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Artificial intelligence–assisted interactive health promotion systems are useful tools for the management of musculoskeletal conditions.
This study aimed to explore the effects of web-based video patient education and strengthening exercise therapy, using a mobile messaging app, on work productivity and pain in patients with chronic low back pain (CLBP) receiving pharmacological treatment.
Patients with CLBP were randomly allocated to either the exercise group, who received education and exercise therapy using a mobile messaging app, or the conventional group. For patient education, a web-based video program was used to provide evidence-based thinking regarding the importance of a cognitive behavioral approach for CLBP. The exercise therapy was developed in accordance with the recommendations for alignment, core muscles, and endogenous activation, including
The exercise and conventional groups included 48 and 51 patients, with a mean age of 47.9 years (SD 10.2 years; n=27, 56.3% male patients) and 46.9 years (SD 12.3 years; n=28, 54.9% male patients) in the full analysis set, respectively. No significant impact of these interventions on work productivity was observed in the exercise group compared with the conventional group (primary end point: Quantity and Quality method; 0.062 vs 0.114; difference between groups −0.053, 95% CI −0.184 to 0.079;
This study suggests that patient education and strengthening exercise therapy using a mobile messaging app may be useful for treating CLBP. This study does not reveal the effect of therapeutic interventions on CLBP on work productivity. Thus, further research is required to assess work productivity with therapeutic interventions.
University Hospital Medical Information Network Clinical Trials Registry UMIN000041037; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046866
Chronic low back pain (CLBP) is common in adults, with prevalence rates as high as >80% [
Low back pain (LBP) is associated with high disability. In the Global Burden of Diseases, Injuries, and Risk Factors Study 2017, LBP ranked highest in terms of years lived with disability among the 354 conditions studied over the period of 28 years [
In a retrospective, cross-sectional study using the 2014 Japan National Health and Wellness Survey data, 77.4% of 30,000 Japanese adults with CLBP reported presenteeism and had a poor quality of life (QoL) compared with those without presenteeism [
Several studies have reported that exercise alleviates CLBP and disability [
Despite these encouraging results, patients often show noncompliance with exercise therapy. Perceptions of the underlying illness and exercise therapy, lack of positive feedback, and degree of helplessness are factors related to noncompliance with exercise therapy [
The mobile messaging app Secaide (Travoss Co, Ltd) is a digital device designed to enhance the patient’s understanding of CLBP and enable remote exercise therapy for more accessible and personalized home-based pain management. The app was nicknamed
Previous studies have not clarified the impact of intervention in CLBP treatment on presenteeism in patients. As a hypothesis, we expected that therapeutic intervention for CLBP would have a positive effect on presenteeism. This study aims to explore the effects of patient education and strengthening exercise therapy on work productivity, symptoms, and QoL in patients with CLBP who were receiving medication and who continued to experience pain despite treatment. In a new attempt, we used web-based videos for patient education and a mobile messaging app to support the continuation of exercise therapy. Because of the COVID-19 pandemic, we devised methods for study continuation without any visits to clinics by the intervention in web-based remote exercise therapy and by using patient-reported outcomes (PROs) as an outcome evaluation method.
This was a multicenter, open-label, randomized, parallel-group study conducted in Japan from June 2020 to March 2021 at 16 clinics (
Study design.
The study was conducted in accordance with all the international and local laws, the principles of the
Patients who met the following criteria were included in the study: (1) having LBP for >3 months, (2) aged 20 to 64 years, (3) receiving prescribed pharmacological treatment for the pain, (4) not likely to experience any unexpected pain flare-ups for 12 weeks, (5) able to walk independently, (6) engaging in work for >3 days per week in either full-time or part-time capacity for >3 hours a day, and (7) having the skill and understanding to operate mobile communications. The CLBP diagnosis was established by qualified practicing physicians.
