Chronic Low-back PainNCT04808141
Digital Care Program for Chronic Low Back Pain
A study testing Digital program and Conventional physical therapy in people with Chronic Low-back Pain, run by Sword Health, SA at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Digital program and Conventional physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2021to 5 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory Orthopaedic and Spine Center (Atlanta, Ga)
Atlanta, Georgia, 30324
About this study
Official title: Digital Care Program for Chronic Low Back Pain Versus Conventional Physical Therapy: a Prospective, Randomized Controlled Study
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.
Read the 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.
- Conditions
- Chronic Low-back Pain
- Being tested
- Digital program, Conventional physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital programDevice
Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health. These patients will be referred to SWORD Health by the investigator who identified the candidate. SWORD Health will then assign a physical therapist to each patient. The physical therapist will contact the patient for onboarding and will manage the case.
Conventional physical therapyOther
Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program will follow the protocol outlined in Annex 3, which can however be adapted by the physical therapist to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions.
| Study group | Role | What they receive |
|---|---|---|
| Digital Rehabilitation | Experimental | Home-based rehabilitation with a digital biofeedback system Receives: Device: Digital program |
| Conventional rehabilitation at an outpatient clinic | Active comparator | Not described Receives: Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index Score (ODI)
The minimum value of the score is 0% and the maximum is 100%, with lower scores translating into lower disability. In this study, we will be assessing the change between baseline and 8 weeks in Oswestry Disability Index score.
Measured: Baseline and 8 weeks after initiation of rehabilitation program
Secondary outcomes (17)
Pain Level
Change in pain level Measured through the following question: "On a scale of 0 to 10, where 0 is no pain and 10 the worst pain imaginable, how would you rate your pain in the last 24 hours?" Minimum and maximum values of the scale are respectively 0 and 10, with lower values representing less pain.
Measured: Baseline and 8 weeks after initiation of rehabilitation program
Work Productivity and Activity Impairment (WPAI) Overall
Change in WPAI overall scores. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, with a minimum of 0% and a maximum of 100%.
Measured: Baseline and 8 weeks after initiation of rehabilitation program
Interest in Undergoing Surgery
Change in surgery intent measured through the following question: "On a scale of 0 to 10, where 0 is not at all and 10 is extremely interested, how interested are you in undergoing back surgery in the next 12 months"? Minimum and maximum values of the scale are respectively 0 and 10, with lower values representing a lower interest.
Measured: Baseline and 8 weeks after initiation of rehabilitation program
Medication Consumption
Change in medication consumption, measured through the following questions:
- "Are you taking any medication for your low back pain?"; binary score ii. "If yes, are you taking opioids for your low back pain?"; binary score iii. "If yes, on how many days in a week, on average, are you taking medication for your low back pain" minimum 0; max 7 days, with 7 being worse.
Measured: Baseline and 8 weeks after initiation of rehabilitation program
Fear Avoidance Beliefs - Physical Activity (FABQ-PA)
Change in Fear avoidance beliefs-Physical Activity questionnaire - Physical Activity subscale. The questionnaire consists of 4 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 24 and a minimum score of 0. Lower scores mean lower fear avoidance.
Measured: Baseline and 8 weeks after initiation of rehabilitation program
Anxiety
Change in the General Anxiety Disorder-7 scale score. Minimum score zero; maximum score 21. Lower scores indicate less severe anxiety.
Measured: Baseline and 8 weeks after initiation of rehabilitation program
Patient Satisfaction With Intervention
Measured through the following question: "On a scale from 0 to 10, how likely would you recommend this program to a friend or colleague?". Minimum value is zero and maximum is 10. Higher scores translate higher satisfaction.
Measured: 8 weeks after initiation of rehabilitation program.
Physical Activity Levels
Change in the International Physical Activity Questionnaire- Short Form. The scale scores are calculated to provide a qualitative score: low, moderate and high with higher scores translating into higher activity levels.
Measured: Baseline and 8 weeks after initiation of rehabilitation program
Depression
Change in the Patient Health Questionnaire 9 - 7 scale score. Minimum score zero; maximum score 27. Lower scores indicate less severe depression.
