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A randomised controlled trial of neuromuscular stimulation in non-operative venous disease improves clinical and symptomatic status |
Ravikumar R, Lane TRA, Babber A, Onida S, Davies AH |
Phlebology 2021 May;36(4):290-302 |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
BACKGROUND: This randomised controlled trial investigates the dosing effect of neuromuscular electrical stimulation (NMES) in patients with chronic venous disease (CVD). METHODS: Seventy-six patients with CEAP C3 to C5 were randomised to group A (no NMES), B (30 minutes of NMES daily) or C (60 minutes of NMES daily). Primary outcome was percentage change in Femoral Vein Time Averaged Mean Velocity (TAMV) at 6 weeks. Clinical severity scores, disease-specific and generic quality of life (QoL) were assessed. RESULTS: Seventy-six patients were recruited -- mean age 60.8 (SD 14.4) and 47:29 male. Six patients lost to follow-up. Percentage change in TAMV (p < 0.001) was significantly increased in groups B and C. Aberdeen Varicose Veins Questionnaire Score (-6.9, p = 0.029) and Venous Clinical Severity Score (-4, p-0.003) improved in group C, and worsened in group A (+1, p = 0.025). CONCLUSIONS: Daily NMES usage increases flow parameters, with twice daily usage improving QoL and clinical severity at 6 weeks in CVD patients.
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