The key exclusion criteria were as follows: (1) aged >65 years, (2) having CLBP unrelated to a musculoskeletal condition, (3) with radiculopathy or constructive spinal deformity, (4) having LBP with red flags (with chest pain, malignant tumor, HIV infection, malnutrition, significant weight loss of ≥5% within 1 month, extensive neurological symptoms, or fever of ≥37.5 °C), (5) using over-the-counter medications for CLBP, (6) pregnant women and those who were willing to be pregnant during the clinical trial period, (7) receiving steroids (intravenous injection or oral administration) or opioids, and (8) unable to understand the Japanese language.
The patients received the prescribed pharmacological treatment, surgical treatment, and/or patient education and exercise therapy for the management of CLBP.
Information about the use of medications for pain was obtained from an electronic medical record system (Mebix, Inc). Pharmacological treatment included nonsteroidal anti-inflammatory drugs, acetaminophen, weak opioids, blood flow improvers, muscle relaxants, medications for osteoporosis, antidepressant drugs, steroids, antiepileptic drugs, and nerve-blocking agents, such as local anesthetic drugs. Medications were assessed at randomization; weeks 4, 8, and 12; and study discontinuation.
Any surgeries for pain relief were recorded at randomization; weeks 4, 8, and 12; and study discontinuation.
A web-based video program was used to provide evidence-based thinking regarding the importance of a cognitive behavioral approach for patients with CLBP. The exercise therapy was developed by Travoss Co, Ltd, in accordance with the recommendations for alignment, core muscles, and endogenous activation, including
Secaide, a mobile messaging app for mobile communication devices such as smartphones and tablets, with download enabled by a QR code, is an aid to exercise therapy. In Japan, this mobile messaging app is used for SMS text messaging and voice calls [
Examples of exercises with instructions from the artificial intelligence–assisted health program (Secaide).
Exercise menu on Secaide.
Exercise schedule on Secaide. a) One Stretch (Standing Back Extension), b) Side One Stretch, c) McKenzie Extension (Sea Lion Pose), d) Hamstring Stretch, e) Lying Waist Twist, f) Arm Leg Raise (Kneeling Superman), m) Mindfulness, n) Questionnaire.
All patients were required to respond to a web-based survey that captured demographic and background information, including occupation and exercise habits. Furthermore, pharmacological and surgical treatment for CLBP and the number of institutional visits in the last 30 days were collected at weeks 0 to 4, weeks 4 to 8, and weeks 8 to 12 and at study discontinuation.
Adherence to the use of mobile messaging app–based exercise therapy was measured by the rate of implementation (%), calculated as follows: (access days/observation period)×100. Category aggregation for the adherence rate was performed by 0% to 25%, by 25% to 50%, by 50% to 75%, and by ≥75%. Assessments were made from the log information (date) of Secaide and the PRO response date, that is, weeks 0 to 4, weeks 4 to 8, weeks 8 to 12, and weeks 0 to 12.
The primary end point was the change in work productivity at week 12. The work productivity was measured using the Quantity and Quality method (QQ method), which evaluates work productivity in terms of quality, quantity, and efficiency and is an evaluation index for absenteeism [
The secondary end points were changes in work productivity measured using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH) [
The data related to changes in WPAI-GH in a 6-week randomized study of patients with LBP were used to calculate the sample size of 100 participants [
Data were summarized using descriptive statistics of the mean (SE) for continuous variables and frequencies and percentages for categorical variables. To compare continuous data in the 2 groups, an analysis of covariance model (covariates: treatment, baseline, age, sex, and willingness to adopt the exercise therapy) or mixed-effects model for repeated measures (covariates: treatment, baseline, time, time×treatment, age, sex, and willingness to adopt the exercise therapy) was used for the primary and secondary end points, depending on the times of measurements. The Fisher exact test was used to compare the percentages in the 2 groups.
In patients who had data reported at week 12, post hoc analyses were performed to check the impact of the treatment compliance (<75% and ≥75% exercise groups and conventional group) on the primary end point (work productivity) and secondary end points (NRS of CLBP and RDQ-24). Data were analyzed using SAS (version 9.4; SAS Institute Inc).
