Boehler 2014.
Methods | Prospective, single‐centre, open‐label, randomised study. | |
Participants | 73 outpatients with isolated superficial vein thrombosis of the legs. Thrombus length ≥ 5 cm and confirmed by compression ultrasonography. Mean age 56.3 years (SD 13.2) in compression stockings group and 60.3 years (SD 14.8) in control group. | |
Interventions | Thigh‐length compression stockings, class II (23‐32 mmHg; Venotrain, Bauerfeind, Zeulenroda, Germany) for 3 weeks. No compression. |
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Outcomes | Primary outcome: reduction of spontaneous and induced pain as assessed by a VAS and Lowenberg test. Secondary outcomes: consumption of analgesics, thrombus length, skin erythema, D‐dimer, and quality of life through the SF‐36. Main safety outcomes: symptomatic or asymptomatic DVT and HIT. |
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Notes | All participants received LMWH at prophylactic dosage (enoxaparin 40 mg/day). NSAIDs (mefenamic acid, diclofenac, and dexibuprofen) were allowed. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of sequence generation not reported. "The randomization procedure was performed in a 1:1 ratio in blocks of 20 with closed envelopes." |
Allocation concealment (selection bias) | Unclear risk | Unclear if envelopes were sealed and sequentially numbered. "The randomization procedure was performed in a 1:1 ratio in blocks of 20 with closed envelopes, with the investigators not being aware of the sequence within the envelopes." |
Blinding (performance bias and detection bias) All outcomes | High risk | Open study. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 7/80 (8.7%) participants initially enrolled were excluded from the analysis due to missing data during follow‐up. |
Selective reporting (reporting bias) | Low risk | All outcomes described in methods section were reported in results section of the study publication. |