An interventional study of Digital program and Conventional physical therapy in Chronic Low-back Pain, sponsored by Sword Health, SA. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Sword Health, SA · Not applicable, Interventional, and Treatment
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.
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 140 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Sword Health, SA is the lead sponsor of 15 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Home-based rehabilitation with a digital biofeedback system
Device: Digital program
Other: Conventional physical therapy
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.
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.
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.
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
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.
Time frame: 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%.
Time frame: 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.
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
Medication Consumption
Change in medication consumption, measured through the following questions: i. "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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
Retention Rate
Number of participants that complete the 8 week program.
Time frame: Between baseline and 8 weeks.
Treatment Intensity
Total number of minutes spent doing exercise sessions.
Time frame: 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%
Time frame: 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%
Time frame: 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%
Time frame: Baseline and 8 weeks after initiation of rehabilitation program
Dropout Rate
Rate of patients who dropout from the program
Time frame: Program-end
Total Sessions
Number of sessions performed at program-end
Time frame: 8 weeks
Frequency of Sessions Per Week
Number of sessions performed per week in the 8-week rehabilitation program
Time frame: 8-weeks
| Milestone | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic |
|---|---|---|
| Started | 70 | 70 |
| Completed | 57 | 45 |
| Not completed | 13 | 25 |
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.
| units on a scale | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic |
|---|---|---|
| Baseline | 24.84 (19.93 to 28.75) | 25.34 (21.91 to 28.77) |
| 8-weeks | 17.94 (6.37 to 19.72) | 18.99 (15.20 to 22.78) |
| Change baseline-8 weeks | -6.90 (-19.33 to -1.57) | -6.35 (-10.36 to -3.83) |
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.
| units on a scale | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic |
|---|---|---|
| Baseline | 5.40 (4.59 to 6.02) | 5.49 (5.05 to 5.94) |
| 8-weeks | 3.59 (2.67 to 4.52) | 3.38 (2.71 to 4.05) |
| Change baseline-8 weeks | -1.81 (-3.51 to -0.25) | -2.11 (-2.82 to -1.49) |
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%.
| units on a scale | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic |
|---|---|---|
| Baseline | 25.61 (13.81 to 30.80) | 23.79 (18.84 to 28.74) |
| 8-weeks | 16.87 (0.00 to 18.98) | 17.67 (10.29 to 25.05) |
| Change baseline-8 weeks | -8.74 (-25.98 to -2.72) | -6.12 (-9.25 to 4.97) |
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.
| units on a scale | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic |
|---|---|---|
| Baseline | 6.43 (0.00 to 20.68) | 9.76 (4.88 to 14.64) |
| 8-weeks | 0.06 (0.00 to 1.49) | 0.06 (0.00 to 4.77) |
| Change baseline-8 weeks | -6.37 (-25.06 to -2.92) | -9.69 (-13.60 to -4.38) |
Change in medication consumption, measured through the following questions: i. "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.
| Participants | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic |
|---|---|---|
| Medication Consumption | 9 | 7 |
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.
| units on a scale | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic |
|---|---|---|
| Baseline | 14.41 (12.06 to 14.78) | 13.99 (12.50 to 15.48) |
| 8-weeks | 12.48 (8.41 to 12.71) | 12.48 (10.65 to 14.32) |
| Change baseline-8 weeks | -1.92 (-5.48 to 2.48) | -1.50 (-3.28 to 0.03) |
Change in the General Anxiety Disorder-7 scale score. Minimum score zero; maximum score 21. Lower scores indicate less severe anxiety.
| units on a scale | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic |
|---|---|---|
| Baseline | 3.79 (1.32 to 5.88) | 4.22 (2.92 to 5.51) |
| 8-weeks | 2.51 (0.00 to 2.72) | 2.51 (1.36 to 3.67) |
| Change baseline-8 weeks | -1.28 (-4.35 to -0.91) | -1.70 (-2.16 to -0.30) |
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.
| units on a scale | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic |
|---|---|---|
| Patient Satisfaction With Intervention | 8.4 ± 2.0 | 8.4 ± 2.6 |
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.
| Participants | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic |
|---|---|---|
| Baseline — High | 17 | 14 |
| Baseline — Moderate | 19 | 16 |
| Baseline — Low | 21 | 15 |
| 8-weeks — High | 23 | 17 |
| 8-weeks — Moderate | 20 | 15 |
| 8-weeks — Low | 14 | 13 |
Change in the Patient Health Questionnaire 9 - 7 scale score. Minimum score zero; maximum score 27. Lower scores indicate less severe depression.
| units on a scale | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic |
|---|---|---|
| Baseline | 4.09 (0.45 to 4.87) | 4.67 (3.54 to 5.80) |
| 8-weeks | 3.22 (1.05 to 3.67) | 2.48 (1.44 to 3.52) |
| Change baseline-8-weeks | -0.87 (-4.43 to -0.51) | -2.19 (-2.86 to -1.14) |
Number of participants that complete the 8 week program.
| Participants | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic |
|---|---|---|
| Retention Rate | 57 | 45 |
Total number of minutes spent doing exercise sessions.