A total of 101 patients with CLBP were recruited, and consenting participants were randomly allocated to either the exercise group (n=50, 49.5% randomized; n=48, 47.5% analyzed for efficacy), who used the web-based videos and Secaide for exercise therapy, or the conventional group (n=51, 50.5% randomized and analyzed;
Patient disposition. FAS: full analysis set.
The baseline characteristics of patients in the exercise and conventional groups are shown in
Baseline characteristics (full analysis set).
|
Exercise group (n=48) | Conventional group (n=51) | |||
|
47.9 (10.2) | 46.9 (12.3) | |||
|
<45 | 18 (37.5) | 20 (39.2) | ||
|
≥45 | 30 (62.5) | 31 (60.8) | ||
|
|||||
|
Women | 21 (44) | 23 (45) | ||
|
Men | 27 (56) | 28 (55) | ||
BMI (kg/m2), mean (SD) | 24.42 (4.05) | 23.39 (4.18) | |||
|
|||||
|
<0.5 | 3 (6) | 5 (10) | ||
|
0.5 to <1 | 3 (6) | 6 (12) | ||
|
≥1 | 42 (88) | 40 (78) | ||
|
|||||
|
Yes | 14 (29) | 19 (37) | ||
|
No | 14 (29) | 19 (37) | ||
|
Sometimes | 20 (42) | 13 (25) | ||
|
|||||
|
Yes | 42 (88) | 45 (88) | ||
|
No | 6 (13) | 6 (12) | ||
|
|||||
|
Full time (>40 hours per week) | 34 (71) | 40 (78) | ||
|
Part time | 14 (29) | 11 (22) | ||
|
|||||
|
Living alone | 10 (21) | 9 (18) | ||
|
Living with children only | 1 (2) | 4 (8) | ||
|
Living with adults only | 18 (38) | 18 (35) | ||
|
Living with adults and children | 19 (40) | 20 (39) | ||
|
|||||
|
<3 million (24,000) | 15 (31) | 10 (20) | ||
|
3 million to <5 million (24,000 to 40,000) | 14 (29) | 16 (31) | ||
|
5 million to <8 million (40,000 to 64,000) | 9 (19) | 13 (25) | ||
|
≥8 million (64,000) | 8 (17) | 7 (14) | ||
|
Decline to answer | 2 (4) | 5 (10) | ||
Education level (completed university education), mean (SD) | 25 (52.1) | 22 (43.1) | |||
|
|||||
|
Yes | 17 (35) | 18 (35) | ||
|
No | 12 (25) | 22 (43) | ||
|
Sometimes | 19 (40) | 11 (22) | ||
|
|||||
|
Never smoked | 23 (48) | 26 (51) | ||
|
Former smoker | 14 (29) | 15 (29) | ||
|
Current smoker | 11 (23) | 10 (20) | ||
|
|||||
|
Performance degradation | 0.51 (0.303) | 0.516 (0.314) | ||
|
Days of work loss due to poor performance | 10.466 (8.485) | 12.409 (9.956) | ||
|
|||||
|
Work time | 4.3 (12.4) | 8.2 (21.8) | ||
|
Impairment while working | 35.3 (29.8) | 45.6 (33.2) | ||
|
Overall work impairment | 37.0 (30.7) | 47.7 (34.4) | ||
|
Activity impairment | 47.2 (31.6) | 50.4 (29) | ||
|
|||||
|
CLBP | 5 (2.4) | 5.1 (2.1) | ||
|
Shoulder stiffness | 4.5 (3.0) | 4.5 (2.8) | ||
RDQ-24,e mean (SD) | 8.6 (5.3) | 7.4 (4.7) | |||
EQ-5D-5L,f mean (SD) | 0.720 (0.195) | 0.746 (0.142) | |||
TSK-11,g mean (SD) | 26.4 (6.1) | 24.6 (6.6) | |||
K-6,h mean (SD) | 6.2 (5.6) | 5 (4.9) | |||
|
|||||
|
Hospital | 1.9 (1.7) | 2.1 (2.3) | ||
|
Clinic | 0.8 (1.6) | 1.1 (2.5) | ||
|
Acupuncture and moxibustion clinic | 0.2 (0.8) | 0.1 (0.2) | ||
|
Manipulative clinic | 0.8 (1.7) | 0.8 (1.9) | ||
|
Others | 0.3 (1.0) | 0.4 (0.9) |
aCLBP: chronic low back pain.
