Effect of Self-treatment of Recurrent Benign Paroxysmal Positional Vertigo

This randomized clinical trial assesses the efficacy of a web-based diagnosis and treatment of benign paroxysmal positional vertigo when it recurs in patients with confirmed and treated benign paroxysmal positional vertigo.

Key Points

Question

Are web-guided diagnosis and treatment feasible and effective in recurrent benign paroxysmal positional vertigo (BPPV)?

Findings

In this randomized clinical trial of 585 patients, patients in the treatment group, who performed the canalith repositioning maneuver according to web-based diagnosis of BPPV subtype, showed a higher proportion of vertigo resolution than controls, who applied the canalith repositioning maneuver based on the subtype of BPPV during the previous attack (72.4% vs 42.9%).

Meaning

Patients may benefit from treating BPPV themselves using a web-guided system.

Abstract

Importance

Benign paroxysmal positional vertigo (BPPV) is the most common cause of vertigo with frequent recurrences.

Objective

To determine the efficacy of a web-based diagnosis and treatment of BPPV when it recurs in patients with confirmed and treated BPPV.

Design, Setting, and Participants

This randomized, controlled, parallel-group, double-blind trial took place in multiple referral-based university hospitals in South Korea between July 2017 and February 2020. Of 728 patients (age ≥20 years) with diagnosed and treated BPPV, 585 were enrolled after excluding 143 who declined participation, could not use the internet, or had spinal problems, multicanal BPPV, or cognitive dysfunction. Patients were followed up for recurrence at least for 2 years until February 2022.

Interventions

Patients were randomly assigned (1:1) to the treatment or control group. The patients in the treatment group completed a questionnaire for diagnosis and received a video clip for self-administration of canalith repositioning maneuver (CRM) according to the type of BPPV diagnosed when they experienced positional vertigo again. Patients in the control group received a video clip for self-administration of CRM according to the type of BPPV that had been diagnosed on enrollment.

Main Outcomes and Measures

The primary outcome was self-reported resolution of positional vertigo post-CRM. Secondary outcomes included difficulties and requirement for assistance when using the program and any falls or other adverse events related to CRM. The primary outcome was analyzed using both intention-to-treat and per-protocol methods.

Results

Of 585 patients enrolled, 292 were randomized to the treatment group (mean [SD] age, 60.3 [12.8] years, 37 [64%] women) and 293 were randomized to the control group (mean [SD] age, 61.1 [13.2] years; 50 [71%] women). Overall, 128 (21.9%) had recurrence (58 in the treatment group and 70 in the control group), and 109 (85.2%) successfully used the web-based system. In the intention-to-treat analysis, 42 of 58 individuals (72.4%) in the treatment group and 30 of 70 individuals (42.9%) in the control group reported vertigo resolution (χ² test: 95% CI, 0.13-0.46; P < .001).

Conclusions and Relevance

This trial proved the efficacy of a web-based system for the diagnosis and treatment of recurrent BPPV. Use of this system may play an important role in telemedicine for vestibular disorders.

Trial Registration

Clinical Research Information Service Identifier: KCT0002364

Introduction

Dizziness/vertigo is the third most common symptom prompting emergency department visits,¹ accounting for 3.5% to 11% of total emergency department visits,^2,3 with an annual cost estimated at $3.9 million in the US in 2011.⁴ Benign paroxysmal positional vertigo (BPPV), the most common cause of vertigo, is found in approximately 17% to 42% of patients with vertigo.^5,6 BPPV is believed to be caused by dislodged otoconia that enter the semicircular canals.⁷ In response to a change in the static orientation of the head with respect to gravity, the otolithic debris moves to a new position within the semicircular canals, leading to a false sense of rotation.⁸ The canalith repositioning maneuver (CRM) can effectively treat BPPV.^9,10,11,12 CRM results in immediate resolution of BPPV in about 80% of patients after a single application, and the success rate increases to 92% with repetition.¹³ By virtue of its relative ease, patients may attempt the CRM, but accurately identifying the affected canal is essential since the CRM is canal specific. Fortunately, our previous study showed that a simple 6-question questionnaire (Box) could diagnose the involved canal and type of BPPV with an accuracy of 71.2%.¹⁴ This questionnaire included 6 questions, the first 3 to screen BPPV and the next 3 to determine the subtype of BPPV based on the positioning maneuver that induces more intense vertigo.^14,15 As BPPV has an annual recurrence rate of 15% to 18%,^16,17 self-administration of the CRM may be attempted according to the questionnaire-based diagnosis whenever BPPV recurs. This trial aimed to determine the therapeutic efficacy of web-guided self-administration of CRM according to the questionnaire-driven diagnosis when BPPV recurs.

