less leg restlessness (25.4% vs. 11.8%, p=0.054).

Conclusions: Clinicians caring for individuals with CVeD should consider recommending a cooling with leg elevation protocol to improve symptoms especially pain, swelling and irritability. Sex and age are important considerations as differences were noted in symptom improvements such as burning and cramps.