Clinical trial NCT04808141: Digital Care Program for Chronic Low Back Pain
Official title: Digital Care Program for Chronic Low Back Pain Versus Conventional Physical Therapy: a Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Lead sponsor: Sword Health, SA
Sponsor class: INDUSTRY
Collaborators: name: Emory University
First posted: 2021-03-22
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: TREATMENT

Brief summary: New ways of delivering care are much needed to address chronic low back pain. Crucially, these need to: a) address the three pillars of care to achieve good and sustained clinical outcomes; b) overcome barriers to access; c) ensure patients are engaged throughout the programs; d) be scalable and cost-efficient. SWORD Health has developed a digital care program to address these needs. This study aims to assess the clinical outcomes of this rehabilitation program versus conventional physical therapy.

Detailed description: Low back pain (LBP) has for long been the world's leading cause of years leaved with disability,1 and, considering that the overall life expectancy is rising, this pandemic only tends to get worse. Nearly everyone is affected by LBP at some moment in life (70-80% of lifetime prevalence). As a consequence, LBP is also presented as a leading cause of work absenteeism worldwide. Thus, although the estimate costs of LBP may be difficult to compare between different countries, its overwhelming socio-economic impact in modern society is evident.

In the absence of an effective treatment, LBP can become chronic, causing a huge impact in patients' daily life, and ultimately promoting a high consumption of healthcare resources. In the US alone, health expenditures for adults with spinal problems were estimated at $6000 per person, representing a total cost of $102 billion each year.

The dim picture described above highlights the urgent need for effective interventions that minimize disability, improve quality of life and decrease productivity losses.

Current guidelines on CLBP management recommend patient education, exercise, physical therapy (PT), and behavioural therapy as the mainstay treatments for this condition.

Despite some discrepancy in the type of exercise program (e.g. aquatic exercises, stretching, back schools, McKenzie exercise approach, yoga, tai-chi) and mode of delivery (e.g., individually designed programs, supervised home exercise, and group exercise), exercise therapy is recommended nearly transversally, with most studies concluding that exercise intervention programs should include a combination of muscular strength, flexibility and aerobic fitness exercises. Moreover, home exercises with a regular therapist follow-up has proven highly effective.

This is not, however, how LBP is currently managed. Appropriate patient education and structured behavioural training are rarely provided, and opioid prescription is also a common practice, despite known opioid-related morbidity and mortality rates. Because the prevalence of CLBP is continuously rising, and opioid misuse is an issue of great concern globally, identifying effective nonopioid alternatives for CLBP is of paramount importance.

Further compounding this problem, from the patients who are directed to PT, almost half give up after just 4 sessions, and only 30% complete their programs.

In this context, new ways of delivering care are much needed. Crucially, these need to: a) address the three pillars of care to achieve good and sustained clinical outcomes; b) overcome barriers to access; c) ensure patients are engaged throughout the programs; d) be scalable and cost-efficient.

This study aims to assess the clinical outcomes of a digital program for chronic low back pain versus conventional PT.

Eligibility criteria: Inclusion Criteria:

* Subjects aged between 18 and 80 years of age at enrolment
* Reporting intermittent or persistent low back pain for at least 12 weeks, and/or present at least 50% of the time in the past 6 months
* Ability to understand complex motor tasks

Exclusion Criteria:

* Known pregnancy
* Submitted to spinal surgery less than 3 months ago
* Symptoms and/or signs indicative of possible infectious disorder
* Known disorder with indication for spine surgery (i.e., tumor, cauda equina syndrome)
* Cancer diagnosis or undergoing treatment for cancer
* Cardiac, respiratory or other known disorder incompatible with at least 20 minutes of light to moderate physical activity
* Concomitant neurological disorder (e.g. Stroke, multiple sclerosis, Parkinson's disease)
* Dementia or psychiatric disorders precluding patient from complying with a home-based exercise program
* Illiteracy and/or serious visual or auditory impairment interfering with communication or compliance

Primary outcomes:
measure: Oswestry Disability Index Score (ODI)
timeFrame: Baseline and 8 weeks after initiation of rehabilitation program
Secondary outcomes:
measure: Pain Level
timeFrame: Baseline and 8 weeks after initiation of rehabilitation program
measure: Work Productivity and Activity Impairment (WPAI) Overall
timeFrame: Baseline and 8 weeks after initiation of rehabilitation program
measure: Interest in Undergoing Surgery
timeFrame: Baseline and 8 weeks after initiation of rehabilitation program
measure: Medication Consumption
timeFrame: Baseline and 8 weeks after initiation of rehabilitation program
measure: Fear Avoidance Beliefs - Physical Activity (FABQ-PA)
timeFrame: Baseline and 8 weeks after initiation of rehabilitation program
measure: Anxiety
timeFrame: Baseline and 8 weeks after initiation of rehabilitation program
measure: Patient Satisfaction With Intervention
timeFrame: 8 weeks after initiation of rehabilitation program.
measure: Physical Activity Levels
timeFrame: Baseline and 8 weeks after initiation of rehabilitation program
measure: Depression
timeFrame: Baseline and 8 weeks after initiation of rehabilitation program
measure: Retention Rate
timeFrame: Between baseline and 8 weeks.
measure: Treatment Intensity
timeFrame: Between baseline and 8 weeks.
measure: Work Productivity and Activity Impairment (WPAI) Work
timeFrame: Baseline and 8 weeks after initiation of rehabilitation program
measure: Work Productivity and Activity Impairment (WPAI) Time
timeFrame: Baseline and 8 weeks after initiation of rehabilitation program
measure: Work Productivity and Activity Impairment (WPAI) Activity
timeFrame: Baseline and 8 weeks after initiation of rehabilitation program
measure: Dropout Rate
timeFrame: Program-end
measure: Total Sessions
timeFrame: 8 weeks
measure: Frequency of Sessions Per Week
timeFrame: 8-weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Orthopaedic and Spine Center (Atlanta, Ga)
state: Georgia
Study officials:
affiliation: Emory University
name: Cui Di, MD
role: PRINCIPAL_INVESTIGATOR
References: