Methods | Randomised controlled trial (non‐blinded) | |
Participants | 120 patients in total (66 female, 54 male). The control group's mean age was 48 years (range 24 to 82), the intervention group had a mean age of 49 (range 23 to 78) The initial assessment was at 5 days, with follow‐up period ranging from 6 to 20 months 3 patients in the control group were found to be subconsciously performing postural restrictions and were excluded from the study analysis The mean duration of the symptoms of vertigo was 30.1 days (range 1 to 200) in the control group and 28.4 days (range 1 to 300) in the intervention group The inclusion criteria were a positive Dix‐Hallpike test assessed using Frenzel glasses and symptoms of vertigo. Patients with unilateral, bilateral posterior canal BPPV and posterolateral BPPV were included. 8 patients in total had BPPV without nystagmus and were followed up in a separate group. There is no information regarding exclusion criteria |
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Interventions | All patients had the standard single Epley manoeuvre performed without premedication The control group had no other instructions or intervention, and were encouraged to perform all kinds of movements The experimental group had post‐manoeuvre instructions to wear a cervical collar for 48 hours, to use 2 to 3 pillows at night for 48 hours and to refrain from turning to the affected ear |
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Outcomes | PRIMARY OUTCOMES: Objective: Dix‐Hallpike negative |
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Notes | Patients in the control group who on questioning had subconsciously refrained from turning to the affected side during sleep, performed head elevation, avoided sudden head movements or refrained from normal daily activities were excluded (n = 3) All the patients that needed a third Epley manoeuvre in the control group were prescribed postural restrictions (n = 6). This could confound the data 8 patients with vertigo symptoms, but without nystagmus were included in the trial; 3 in the intervention group and 5 in the control ‐ this could introduce the possibility of selection bias |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Unclear (the authors have been contacted) |
Allocation concealment (selection bias) | High risk | Unclear (the authors have been contacted) 8 patients with vertigo symptoms, but without nystagmus were included in the trial; 3 in the intervention group and 5 in the control ‐ this could introduce the possibility of selection bias. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Unclear (the authors have been contacted) ‐ assumed non‐blinded as not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No patients were lost to follow‐up |
Selective reporting (reporting bias) | Low risk | |
Other bias | High risk | All the patients that needed a third Epley manoeuvre in the control group were prescribed postural restrictions (n = 6); this could confound the data Additionally no information was provided regarding exclusion criteria |