bQQ method: Quantity and Quality method.
cWPAI-GH: Work Productivity and Activity Impairment Questionnaire: General Health.
dNRS: Numerical Rating Scale.
eRDQ-24: Roland-Morris Disability Questionnaire.
fEQ-5D-5L: EuroQoL 5 Dimensions 5 Level.
gTSK-11: Tampa Scale for Kinesiophobia.
hK-6: Kessler Screening Scale for Psychological Distress.
Compliance rates for the use of mobile messaging app–based exercise therapy during the study duration. Exercise status is evaluated by access log to Secaide within a specified period. Percentage of patients (%)=(access days/observation period)×100. Category aggregation for the rate of adherence was performed by 0% to 25% (blue), 25% to 50% (orange), 50% to 75% (gray), and ≥75% (yellow).
At week 12, the mean change (SE) in work productivity (QQ method) in the exercise group (n=37) and the conventional group (n=32) was 0.062 (0.069) and 0.114 (0.069), respectively (difference between groups −0.053, 95% CI −0.184 to 0.079;
Changes in the WPAI-GH parameters in the 2 groups at week 12 are shown in
Changes in Work Productivity and Activity Impairment Questionnaire: General Health parameters and QoLa at week 12.
Parameter | Exercise group, least squares mean (SE) | Conventional group, least squares mean (SE) | Difference between groups in the 12 weeks, least squares mean (95% CI) | ||
|
36b (100) | 26 (100) | N/Ac |
|
|
|
Work time | 3.8 (3.4) | 1.2 (4.1) | 2.7 (−5.4 to 10.7) | .51 |
|
Impairment while working | −16.5 (6.2) | −6.8 (6.9) | −9.6 (−23.3 to 4.1) | .17 |
|
Overall work impairment | −13.3 (6.8) | −4.7 (7.6) | −8.6 (−23.6 to 6.5) | .26 |
|
Activity impairment | −16.7 (5.7) | −6.4 (6.7) | −10.3 (−23.6 to 3.0) | .13 |
|
38 (100) | 34 (100) | N/A |
|
|
|
RDQ-24d | −2.1 (0.8) | −0.3 (0.9) | −1.9 (−3.7 to 0.0) | .05 |
|
EQ-5D-5Le | 0.068 (0.024) | 0.006 (0.026) | 0.061 (0.008 to 0.114) | .03 |
aQoL: quality of life.
bData for activity impairment due to health were analyzed for 37 patients.
cN/A: not applicable.
dRDQ-24: Roland-Morris Disability Questionnaire.
eEQ-5D-5L: EuroQoL 5 Dimensions 5 Level.
At week 12, although no statistically significant difference in the reduction of the NRS scores was observed between the exercise (mean −1.1, SE 0.3) and conventional groups (mean −0.7, SE 0.4;
At week 12, no statistically significant differences in the RDQ-24 scores were observed between the exercise and conventional groups. A significant improvement in EQ-5D-5L at week 12 was observed in the exercise group compared with that in the conventional group (
At week 12, a significant improvement in the TSK-11 score was observed in the exercise group (mean −2.3, SE 1.2) compared with that in the conventional group (mean 0.5, SE 1.3; difference between groups −2.8, 95% CI −5.5 to −0.1;
At week 12, no significant improvement in the K-6 score was observed in the exercise group (mean −1.5, SE 0.8) compared with that in the conventional group (mean −0.6, SE 0.9; difference between groups −0.9; 95% CI −2.7 to 0.9;
Visits to clinics were significantly reduced in the exercise group at weeks 4, 8, and 12. Similarly, a significant reduction in visits to the acupuncture and moxibustion clinics was observed in the exercise group at weeks 4 and 8 (
No differences for surgical treatment or changes in drug use were observed in the conventional or exercise group throughout the study period.
