Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04401683 |
| Other study ID # |
SH-RCT-LBP-01 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 25, 2021 |
| Est. completion date |
July 1, 2022 |
Study information
| Verified date |
March 2021 |
| Source |
Sword Health, SA |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The present study is a a single-center, prospective, non-blind, parallel-group, randomized
controlled trial, designed to evaluate the clinical impact of a home-based program using a
new digital solution on the treatment of non-specific chronic low back pain (CLBP) in adults
versus standard of care.
The hypothesis is that all the clinical outcomes measured will significantly improve after
the program, and patients using this novel system will attain better outcomes than the ones
in the standard of care group.
This evidence-based digital program developed by SWORD Health is built on three main pillars
- therapeutic exercise, education and cognitive-behavioural therapy, and is specifically
tailored to address CLBP. The program will be delivered directly at patient's home, using a
biofeedback system and continuous personalised remote clinical monitoring.
Description:
Low back pain (LBP) has for long been the world's leading cause of years leaved with
disability, 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, and behavioural therapy as the mainstays 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. Importantly, however, the main driver of the direct cost component in the care of
LBP is physical therapy, meaning new ways of delivering therapy are warranted.
Besides exercise therapy, 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
non-opioid alternatives for CLBP is of paramount importance.
Thus, SWORD Health has developed an evidence-based program for this disorder based on two
main pillars - patient education and therapeutic exercise - the latter delivered through our
digital therapist, directly at the patient´s home, and with continuous clinical supervision.
This approach has already demonstrated to be feasible, safe and to lead to better outcomes
than conventional home-based rehabilitation after joint replacement. These results were
explained by (a) the positive impact of a kinematic biofeedback tool on patient performance,
especially regarding error correction and stimulation of a greater range of motion; (b)
patient empowerment regarding their rehabilitation process; (c) high patient engagement
through the use of gamification strategies; (d) the positive effect of remote monitoring on
patient effort and (e) the availability of objective data for clinical review, enabling
data-driven decisions.
The present study is a a single-center, prospective, non-blind, parallel-group, randomized
controlled trial, designed to evaluate the clinical impact of a home-based program using a
new digital solution on the treatment of non-specific CLBP in adults versus standard of care.
The hypothesis is that all the clinical outcomes measured will significantly improve after
the program, and patients using this novel system will attain better outcomes than the ones
in the standard of care group.