Box. Questionnaire for Self-diagnosis of Benign Paroxysmal Positional Vertigo¹⁴.

Questions

1. Do you have spinning or whirling sensation of the surroundings or yourself?

2. Do you feel dizzy mostly when your head is moved?

3. Does the dizziness last less than 3 minutes?

4. Which positional change makes you feel more dizzy?

   1. Lying down or getting out of the bed?

   2. Turning your head (or body) while lying down?

5. Which makes you more dizzy?

   1. Turning your head to the right?

   2. Turning your head to the left?

6. How long does the dizziness induced by head turning last?

   1. Less than 1 minute?

   2. More than 1 minute?

Methods

Trial Design

We conducted this multicenter, randomized, parallel-group, double-blind trial to assess the efficacy of diagnosis and treatment of BPPV using a web-based system at 4 medical centers in South Korea. The trial protocol (Supplement 1) was designed by the principal investigator and approved by the institutional review board at each participating center. Participants’ safety and the benefit-risk balance were overseen according to the data safety monitoring plan. All participants provided written informed consent. The trial was conducted in accordance with Good Clinical Practice guidelines and the principles of the Declaration of Helsinki¹⁸ and was registered with Clinical Research Information Service. The Consolidated Standards of Reporting Trials (CONSORT) reporting guideline was followed.

Trial Participants

The diagnosis of BPPV according to the Bárány Society criteria¹⁷ was based on face-to-face clinical assessment and subsequent successful treatment of BPPV by a repositioning maneuver. We excluded patients who were younger than 20 years, had multicanal BPPV (bilateral is by definition multicanal), were unable to use or have an access to a smartphone/computer, or were unable to use the program. Since patients were enrolled at the dizziness clinics of the referred-based hospitals, this study could not include the patients with BPPV but without vertigo (vestibular agnosia).¹⁹ All patients were Korean.

Randomization and Blinding

Patients were screened for participation between July 4, 2017, and February 6, 2020. When patients first developed BPPV that was successfully treated with CRM (baseline), they were enrolled and randomly assigned (1:1) to the treatment or control group using an interactive web response system provided by Research Electronic Data Capture (REDCap), version 9.5.2 (Vanderbilt University). Randomization was performed centrally. The random allocation was designed in permuted blocks with a block size of 4. The investigators assessing the outcomes and analyzing the data were independent and blinded to the patients’ information.

Procedures

After enrollment, patients were instructed to access the Stop! BPPV website²⁰ when they experienced positional vertigo again (recurrence). The patients in the treatment group were guided to complete the web-based questionnaire,¹⁴ after which they received a video clip for self-application of the CRM designed for the subtype of BPPV. In contrast, patients in the control group were provided with a video clip for the subtype of BPPV that had been diagnosed and treated at the time of study enrollment (baseline) without performing the questionnaire. Patients repeated the CRM 1 hour later. The patients’ use of the web-based questionnaire and treatment system was monitored centrally using an alert system in real time. Patients were allowed to contact the central monitoring team at any time to inquire about their symptoms and use of the web-based system.

Using a telephone interview, the efficacy of CRM self-application was judged by an independent investigator blinded to the patient’s information from 1 to 3 days (mean [SD], 1.14 [0.46]; 83.5% on the next day) after CRM completion. The interview was performed using a standardized questionnaire including 3 questions that were designed stepwise to clearly define the characteristics of dizziness that the patients experienced after the treatment since the patients with BPPV may experience residual dizziness even after successful CRM: (1) Did you have dizziness when you woke up this morning? (2) If you have dizziness, was it spinning? (3) If you have dizziness, was it related to any head position changes? If the patients answered no to any question, BPPV was determined to have been cured. Patients with persistent symptoms were asked to visit the hospital for further evaluation. Patients who could not access the web-based treatment system during the recurrence were considered to have treatment failure. Patients with no recurrence of symptoms for 2 years postenrollment were released from the study.

The questionnaire contained 6 short questions.¹⁴ The first 3 were designed to exclude patients with dizziness/vertigo due to non-BPPV disorders, and the next 3 questions determined the involved canal and BPPV subtype.¹⁴ This questionnaire was provided on the website²⁰ for the patients to access using a computer or smartphone whenever they developed vertigo.