In this study, no significant difference in work productivity (QQ method), pain intensity, and RDQ-24 was observed in the exercise group. As a post hoc analysis, the effects of exercise therapy on work productivity (QQ method), pain intensity, and RDQ-24 were examined in the group with a high compliance rate of exercise (≥75%) and the other groups (<75% compliance). At week 12, patients who showed a higher (≥75%) adherence to the exercise regimen had a greater improvement in work productivity (QQ method), NRS scores, and RDQ-24 than those with <75% adherence or the conventional group (
Change from baseline of work productivity, CLBP,a and quality of life among treatment compliances at week 12 (post hoc analysis).b
Parameters | Exercise group compliance ≥75% (n=18), least squares mean (95% CI) | Exercise group compliance <75% (n=20), least squares mean (95% CI) | Conventional group (n=34), least squares mean (95% CI) |
Work productivity (QQ methodc) | 0.00 (−0.14 to 0.15) | 0.05 (−0.11 to 0.21) | 0.08 (−0.03 to 0.18) |
CLBP (NRSd) | −2.28 (−3.47 to −1.09) | −0.15 (−1.03 to 0.73) | −0.91 (−1.48 to −0.34) |
Quality of life (RDQ-24e) | −3.06 (−4.45 to −1.66) | −2.20 (−4.51 to 0.11) | −0.76 (−2.15 to 0.62) |
aCLBP: chronic low back pain.
bNo statistical tests were performed.
cQQ method: Quantity and Quality method.
dNRS: Numerical Rating Scale.
eRDQ-24: Roland-Morris Disability Questionnaire.
The exercise intervention is considered an integral part of CLBP management and has been reported to reduce pain and improve function in patients with CLBP; however, there are challenges in exploring effective exercise types and continuing exercise [
The web-based video patient education and strengthening exercise therapy using the mobile messaging app did not show any significant changes in work productivity or loss of workdays due to CLBP at week 12 compared with the conventional pharmacological treatment in this study. To the best of our knowledge, there is no randomized controlled trial with the intervention outcome to improve work productivity in patients with CLBP; therefore, this result cannot be compared with previous studies. It is possible that drastic changes in the working environment during the COVID-19 pandemic affected the assessment of work productivity. During the research period, the Government of Japan began to recommend remote work as a national policy. In the evaluation of work productivity, the quantity and quality of work at the time of evaluation were compared with those in the absence of CLBP. The effect of changes in working style might be greater than that of exercise therapy on work productivity. A survey of workers in remote work before and during the COVID-19 pandemic conducted in Japan in 2020 also reported that full remote work of 5 days a week reduced work productivity [
The use of mobile devices can enhance patient engagement in self-management of CLBP and improve exercise compliance [
In this study, many end points, rather than the primary end point, showed results similar to those of previous studies. In particular, the degree of the subjective score of pain was significantly improved in workers who received exercise therapy, which is consistent with a previous study using Secaide [
Kinesiophobia is a therapeutic target with exercise regimens in the management of CLBP [
In addition, a post hoc analysis was used to evaluate the relationship between exercise therapy adherence and outcomes. High adherence showed good outcomes in work productivity (QQ method), CLBP score (NRS), and RDQ-24 score. Recently, evaluation using PROs has attracted attention in clinical trials [
In this study, we adopted the Secaide app [
This study had certain limitations. Changes in work quality and quantity were used as outcomes for work productivity. This study was conducted during the COVID-19 pandemic, when the social working environment has evolved with the adoption of remote working. Furthermore, these changes in the work environment may have influenced the evaluation of work productivity. The study design has the inherent limitations of a short duration (12 weeks) and a small sample size (50 in each group). There have been no previous studies with the same patient population and end point, and the required number of cases was calculated using the results of secondary end point of this study. As a result, the statistical power of this study may be lower than expected. We did not assess the rate of adherence to prescribed medications, which could possibly impact work productivity outcomes with exercise therapy using the mobile messaging app. The data for the study outcomes were self-reported, and a response bias could have led to varying estimates of the severity of CLBP. Comparison of the high adherence group with the other groups should be interpreted in a limited manner because of the results of the post hoc analysis.
