This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on https://www.jmir.org/, as well as this copyright and license information must be included.
Chronic headache causing severe headache-related disability for those affected by the disease is under- or misdiagnosed in many cases and therefore requires easy access to a specialist for optimal health care management.
The goal of the research is to determine whether video consultations are noninferior to face-to-face consultations in treating chronic headache patients referred to a specialist in Northern Norway.
Patients included in the study were recruited from general practice referrals to a specialist at a neurological department in Northern Norway (Tromsø) and diagnosed according to the International Headache Society classification system. In a randomized controlled design, the 1-year remission rate of chronic headache (change from ≥15 to <15 headache days per month during the last 3 months), patient satisfaction with a specialist consultation, and need for follow-up consultations by general practitioners were compared between groups consulted by video and face-to-face in a post hoc analysis. Data were collected by interview (baseline) and questionnaire (follow-up).
From a baseline cohort of 402 headache patients consecutively referred from general practice to a specialist over 2.5 years, 58.0% (233/402) were classified as chronic headache and included in this study. Response rates were 71.7% (86/120) in the video group and 67.3% (76/113) in the face-to-face group. One-year remission from chronic headache was achieved in 43.0% (37/86) in the video group and 39.5% (30/76) in the face-to-face group (
One-year remission rate from chronic headache was about 40% regardless of consultation form. Likewise, patient satisfaction with consultation and need for follow-up visits in general practice post consultation was similar. Treating chronic headache patients by using video consultations is not inferior to face-to-face consultations and may be used in clinical neurological practice.
ClinicalTrials.gov NCT02270177; https://clinicaltrials.gov/ct2/show/NCT02270177
Chronic headache is a condition that transforms from primary headaches and is mainly identified as chronic migraine and chronic tension-type headache affecting about 1% to 2% and 2% of the population, respectively [
The results from this study are based on post hoc analyses from a previous open-label randomized clinical trial where a larger group (n=409) of heterogeneous headache patients referred from general practitioners (GPs) to specialists were assigned to either video or face-to-face (in-office) consultations to study cost, feasibility, and clinical aspects [
Patients were consecutively identified, screened, randomized, and consulted for 2.5 years (September 30, 2012, to March 30, 2015). Of the included patients, 58.0% (233/402) of patients were classified to have chronic headache and included in the study (
Flowchart of patients with chronic headache referred to neurologists from general practitioners for headache fulfilling the study inclusion criteria.
Selection criteria were as follows: (1) patients referred from GP to neurologist for headache, (2) fulfilling the classification criteria for chronic headache without evidence of secondary headache (ie, headaches classified as primary headache without specific causes [
A nurse welcomed the participants at the entrance of the neurological department at the Tromsø University Hospital, checked the patient’s self-administered prefilled forms and participation consent and called the randomization administrator at the hospital (Centre for Quality Improvement and Development). Participants were block-randomized by using an Rnd function in Access (Microsoft Corp), and thereafter guided to an examination room for face-to-face consultation (traditional group) or to the video conference room located next to the department (video group). Video consultations were performed by using a video conference system including a C40 Integrator package (Cisco Systems Inc) with dual display option and Touch Control Device for C Series, C40 Integrator Multisite (Cisco Systems Inc), Precision HD 1080
Data were obtained by structured interview at baseline and via questionnaire at 1-year follow-up. The prefilled forms included a Headache Impact Test–6 (HIT-6) measuring 6 items of headache impact (pain, social, role and cognitive functioning, vitality, and psychological distress). Every question was answered by never, rarely, sometimes, very often, or always, and each answer scored 6, 8, 10, 11, or 13 points, respectively [
Secondary end points were recorded from the patients’ registration form as follows: “Where you satisfied with the consultation?” (yes or no), “Have you consulted your GP for headache after the specialist consultation?” (yes or no), and “Number of headache consultations with GP after the specialist consultation.” Also, use of painkillers, triptans, and preventive headache drugs used in the last month were recorded.
Oral and written consent were obtained from all participants before study entrance. The Norwegian National Committee for Medical and Health Research Ethics approved the study (number 2009/1430/REK).
Data were analyzed with SPSS (version 27, IBM Corp). Descriptive variables are compared between the randomized groups and presented as mean and standard deviation or median and interquartile range in skewed distributed data (number of GP consultations). Consequently, comparisons between groups were analyzed by independent Student
Patients’ characteristics were similar for both video and traditional consultations in all aspects including education and headache characteristics except for younger age in the video group (
Clinical characteristics in randomized groups of patients referred to specialist for chronic headache consulted by video or traditionally.