After completion of the questionnaire, a video clip was provided on the web for patients to perform the CRM by themselves. The clip was based on the questionnaire results in the treatment group and according to the subtype of BPPV diagnosed during the previous attack in the control group. The video clips included audio instructions for proper performance of the CRM in a real-time manner (Video). The CRM recommended for each type of BPPV is listed in Table 1.²¹ Patients were followed up for recurrence at least for 2 years until February 2022.

Table 1. Canalith Repositioning Maneuvers (CRM) Adopted for Self-treatment of Each Type of BPPV.

BPPV type	PC-BPPV or AC-BPPV (opposite ear)	Geotropic HC-BPPV	Apogeotropic HC-BPPV	Non-BPPV
CRM	Modified Epley maneuver10,21	Barbecue maneuver11	Gufoni maneuver12	Brandt-Daroff exercise

Abbreviations: AC, anterior semicircular canal; BPPV, benign paroxysmal positional vertigo; HC, horizontal semicircular canal; PC, posterior semicircular canal.

Video. Web-Guided Canalith Reposition Maneuver .

Download video file ^{(124.9MB, mp4)}

English translation of the representative video clip of the canalith reposition maneuver (the modified Epley maneuver) for self-treatment of benign paroxysmal positional vertigo involving the right posterior semicircular canal.

Outcomes

The primary end point was the resolution of positional vertigo after application of the CRM. During the telephone interview, we also collected data on the perceived difficulty of using the web-based program (10-point index; range, 1-10), requirement for another person’s assistance when using the program and any falls or other adverse events related to application of the CRM.

Statistical Analysis

Estimation indicated that a sample size of 82 would have a 95% power to establish efficacy at a 5% level of significance. According to our previous studies, the accuracy of the questionnaire-based diagnosis of BPPV was approximated at 75%,¹⁴ while the probability of BPPV recurring in the same ear with the same type was less than 38%.²² When the overall success rate of CRM was set at 80%,¹³ resolution of BPPV could be expected in 60% (0.75 [accuracy of 75%] × 0.8 [success rate of 80%]) of patients in the treatment group and in 30% (0.38 [recurrence rate of same type at 38%] × 0.8 [success rate of 80%]) of patients in the control group. Based on these estimations, a sample size of 600 participants was obtained with a recurrence rate of 20% and a dropout rate of 30%. An independent data safety monitoring committee in this trial was established to monitor the safety of participants in a clinical trial. The regular review by the independent data safety monitoring committee occurred once a year. Since the calculation of the sample size was based on the predicted recurrence rate, patients more or fewer than the calculated number may be required during the research. When 30%, 60%, and 90% of the expected patients were recruited, an independent data safety monitoring committee meeting was held to determine whether the number of participants was appropriate. The independent data safety monitoring committee confirmed that the target number of recurrences was attained when more than 90% of the expected patients were recruited, and the final sample size was adjusted to 585. Therefore, the final number of participants recruited for this study was 585.

The t test was used to compare continuous variables (age), while the χ² test was adopted to compare nominal variables (sex, proportion of the patients with recurrence during the study period, and proportion of patients who did not successfully use the web-based system when positional vertigo recurred) between the groups. The Wilcoxon rank sum test was used to compare the difficulty score for using the web-based system between the groups.

The primary outcome was analyzed using both intention-to-treat and per-protocol methods. Patients who did not successfully use the web-based system were excluded from the per-protocol analysis. All tests were performed using R version 4.2.1 (R Foundation), and a P value of less than .05 was considered significant.

Results

A total of 728 patients with confirmed and treated BPPV were screened for participation (Figure 1), of which 143 patients (19.6%) were excluded, including those who could not use the internet (110 [15.1%]), declined to participate in this study (20 [2.7%]), could not perform CRM by themselves due to spinal problems (8 [1.1%]), showed multicanal BPPV (3 [0.4%]), or had cognitive dysfunction (2 [0.3%]). Thus, 585 patients were enrolled with 292 in the treatment group (mean [SD] age, 60.3 [12.8] years, 37 [64%] women) and 293 in the control group (mean [SD] age, 61.1 [13.2] years; 50 [71%] women). The baseline characteristics were similar between the groups (Table 2). Of 585 enrolled patients, 128 (21.9%) experienced positional vertigo, with no significant difference between the treatment and control groups (58 of 292 [19.9%] vs 70 of 293 [23.9%]; χ² test: 95% CI, –0.11 to 0.03; P = .24). The mean recurrence interval was 179.8 days (median [range], 127 [7-717]; IQR, 23-302) during follow-up. Of 128 patients with presumed recurrence of BPPV during the study period, 19 (14.5%) could not access the web-based system when they experienced positional vertigo again and were instructed to visit the clinic; this proportion was not significantly different between the treatment and control groups (7 of 58 [12.1%] vs 12 of 70 [17.1%]; χ² test: 95% CI, –0.17 to 0.07; P = .42). Of 19 patients, 18 (94.7%) were confirmed to have BPPV and the remaining 1 was diagnosed with resolved BPPV.