Web-based patient education and strengthening exercise therapy using the Secaide app may be useful for enhancing the effectiveness of exercise therapy in the treatment of CLBP. In this exploratory study, the exercise group showed consistently better trends for most end points than did the conventional group. The adherence to exercise therapy improved work productivity, NRS for CLBP, and RDQ-24, suggesting that the mobile messaging app is useful for CLBP treatment.
This study did not reveal the effect of therapeutic interventions on CLBP on work productivity. Further research is required to assess work productivity with therapeutic interventions.
Study clinics and investigators.
Change from baseline in the mean number of consultations in the exercise and conventional groups.
CONSORT-EHEALTH checklist (V 1.6.2).
chronic low back pain
EuroQoL 5 Dimensions 5 Level
low back pain
minimal clinically significant difference
Numerical Rating Scale
patient-reported outcome
quality of life
Quantity and Quality method
Roland-Morris Disability Questionnaire
Standard Protocol Items: Recommendations for Interventional Trials
Tampa Scale for Kinesiophobia
Work Productivity and Activity Impairment Questionnaire: General Health
The authors would like to thank all clinical investigators and patients for their participation in the study. This work was supported by Shionogi & Co, Ltd, Osaka, Japan. All named authors meet the International Committee of Medical Journal Editors criteria for authorship for this manuscript, take responsibility for the integrity of the work, and have given final approval for the version to be published. The authors thank Dr Tarveen Jandoo and Raghuraj Puthige, PhD of Enago Life Sciences, for medical writing and editorial support in the preparation of this manuscript, which was funded by Shionogi & Co, Ltd. The authors would also like to acknowledge the editorial assistance provided by Noriyuki Naya, PhD and CMPP, of Shionogi & Co, Ltd, in the preparation of this paper.
NI, HM, YY, and MY are employees and minor stockholders of Shionogi & Co, Ltd. KM is a shareholder and an adviser of Trunk Solution Co, Ltd, and received the following support: a research grant from the Ministry of Health, Labour and Welfare; grant support from Sompo Holdings, Inc, MS&AD InterRisk Research & Consulting, Inc, Inotech Co, Ltd, NUVASIVE Japan MTG Co, Ltd, DeNA, Medical Data Scientist and Medical AI Device Development Organization, The Association for Preventive Medicine of Japan, and Murata Manufacturing Co, Ltd, including personal fees from Nippon Zoki Pharmaceutical Co, Ltd, Ono Pharmaceutical Co, Ltd, Chugai Pharmaceutical Co, Ltd, AYUMI Pharmaceutical Corporation, and Shionogi & Co, Ltd; and lecture fees from Eli Lilly Japan K.K, Pfizer Japan Inc, and Hisamitsu Pharmaceutical Co, Inc, from outside the submitted work. HO reports personal fees received from AYUMI Pharmaceutical Corporation, Nippon Zoki Pharmaceutical Co, Ltd, Ono Pharmaceutical Co, Ltd, Sompo Holdings, Inc, NuVasive Japan, Inc, Promotion of Practical Use of AI Medical Diagnosis Support Equipment, MS&AD InterRisk Research & Consulting, Inc, Inotech Corporation, Chugai Pharmaceutical Co, Ltd, The Association for Preventive Medicine of Japan, Shionogi & Co, Ltd, and MTG Co, Ltd; and grants from Pfizer Inc, outside of the submitted work.