Characteristic | Chronic headache at baseline | Remission from chronic headache at 12 months | ||||||||||||
|
Video |
Face-to-face |
Video |
Face-to-face |
||||||||||
One-year response, n (%) | 86 (71.7) | 76 (67.3) | .52 | —a | — | — | ||||||||
Females, n (%) | 86 (71.7) | 84 (74.3) | .66 | 30 (72.1) | 21 (70.0) | .39 | ||||||||
Age (years), mean (SD) | 35.2 (12.8) | 40.0 (13.7) | .006 | 38.3(12.4) | 41.2 (14.6) | .38 | ||||||||
Education (years), mean (SD) | 13.2 (2.9) | 14.0 (3.1) | .07 | 13.3 (2.7) | 13.9 (3.0) | .42 | ||||||||
Sick leave (headache, weeks), n (%) | 42 (35.0) | 43 (38.1) | .68 | 11 (29.7) | 12 (40.0) | .58 | ||||||||
Waiting time to specialist (days), mean (SD) | 59.0 (29.0) | 55.2 (26.1) | .29 | 58.7 (25.5) | 46.9 (23.5) | .06 | ||||||||
Consultation duration (minutes), mean (SD) | 40.2 (9.8) | 46.5 (13.0) | <.001 | 41.0 (8.1) | 45.8 (8.8) | .02 | ||||||||
BMI (mg/m2), mean (SD) | 27.1 (5.5) | 26.9 (5.7) | .79 | 27.8 (4.5) | 28.6 (7.5) | .35 | ||||||||
Obesity, BMI ≥30, n (%) | 31 (25.8) | 29 (25.7) | >.99 | 27 (73.0) | 20 (66.7) | .58 | ||||||||
Without comorbidity, n (%) | 62 (51.7) | 52 (46.0) | .54 | 18 (48.6) | 13 (43.3) | .81 | ||||||||
Chronic neck pain, n (%) | 56 (46.7) | 57 (50.4) | .60 | 20 (54.1) | 14 (46.7) | .63 | ||||||||
Insomnia, n (%) | 80 (66.7) | 72 (63.7) | .68 | 9 (24.3) | 10 (33.3) | .43 | ||||||||
Hypertension, n (%) | 11 (9.2) | 17 (15.0) | .23 | 5 (13.5) | 4 (13.3) | >.99 | ||||||||
Age at headache onset (years), mean (SD) | 24.4 (14.3) | 27.7 (14.7) | .09 | 26.1 (15.3) | 30.2 (15.8) | .29 | ||||||||
Headache duration (years), mean (SD) | 12.2 (12.8) | 13.6 (14.6) | .35 | 13.2 (13.2) | 15.3 (16.0) | .58 | ||||||||
|
||||||||||||||
|
Migraine | 90 (75.0) | 84 (74.3) | >.99 | 31 (83.8) | 23 (76.6) | .79 | |||||||
|
Tension-type | 23 (19.2) | 28 (24.8) | .34 | 6 (16.2) | 6 (20.0) | — | |||||||
|
Other | 7 (5.8) | 1 (0.9) | — | 0 (0) | 1 (3.3) | — | |||||||
Medication ≥15 days/monthc, n (%) | 39 (32.5) | 40 (35.4) | .68 | 8 (21.6) | 3 (10.0) | — |
aNot applicable.
bMost prominent headache subtype given by specialist.
cUse of painkillers and/or triptans ≥15 days per month last 3 month.
Diagnostic changes and preventive chronic headache treatment given by neurologist. Comparisons between groups of patients randomized to either video or traditional consultations.
Variable | Persistent chronic headache at 12 months | Remission from chronic headache at 12 months | |||||
|
Video |
Face-to-face |
Video |
Face-to-face |
|||
New headache diagnosis, n (%) | 15 (30.6) | 9 (19.6) | .25 | 9 (24.3) | 9 (30.0) | .78 | |
|
26 (53.1) | 29 (63.0) | .41 | 26 (70.3) | 21 (70.0) | >.99 | |
|
Antihypertensive | 9 (18.4) | 5 (10.9) | —a | 9 (24.3) | 3 (10.0) | — |
|
Antiepileptic | 6 (12.2) | 7 (15.1) | — | 7 (18.8) | 6 (20.0) | — |
|
Antidepressant | 11 (22.5) | 17 (37.0) | — | 10 (27.0) | 12 (40.0) | — |
Triptans, n (%) | 19 (38.8) | 14 (30.4) | .55 | 11 (29.7) | 6 (20.0) | .41 |
aNot applicable.
Remission rates from chronic headache (primary end point), patient’s satisfaction with consultation and general practitioner consultations (secondary end points), headache-related symptoms, and therapy in the 12 months after specialist consultation. Patients randomized to either video or traditional consultations.
