A pilot study on app-based treatment, combining physical exercise, graded activity, and pain journaling for patients with spinal complaints.

The incidence of spinal complaints is increasing in our ageing population. Back
pain is amongst the conditions with the highest burden of disease in terms of
years lived with disability (YLD), with a global lifetime prevalence of about
80%. The global prevalence of spine-related complaints is 9.4%, and this
increases with age, reaching 19-23% by the age of 80 [1, 2]. Besides age,
spine-related disorders are also associated with a sedentary lifestyle and
obesity [3]. Consequently, as our population ages and rates of obesity and
physical inactivity increase, the number of patients with spine-related
disorders is rising exponentially [3-5]. Besides causing significant pain and
impairment, spinal complaints also impose an economic burden on healthcare
systems worldwide. This economic burden is reflected by considerable
healthcare-related costs and indirect costs such as loss of productivity [6-8].
Traditional conservative interventions, such as physical therapy,
pharmacological management, and lifestyle modifications are the most widely
used modes of treatment for most spinal complaints, mainly back pain [9-11]. It
should be noted that there is conflicting evidence on the effect of most of
these treatments, although there might be evidence for their effectiveness in
the short term. It is apparent that physical therapy and lifestyle
modifications focused on physical activity are the most successful options to
achieve long term results [12, 13].
The digital revolution in the healthcare sector, characterized by rapid
proliferation of health apps, offers promising avenues for innovative treatment
modalities. These app-based interventions have potential to deliver
personalized treatment regimens, provide real-time feedback, and enhance
patient engagement, from the convenience of a patient's mobile device [14].
Another possible benefit of app-based treatments is the wide availability and
scalability at relatively low costs, especially when compared to traditional
treatments [15, 16].
While these digital tools hold promise, there remains a critical need to assess
their efficacy. Studies of healthcare apps in other fields have shown mixed
results, with most indicating promising outcomes from app-based interventions,
while some suggest only small benefits, like traditional treatment modalities
[17, 18]. As evidence within spinal care is limited, our study seeks to provide
a comprehensive evaluation of the efficacy of an app-based treatment for spinal
complaints that do not require a specific intervention.


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3. Hartvigsen, J., et al., What low back pain is and why we need to pay
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4. WHO, Obesity and overweight. 2021.
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6. Smith, E., et al., The global burden of other musculoskeletal disorders:
estimates from the Global Burden of Disease 2010 study. Annals of the rheumatic
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and neck problems. Jama, 2008. 299(6): p. 656-664.
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9. Bredow, J., et al., [Conservative treatment of nonspecific, chronic low back
pain : Evidence of the efficacy - a systematic literature review]. Orthopade,
2016. 45(7): p. 573-8.
10. O'Keeffe, M., et al., Comparative Effectiveness of Conservative
Interventions for Nonspecific Chronic Spinal Pain: Physical,
Behavioral/Psychologically Informed, or Combined? A Systematic Review and
Meta-Analysis. J Pain, 2016. 17(7): p. 755-74.
11. Chou, R., et al., Nonpharmacologic therapies for low back pain: a
systematic review for an American College of Physicians clinical practice
guideline. Annals of internal medicine, 2017. 166(7): p. 493-505.
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acute and chronic nonspecific low back pain: a systematic review of randomized
controlled trials of the most common interventions. Spine, 1997. 22(18): p.
2128-2156.
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pain: evidence of the efficacy-a systematic literature review. Der Orthopäde,
2016. 45: p. 573-578.
14. Krebs, P. and D.T. Duncan, Health app use among US mobile phone owners: a
national survey. JMIR mHealth and uHealth, 2015. 3(4): p. e4924.
15. Mahtta, D., et al., Promise and perils of telehealth in the current era.
Current cardiology reports, 2021. 23: p. 1-6.
16. Loohuis, A.M., et al., Cost*effectiveness of an app*based treatment for
urinary incontinence in comparison with care*as*usual in Dutch general
practice: a pragmatic randomised controlled trial over 12 months. BJOG: An
International Journal of Obstetrics & Gynaecology, 2022. 129(9): p. 1538-1545.
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Primary Objective:
To assess the effectiveness of an app-based treatment combining physical
therapy, graded activity, and pain journaling, in improving health-related
quality of life measured with the EuroQol 5 dimensions (EQ-5D-5L) in patients
with spinal complaints who would receive physical therapy, general lifestyle
advice, or an expectant treatment in current practice.