| minutes | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic |
|---|---|---|
| Treatment Intensity | 451.78 ± 227.36 | 385.98 ± 145.36 |
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%
| units on a scale | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic |
|---|---|---|
| Baseline | 23.52 (11.32 to 29.49) | 22.51 (17.62 to 27.40) |
| 8-weeks | 15.33 (0.00 to 17.62) | 16.29 (8.86 to 23.73) |
| Change baseline-8 weeks | -8.19 (-22.87 to 0.03) | -6.22 (-10.14 to 2.68) |
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%
| units on a scale | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic |
|---|---|---|
| Baseline | 3.35 (0.00 to 13.08) | 2.63 (0.29 to 4.96) |
| 8-weeks | 0.00 (0.00 to 13.08) | 0.00 (0.00 to 2.34) |
| Change baseline-8 weeks | -3.36 (-9.01 to -1.51) | -2.63 (-4.38 to -1.99) |
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%
| units on a scale | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic |
|---|---|---|
| Baseline | 35.59 (27.39 to 44.10) | 36.73 (29.60 to 43.87) |
| 8-week | 22.66 (1.11 to 28.34) | 23.45 (17.22 to 29.69) |
| Change baseline-8 weeks | -12.93 (-32.09 to -3.11) | -13.28 (-19.27 to -7.38) |
Rate of patients who dropout from the program
| Participants | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic |
|---|---|---|
| Dropout Rate | 11 | 24 |
Number of sessions performed at program-end
| sessions | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic |
|---|---|---|
| Total Sessions | 22.32 ± 9.46 | 12.42 ± 4.95 |
Number of sessions performed per week in the 8-week rehabilitation program
| sessions per week | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic |
|---|---|---|
| Frequency of Sessions Per Week | 2.79 ± 1.18 | 1.55 ± 0.62 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Digital Rehabilitation | 0/63 (0%) | 0/63 (0%) | 11/63 (17.5%) |
| Conventional Rehabilitation at an Outpatient Clinic | 0/57 (0%) | 0/57 (0%) | 6/57 (10.5%) |
| Event | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic |
|---|---|---|
| Low Back PainMusculoskeletal and connective tissue disorders | 1/63 | 2/57 |
| FallInjury, poisoning and procedural complications | 2/63 | 1/57 |
| Ankle SprainMusculoskeletal and connective tissue disorders | 0/63 | 1/57 |
| Struck by CarSocial circumstances | 0/63 | 1/57 |
| Cold sicknessInfections and infestations | 0/63 | 1/57 |
| Brain BleedingVascular disorders | 1/63 | 0/57 |
| Spine ProcedureMusculoskeletal and connective tissue disorders | 1/63 | 0/57 |
| Chest PainGeneral disorders | 1/63 | 0/57 |
| Knee PainMusculoskeletal and connective tissue disorders | 1/63 | 0/57 |
| Covid-19 infectionInfections and infestations | 1/63 | 0/57 |
| Age, Continuous(years) | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic | Total |
|---|---|---|---|
| Median | 50.50 (39.25 to 61.50) | 54.50 (43.00 to 63.25) | 52.00 (40.00 to 63.00) |
| Age, Customized(Participants) | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic | Total |
|---|---|---|---|
| <25 | 1 | 4 | 5 |
| 25-40 | 21 | 10 | 31 |
| 41-60 | 30 | 31 | 61 |
| >60 | 18 | 25 | 43 |
| Sex: Female, Male(Participants) | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic | Total |
|---|---|---|---|
| Female | 46 | 49 | 95 |
| Male | 24 | 21 | 45 |
| Race/Ethnicity, Customized(Participants) | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic | Total |
|---|---|---|---|
| Asian or Pacific Islander | 11 | 6 | 17 |
| Black or African American | 27 | 34 | 61 |
| Hispanic or Latino | 3 | 2 | 5 |
| Native American or Alaskan Native | 0 | 1 | 1 |
| White or Caucasian | 28 | 23 | 51 |
| Multi-racial or biracial | 0 | 2 | 2 |
| Prefer not to answer | 1 | 2 | 3 |
| Education level(Participants) | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic | Total |
|---|---|---|---|
| Did not attend school | 0 | 1 | 1 |
| Some high school | 2 | 2 | 4 |
| High school graduate or GED | 7 | 5 | 12 |
| Some colleges (some community colleges, associate degree) | 17 | 19 | 36 |
| Four-year college degree or bachelor's degree | 17 | 14 | 31 |
| Some postgraduate or professional schooling, no postgraduate degree | 4 | 6 | 10 |
| Postgraduate or professional degree (including master's, doctorate, medical or law degree) | 23 | 22 | 45 |
| Prefer not to answer | 0 | 1 | 1 |
| Body Mass Index, categories(Participants) | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic | Total |
|---|---|---|---|
| Normal (18.5-25) | 21 | 21 | 42 |
| Overweight (>25-30) | 21 | 22 | 43 |
| Obese (>30-40) | 23 | 21 | 44 |
| Morbidly obese (>40) | 5 | 6 | 11 |
| Employment status(Participants) | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic | Total |
|---|---|---|---|
| Employed (part-time or fulltime) | 48 | 46 | 94 |
| Unemployed (seeking opportunities) | 7 | 4 | 11 |
| Not employed and not seeking work | 14 | 18 | 32 |
| Prefer not to answer | 1 | 2 | 3 |
| Exercise levels(Participants) | Digital Rehabilitation | Conventional Rehabilitation at an Outpatient Clinic | Total |
|---|---|---|---|
| None | 10 | 14 | 24 |
| Less than 1 h | 20 | 13 | 33 |
| Between 1-2.5 h | 18 | 24 | 42 |
| >2.5 h | 22 | 19 | 41 |
12 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Sword Health, SA