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Treatment of horizontal canal BPPV-a randomized sham-controlled trial comparing two therapeutic maneuvers of
Camilla Martens1,2, Frederik Kragerud Goplen1,2, Torbjørn Aasen1
1Norwegian National Advisory Unit on Vestibular Disorders, Department of Otorhinolaryngology & Head Neck Surgery Haukeland University Hospital Bergen Norway.
Objectives:
To compare the effect of a high-speed barbecue maneuver with the modified Lempert maneuver and sham in patients with benign paroxysmal positional vertigo (BPPV) of the horizontal canal.
Methods:
Randomized sham-controlled, single blinded multicenter clinical trial in two university hospitals investigating consecutive patients with horizontal canal BPPV.Patients were randomly assigned to high-speed barbecue (HSB), modified Lempert maneuver (ML), or sham maneuver (SM). All treatments were performed in a biaxial rotational chair with weekly follow-up to a maximum of three treatment sessions. The final follow-up was 3 months after the last treatment.
Results:
Primary outcome: 2-week recovery rate per protocol. Secondary outcome: Cumulative recovery rate and Dizziness Handicap Inventory (DHI) scores after 3 months per protocol (HSB and ML) and intention to treat (all groups).Fifty-four patients were analyzed after 2 weeks (HSB = 17; ML = 20; SM = 17). Two-week recovery rate was 14/17 after HSB, 11/20 after ML, and 4/17 after SM, with significantly better recovery in HSB [OR 15.17, 95% CI (1.85, 124.63), P = .001] using sham as base level. Recovery rate after 3 months was 15/17 after HSB and 15/19 after ML. Cumulative recovery rate showed no significant differences between the two treatment groups [95% CI (0.30, 13.14), P = .46] in cure rate DHI [95% CI (-16.56, 15.02), P = .92]. No unexpected adverse events were observed.
Conclusion:
Velocity change in horizontal canal BPPV treatment gives a faster initial recovery. Rapid recovery could reduce the disease burden.
Trial Registration:
Clinicaltrials.gov. Identifier: NCT01905800.
Level Of Evidence:
1b.
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