Secondary Objectives:
1. To assess the change in pain, measured with the Visual Analogue Scale (VAS).
2. To assess the change in disability, measured with the Oswestry Disability
Index (ODI).
3. To assess the change in catastrophizing of pain, measured with the Pain
Catastrophizing Scale (PCS).
4. To assess the change in lost productivity, measured with missed working
days.
5. To assess change in Body Mass Index, measured using patients* input on
length and weight.
6. To evaluate the adherence of participants, measured using frequency of
patients* input in the mobile application.
7. To evaluate the patients* experience and satisfaction qualitatively, using
semi-structured face-to-face interviews.
8. To evaluate the safety of the intervention, measured based on the occurrence
of (serious) adverse events. Adverse events reported spontaneously by the
subject or observed by the investigator or medical staff will be recorded.

Hypothesis:
An app-based treatment combining physical therapy, graded activity, and pain
journaling is effective in increasing health-related quality of life in the
studies population.

A prospective pilot study with a treatment and follow-up duration of three
months will be conducted in Zuyderland Medical Centre Heerlen, the Netherlands.
The follow-up period of three months is chosen, as it is deemed appropriate to
allow for a comprehensive evaluation of the app's usability, acceptance, and
initial efficacy in managing spinal complaints. Moreover, a short study period
reduces recall bias in qualitative data. A longer follow-up period, e.g. one
year, would provide more data on long-term effects, but is beyond the scope of
this pilot study.
This study includes patients with spinal complaints who would receive physical
therapy, general lifestyle advice, or an expectant treatment, in current
practice and do not require another specific treatment or surgical
intervention. Patients eligible for inclusion will be referred to the
researchers. The researchers will inform the patient, and when they are willing
to participate and meet the inclusion criteria, include them. Patients will
provide informed consent when first logging into the treatment app.

5.1 Investigational product/treatment
The app-based treatment consists of a combination of physical therapy, graded
activity, and pain journaling. The app will be installed on the participant's
mobile device. The app will be used anonymously, and patients use their unique
study code to activate the app.

Physical therapy
Patients are instructed to perform several stretches daily. It is advised to
perform each stretch for 20-30 seconds. Patients will receive information on
how to properly perform these stretches through text, images, and optional
videos. The included stretches are:
1. Cat-cow stretch or a combination of pelvic tilts and knees to chest stretch.
2. Seated or standing hamstring stretch.
3. Kneeling or standing hip flexor stretch.
4. Seated or lying thoracic rotations.

Graded activity
In the graded activity section of the app, patients chose either walking or
bicycling, based on their own preferences. Both graded activity programmes have
the same structure. The program starts with a baseline self-assessment.
Patients determine how many minutes they can perform the activity before the
pain reaches VAS 7 (significant pain). This number of minutes is then applied
in the graded activity program. Pain scores are monitored during and after
activity.

Frequency: Once every day. If the duration of the activity exceeds 10 minutes,
the frequency is adjusted to once every two days.
Duration: Start with a duration that 70% of the baseline assessment. For
instance, if the patient can walk for 10 minutes before pain intensifies to a
level at which the patient has to stop, start with 7 minutes.
Pain Score Monitoring: If the planned activity is not reached due to pain, the
duration of activity is not adjusted.
Incremental Increase: Increase the duration by 10% after each activity without
significant pain, with a minimal increase of one minute.
Steady State: If the patient is able to walk for longer than half an hour
without significant pain, no adjustments are made.

Pain Journaling
The app incorporates pain and symptom journaling. The app uses graphics to
provide patients with insight on the symptoms, exercise frequency and activity.
The following components are included:
1. Daily: Exercises logging, VAS back pain score & analgesics used
(paracetamol, NSAIDs, opioids, neuropathic analgesics, other).
2. Seven - three times a week, depending on level of activity: activity
(minutes) and VAS back pain during and after activity: activity (minutes) and
VAS back pain during and after activity.
3. Monthly: Health-related quality of life (EQ-5D-5L), disability (Oswestry
Disability Index), pain catastrophizing (PCS), weight (kilograms), work
absenteeism (days, including unpaid work).

The nature and extent of the burden associated with participation in our
app-based treatment program primarily involve adherence to the recommended
activities and inputting relevant health data. Adherence to the prescribed
activity and inputting data will take several minutes per day. Based on
tolerance to activity, this may amount to a maximum of three hours per week.
Given that we are integrating existing treatment modalities such as physical
therapy, graded activity, and pain journaling, the risks associated with
participation are minimal, as these interventions are already deemed safe and
widely practiced. Participants can expect benefits such as improved pain
management, enhanced physical function, and better overall well-being.
Additional educational information such as frequently asked question and red
flags included in the app are based on professional guidelines. Moreover, we
refer to professional and reliable information, specifically developed for
Dutch patients (thuisarts.nl).