Figure 1. Flowchart for the Enrollment, Randomization, Follow-up, and Analyses.

BPPV indicates benign paroxysmal positional vertigo; CRM, canalith repositioning maneuver.

Table 2. Baseline Characteristics of the Patients.

Characteristic	No. (%)
	Treatment group (n = 292)	Control group (n = 293)
Age, mean (SD), y	60.1 (12.7)	61.1 (13.1)
Gender
Men	97 (33.2)	87 (29.7)
Women	195 (66.8)	206 (70.3)
BPPV type
Posterior	210 (71.9)	202 (68.9)
Horizontal	82 (28.1)	88 (30.0)
Anterior	0 (0.0)	3 (1.0)
Affected ear
Right	163 (55.8)	159 (54.3)
Left	129 (44.2)	134 (45.7)
No. of CRM, mean (SD)	1.8 (1.0)	1.7 (1.0)
Previous history of BPPV	156 (53.4)	151 (51.5)

Abbreviations: BPPV, benign paroxysmal positional vertigo; CRM, canalith repositioning maneuver.

In the intention-to-treat analysis, 42 of 58 patients (72.4%) in the treatment group and 30 of 70 patients (42.9%) in the control group reported vertigo resolution after application of the web-based system (χ² test: 95% CI, 0.13-0.46; P < .001; Figure 2). In the treatment group, 7 patients could not access the web-based treatment system, 4 patients had posterior canal BPPV, 1 had geotropic and another had apogeotropic horizontal canal BPPV, and the remaining 1 had resolved BPPV. Nine additional patients who used the web-based treatment system and experienced treatment failure visited the clinic for neuro-otological evaluation within 4 days postapplication (median [range], 1 [1-4]). Five of these patients were confirmed to have BPPV with the types different from those diagnosed using the web-based system, and 1 experienced treatment failure despite a correct diagnosis on the web-based system. The remaining 3 patients were classified as non-BPPV using the web-based questionnaire, but 1 had resolved BPPV and the other 2 patients were found to have posterior canal BPPV in the clinic. In the control group, 12 patients could not access the web-based system. These patients were confirmed to have posterior canal BPPV (n = 11) or apogeotropic horizontal canal BPPV (n = 1). Of 28 patients with treatment failure in the control group, 3 refused to visit the clinic for further evaluation. Of the 25 patients who visited the clinic within 4 days post-CRM administration (median [range], 1 [1-4]), 14 (56.0%) showed a type of BPPV different from that diagnosed on enrollment, 2 (8.0%) experienced treatment failure despite recurrence of the same type, 5 (20.0%) were presumed to have resolution of BPPV, and the remaining 4 (16.0%) were diagnosed with nonspecific dizziness.

Figure 2. Efficacy of the Canalith Repositioning Maneuvers.

The success rate was significantly higher in the treatment than in the control group (χ² test: P < .001).

In the per-protocol analysis, 42 of 51 patients (82.4%) in the treatment group and 30 of 58 (51.7%) in the control group reported vertigo resolution during the telephone interview (χ² test: 95% CI, 0.14-0.47; P < .001). In the treatment group, posterior canal BPPV showed a resolution in 27 of 28 (96.4%) and horizontal canal BPPV in 13 of 18 (72.2%). The remaining 5 patients were diagnosed with non-BPPV.

Patients reported using the program without difficulty. The median level of difficulty was only 1 (range, 1-10; IQR, 1-2), with no significant difference between the treatment and control groups (Wilcoxon rank sum test: P = .70). Most patients (88 of 109 [80.7%]) could use the web-based system by themselves, but 21 (19.3%) required some help from family members or a caregiver. Patients who required assistance were older than those who did not (mean [SD] age, 68.2 [10.7] vs 58.0 [13.0] years; t test: 95% CI, 4.0-16.3; P = .001).

None of the patients who used the web-based treatment system reported adverse events other than nausea, vomiting, or mild headache. No patients experienced a fall or fall-related adverse events during CRM self-administration.

Discussion

This randomized multicenter controlled trial demonstrated the efficacy of a web-based diagnosis and treatment system for recurrent BPPV. Furthermore, most patients were able to use this system without difficulty when they had a presumed recurrence of BPPV.