Measured: Baseline and 8 weeks after initiation of rehabilitation program
Retention Rate
Number of participants that complete the 8 week program.
Measured: Between baseline and 8 weeks.
Treatment Intensity
Total number of minutes spent doing exercise sessions.
Measured: Between baseline and 8 weeks.
Work Productivity and Activity Impairment (WPAI) Work
Change in WPAI work scores. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, with a minimum of 0% and a maximum of 100%
Measured: Baseline and 8 weeks after initiation of rehabilitation program
Work Productivity and Activity Impairment (WPAI) Time
Change in WPAI time scores. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, with a minimum of 0% and a maximum of 100%
Measured: Baseline and 8 weeks after initiation of rehabilitation program
Work Productivity and Activity Impairment (WPAI) Activity
Change in WPAI Activity scores. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, with a minimum of 0% and a maximum of 100%
Measured: Baseline and 8 weeks after initiation of rehabilitation program
Dropout Rate
Rate of patients who dropout from the program
Measured: Program-end
Total Sessions
Number of sessions performed at program-end
Measured: 8 weeks
Frequency of Sessions Per Week
Number of sessions performed per week in the 8-week rehabilitation program
Measured: 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start25 May 2021
- Primary completion16 Nov 2022
- Study completion5 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sword Health, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emory University
- Responsible party
- Sponsor
- Investigators
- Cui Di, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808141
- Sponsor's protocol ID
- SH-RCT-LBP-US-01
- Status last verified
- May 2025
- First submitted
- 12 Mar 2021
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The study protocol will be made available in PDF format. Aggregate study results, with anonymised individual participant data will be made available in Excel format
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Care Program for Chronic Low Back Pain Versus Conventional Physical Therapy: a Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04808141
- Acronym / sponsor ID
- SH-RCT-LBP-US-01
- Conditions
- Chronic Low-back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Sword Health, SAIndustry (pharma, biotech, devices)
- Collaborators
- Emory University
- Study start
- 25 May 2021 (actual)
- Primary completion
- 16 Nov 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Posted 16 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Digital Rehabilitation | Experimental | Device: Digital programHome-based rehabilitation with a digital biofeedback system |
| Conventional rehabilitation at an outpatient clinic | Active comparator | Other: Conventional physical therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital programPatients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health. These patients will be referred to SWORD Health by the investigator who identified the candidate. SWORD Health will then assign a physical therapist to each patient. The physical therapist will contact the patient for onboarding and will manage the case. | Device | Digital Rehabilitation |
| Conventional physical therapyPatients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program will follow the protocol outlined in Annex 3, which can however be adapted by the physical therapist to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions. | Other | Conventional rehabilitation at an outpatient clinic |
Primary outcome
Oswestry Disability Index Score (ODI)
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
The minimum value of the score is 0% and the maximum is 100%, with lower scores translating into lower disability. In this study, we will be assessing the change between baseline and 8 weeks in Oswestry Disability Index score.
17 secondary outcomes
Pain Level
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
Work Productivity and Activity Impairment (WPAI) Overall
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
Interest in Undergoing Surgery
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
Medication Consumption
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
Fear Avoidance Beliefs - Physical Activity (FABQ-PA)
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
Anxiety
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
Patient Satisfaction With Intervention
Time frame: 8 weeks after initiation of rehabilitation program.
Physical Activity Levels
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
Depression
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
Retention Rate
Time frame: Between baseline and 8 weeks.
Treatment Intensity
Time frame: Between baseline and 8 weeks.
Work Productivity and Activity Impairment (WPAI) Work
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
Work Productivity and Activity Impairment (WPAI) Time
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
Work Productivity and Activity Impairment (WPAI) Activity
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
Dropout Rate
Time frame: Program-end
Total Sessions
Time frame: 8 weeks
Frequency of Sessions Per Week
Time frame: 8-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The study protocol will be made available in PDF format. Aggregate study results, with anonymised individual participant data will be made available in Excel format
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cui Di, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital program and Conventional physical therapy in people with Chronic Low-back Pain, run by Sword Health, SA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index Score (ODI) (time frame: Baseline and 8 weeks after initiation of rehabilitation program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.