Variables | Persistent chronic headache at 12 months | Remission from chronic headache at 12 months | |||||
|
Video |
Face-to-face |
Video |
Face-to-face |
|||
Remission rate from CHa (%)b | —c | — | — | 37/86 (43.0) | 30/76 (39.5) | .38 | |
Persistent CH (%)b | 49/86 (57.0) | 46/76 (60.5) | .38 | — | — | — | |
Patient satisfaction with consultation, n (%) | 42 (85.7) | 41 (89.1) | .41 | 32 (86.5) | 28 (93.3) | .25 | |
GPd consultations, n (%) | 29 (59.2) | 20 (43.5) | .12 | 11 (29.7) | 16 (53.3) | .03 | |
GP consultations, median (IQR range) | 2 (0-11) | 1 (0-11) | .04 | 1 (0-13) | 1.5 (0-15) | .19 | |
HITe -6, baseline, mean (SD) | 64.0 (5.6) | 64.9 (4.6) | .38 | 66.0 (3.9) | 63.7 (6.4) | .09 | |
HIT-6 after 1 year, mean (SD) | 58.3 (8.8) | 61.6 (7.8) | .10 | 59.9 (10.5) | 59.2 (8.2) | .98 | |
∆HIT-6, mean (SD) | 5.7 (9.3) | 3.3 (8.7) | .08 | 5.5 (12.4) | 5.8 (9.6) | .92 | |
VASf, baseline, mean (SD) | 6.9 (2.3) | 6.9 (2.1) | .95 | 7.0 (2.1) | 6.8 (2.0) | .66 | |
VAS after 1 year, mean (SD) | 5.2 (2.8) | 6.6 (2.0) | .02 | 5.3 (2.8) | 5.2 (3.2) | .94 | |
∆VAS, mean (SD) | 1.7 (3.8) | 0.3 (3.5) | .01 | 1.7 (3.3) | 1.6 (3.5) | .80 | |
Analgesic use, n (%) | 38 (77.6) | 39 (84.8) | .44 | 34 (91.9) | 29 (96.7) | .62 | |
Medication ≥15 days/monthg, n (%) | 27 (55.1) | 23 (50.0) | .48 | 8 (21.6) | 3 (10.0) | — |
aCH: chronic headache.
bCalculated by using response rates (per protocol analyses) as reference.
cNot applicable.
dGP: general practitioner.
eHIT: headache impact test.
fVAS: visual analog scale.
gUse of painkillers and/or triptans ≥15 days per month last 3 months.
When taken data from the groups together (pooled data), the comparisons between baseline and status after 12 months were as follows: remission rate from chronic headache was 41.4% (67/162) and numbers visiting GPs were 30.2% (49/162) of those with persisting chronic headache and 40.3% (27/67) in the chronic headache remission group (
By managing new referred chronic headache patients at a secondary neurological center, the 1-year results from this post hoc RCT showed that consulting a neurological specialist by using video were equivalent to face-to-face consultations. Thus, we found no significant differences in remission rate from chronic headache, patient satisfaction with consultation, or GP visits due to headache conducted in the 1-year follow-up period. This study provides evidence to support specialist video consultations as a good alternative to face-to-face consultations in treating patients with chronic headache.
There are no previous studies comparing consultation forms in treating chronic headache by a specialist, but in an earlier RCT the group of chronic headache patients randomized to an internet-delivered self-managing relaxation program (n=39) improved by 47% on measures of self-reported headache symptoms compared to an equivalent control group recruited from the waiting list with symptom monitoring only [
In our study, approximately 40% of the chronic headache patients had remitted 1-year postconsultation while about 60% persisted with chronic headache. This rate of remission is somewhat lower than a previous longitudinal study that showed a 40% persistent rate at 1 year and 25% at 2-year follow-up [
In general, RCTs in eHealth are few despite occurrence of the COVID-19 pandemic situation, which has demonstrated a need for more evidence-based knowledge about the use of digital health technology in evaluating treatment effect, safety, and other aspects of patient management [
This post hoc study containing a 53% sample of the original cohort of headache sufferers may be prone to statistical type 2 failure due to risk of underpowered sample size, although the video and traditional consultation groups were similar with respect to group sizes and most of the social and clinical characteristics reflecting a design resistant to selection bias. Moreover, such a study lacks a placebo group and blinding, which would have optimized the evidence further. Awareness of the fact that this study compares different consultation forms and not specific treatment options should be emphasized. Interim analyses comparing additional clinical information between patient groups within the 1-year follow-up period might extend the knowledge about patient experiences with video consultations and should be performed in future studies. Additionally, consecutively including patients from clinical practice and a relatively low dropout rate accounts for acceptable generalizability.
This RCT of video consultations for new referrals of chronic headache patients demonstrated that chronic headache remission rate, patient satisfaction with specialist consultation, and GP consultations for headache performed during follow-up were equivalent between the video group and the face-to-face group. This study adds to the documentation of eHealth in consulting headache patients by specialist.
CONSORT-eHEALTH checklist (V 1.6.1).
Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online TeleHealth
general practitioner
Headache Impact Test–6
randomized controlled trial
visual analog scale
Jorun Willumsen, Anna-Kirsti Kvitnes, Marlen Lauritsen, Nora Bekkelund, Karin Flatekval Eines, Torill Erdahl, Marianne Røst, and Grethe Berg Johnsen are acknowledged for skillful help with patient logistics and data acquisition. The publication charges for this article have been funded by a grant from the publication fund of the Arctic University of Norway. The Northern Norway Regional Health Authority funded this study.
SIB contributed to the conception and design, data collection, statistical analysis, and interpretation of data, wrote the article, and approved the final version. KIM contributed with data collection, revision of the manuscript, and approval of the final version.
None declared.