BPPV is the most common vestibular disorder worldwide.^5,6 Patients with BPPV are known to bear average medical expenses of $2685 per individual in the US²³ and €364 (US $381) in Spain.²⁴ In this respect, application of the web-based diagnosis and treatment system for the management of BPPV would greatly reduce the medical costs and social burden related to this highly prevalent and recurrent vestibular disorder. Indeed, 2 patients enrolled in this study were living abroad and were able to successfully treat BPPV at home when it recurred.

BPPV recurs frequently, with an annual recurrence rate of 15% to 27% and an overall incidence of recurrence of about 50% by 3 years.^16,25 Furthermore, approximately 20% of patients with recurrent BPPV experience multiple recurrences.²² Indeed, 20% of the patients enrolled in this study experienced recurrence within a half year. However, in a previous study, the type of BPPV was the same as that observed during the previous attack in only 24% of patients with idiopathic BPPV.²² Another study also found that idiopathic posterior canal BPPV recurred in the same canal only in 33% of patients.²⁶ These findings indicate a random chance of BPPV subtypes when it recurs and suggest a limited efficacy of administering the CRM according to the subtype from the previous attack. In our study, the efficacy was significantly lower in the control group than in the treatment group. The resolution of BPPV in 51.7% of patients in the control group may be explained by possible recurrence of the same type or spontaneous reduction of the otolithic debris, which is an occasional finding in BPPV.

With the advent of the fourth industrial revolution, telemedicine is expanding its scope, and its importance has grown in the COVID-19 pandemic era. Given the effectiveness of the questionnaire-based diagnosis and self-administration of the CRM in BPPV, BPPV appears to be a vestibular disorder that is highly appropriate for telemedicine and digital therapeutics. Thus, the system adopted in this study may be used for primary care physicians, particularly when making a tentative diagnosis over the telephone or during an office visit when a provocative maneuver is equivocal or cannot be done. However, the application of this web-based system is not limited to BPPV. Wearable smart devices have greatly enhanced and will further improve the management of various vestibular disorders, especially recurrent and chronic conditions.²⁷ In most vestibular disorders, the detection of abnormal eye movements, including nystagmus, is vitally important for the diagnosis. In this respect, attempts have been made to develop wearable devices to record eye movements, especially during attacks.^28,29 Further refining these technologies and merging them with the web-based diagnosis and treatment system would greatly enhance the management of vestibular disorders using telemedicine or digital therapeutics.

Limitations

Our study has several limitations. First, this study was performed only among patients with confirmed and treated BPPV. This restriction in the eligibility was for practical recruitment of patients with BPPV and aimed to ensure minimal risk in applying this web-based system to patients with acute vertigo. However, given the acceptable accuracy of the questionnaire in diagnosing de novo or recurrent BPPV, the application of this web-based system may be attempted in patients with acute vertigo to screen and treat BPPV. This possibility should be validated in the future.

Second, this web-based system could only be applied to those who can access the internet and use computers or smart devices to answer the questionnaire and administer the CRM by themselves. Thus, the application of this web-based system would be challenging for older adults with cognitive impairments, even in high-resource countries with a wide distribution of the internet and smart devices. Given the high prevalence of BPPV in elderly individuals, this factor may limit universal application of this web-based system. Indeed, 15.1% (110 of 728) of patients with confirmed BPPV did not successfully complete the screening, mostly due to difficulty in using the web-based system, and patients who did not use the system successfully were older than their counterparts. However, 27.6% (29 of 105) of patients who used this web-based system were 70 years or older.

Third, whether BPPV resolved after application of the maneuver was determined according to patients’ reports during the telephone interview. Although the observation of nystagmus triggered during positional maneuvers is the criterion standard for determining the persistence of BPPV, the disappearance of positional vertigo may be a reasonable indicator of BPPV resolution. Furthermore, we evaluated patients with persistent symptoms after CRM application in the clinics. The absence of significant adverse events also indicates the validity and safety of this approach.

Fourth, a traumatic etiology may have been overrepresented in our study since traumatic BPPV is known to recur more frequently³⁰ although we did not determine the etiology in study patients. Finally, this questionnaire-based diagnostic algorithm has a limitation to be applied for the patients with BPPV but without vertigo (vestibular agnosia).

Conclusions

This trial proved the efficacy of a web-guided self-treatment system for recurrent BPPV. Use of this system may play an important role in telemedicine for vestibular disorders.

Supplement 1.

Trial Protocol

Supplement 2.

Data Sharing Statement