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. 2017 Sep 26;2017(9):CD004174. doi: 10.1002/14651858.CD004174.pub3

Ginsberg 2001.

Methods Study design: randomised double‐blind clinical trial
Method of randomisation: prerandomisation stratification applied, randomisation not stated
Concealment of allocation: not stated
Blinding: observer and outcome assessor blinded
Follow‐up: mean 4.6 to 4.9 years
Losses to follow‐up: not reported, but 3 participants in the treatment group died (none in the control group)
Participants Country: Ontario, Canada
No. of participants: 47
Age: mean age 61 years
Sex: males 26; females 21
Inclusion criteria: asymptomatic postphlebitic syndrome and venous valvular incompetence (as assessed by photoplethysmography or venous Doppler)
Exclusion criteria: previous graduated compression stocking therapy, geographic inaccessibility, and failure to provide informed consent
Interventions Intervention group (n = 24): elastic compression stockings; below‐knee elastic compression stockings with ankle pressure of 20 to 30 mmHg at the ankle region
Control (n = 23): placebo stocking
Start of compression stockings: 1 year after DVT diagnosis
Outcomes Cumulative incidence of PTS
Notes Three‐part study; only data from study 2 are taken into account
Study was terminated after an interim analysis owing to slow recruitment of patients.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No description of random sequence generation
Allocation concealment (selection bias) Unclear risk No description of allocation concealment
Blinding (performance bias and detection bias) 
 Objective outcome(s) Low risk Participants and outcome assessors were blinded. For participants, placebo stockings were provided. Participants were informed not to wear stockings to the assessments.
Blinding (performance bias and detection bias) 
 Subjective outcome(s) Low risk Participants and outcome assessors were blinded. For participants, placebo stockings were provided. Participants were informed not to wear stockings to the assessments.
The definition of PTS contained both objective and subjective items.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Incomplete outcome data are not described, but 3 participants (in the active stocking group) died.
Selective reporting (reporting bias) Low risk Only PTS was a prespecified outcome; this is reported.
Other bias Low risk Study seems to be free of other risk of bias.