title: Graduated compression stockings to treat acute leg pain associated with proximal DVT. A randomised controlled trial.
abstract: Acute deep venous thrombosis (DVT) causes leg pain. Elastic compression stockings (ECS) have potential to relieve DVT-related leg pain by diminishing the diameter of distended veins and increasing venous blood flow. It was our objective to determine whether ECS reduce leg pain in patients with acute DVT. We performed a secondary analysis of the SOX Trial, a multicentre randomised placebo controlled trial of active ECS versus placebo ECS to prevent the post-thrombotic syndrome.The study was performed in 24 hospital centres in Canada and the U.S. and included 803 patients with a first episode of acute proximal DVT. Patients were randomised to receive active ECS (knee length, 30-40 mm Hg graduated pressure) or placebo ECS (manufactured to look identical to active ECS, but lacking therapeutic compression). Study outcome was leg pain severity assessed on an 11-point numerical pain rating scale (0, no pain; 10, worst possible pain) at baseline, 14, 30 and 60 days after randomisation. Mean age was 55 years and 60% were male. In active ECS patients (n=409), mean (SD) pain severity at baseline and at 60 days were 5.18 (3.29) and 1.39 (2.19), respectively, and in placebo ECS patients (n=394) were 5.38 (3.29) and 1.13 (1.86), respectively. There were no significant differences in pain scores between groups at any assessment point, and no evidence for subgroup interaction by age, sex or anatomical extent of DVT. Results were similar in an analysis restricted to patients who reported wearing stockings every day. In conclusion, ECS do not reduce leg pain in patients with acute proximal DVT.
authors.affiliation: Susan R. Kahn, MD MSc, Centre for Clinical Epidemiology, Jewish General Hospital, 3755 Cote Ste. Catherine, Room H420.1, Montreal, QCH3T1E2, Canada, E-mail: susan.kahn@mcgill.ca.
authors.forename: S R
authors.initials: SR
authors.lastname: Kahn
authors.forename: S
authors.initials: S
authors.lastname: Shapiro
authors.forename: T
authors.initials: T
authors.lastname: Ducruet
authors.forename: P S
authors.initials: PS
authors.lastname: Wells
authors.forename: M A
authors.initials: MA
authors.lastname: Rodger
authors.forename: M J
authors.initials: MJ
authors.lastname: Kovacs
authors.forename: D
authors.initials: D
authors.lastname: Anderson
authors.forename: V
authors.initials: V
authors.lastname: Tagalakis
authors.forename: D R
authors.initials: DR
authors.lastname: Morrison
authors.forename: S
authors.initials: S
authors.lastname: Solymoss
authors.forename: M-J
authors.initials: MJ
authors.lastname: Miron
authors.forename: E
authors.initials: E
authors.lastname: Yeo
authors.forename: R
authors.initials: R
authors.lastname: Smith
authors.forename: S
authors.initials: S
authors.lastname: Schulman
authors.forename: J
authors.initials: J
authors.lastname: Kassis
authors.forename: C
authors.initials: C
authors.lastname: Kearon
authors.forename: I
authors.initials: I
authors.lastname: Chagnon
authors.forename: T
authors.initials: T
authors.lastname: Wong
authors.forename: C
authors.initials: C
authors.lastname: Demers
authors.forename: R
authors.initials: R
authors.lastname: Hanmiah
authors.forename: S
authors.initials: S
authors.lastname: Kaatz
authors.forename: R
authors.initials: R
authors.lastname: Selby
authors.forename: S
authors.initials: S
authors.lastname: Rathbun
authors.forename: S
authors.initials: S
authors.lastname: Desmarais
authors.forename: L
authors.initials: L
authors.lastname: Opatrny
authors.forename: T L
authors.initials: TL
authors.lastname: Ortel
authors.forename: J-P
authors.initials: JP
authors.lastname: Galanaud
authors.forename: J S
authors.initials: JS
authors.lastname: Ginsberg
mesh_terms: D059787:Acute Pain / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D000328:Adult; D000368:Aged; D002170:Canada; D004867:Equipment Design; D005260:Female; D006801:Humans; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D054070:Postthrombotic Syndrome / Q000209:etiology / Q000517:prevention & control; D012720:Severity of Illness Index; D053828:Stockings, Compression; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D020246:Venous Thrombosis / Q000150:complications / Q000175:diagnosis / Q000628:therapy*
keywords: Randomised controlled trial; compression; pain; placebos; stockings; therapeutics; venous thrombosis