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The purpose of this study is to create a research repository, composed of data collected in the course of digital care programs for musculoskeletal conditions and musculoskeletal health delivered by SWORD Health to individuals undergoing those programs.
This will allow the investigators to observe the acceptance, engagement and outcomes of programs using this approach in the treatment of multiple musculoskeletal disorders (MSD).
This scientific research was designed to:
Collection and objective analysis of the collected data will allow:
Clinical outcomes
The primary outcome will be the evolution of patient's clinical condition along the rehabilitation program, objectively estimated through the monitoring data collected using SWORD Phoenix®, as part of patients' supervision routine. Depending on the condition, primary and secondary outcome measures vary.
In any case, this registry will include a complete characterisation of the clinical condition, as well as the periodic assessment of: a) joints' range of motion (collect by the medical device); b) performance indicators (through condition-specific tests); c) patient-reported outcomes (obtained using internationally validated pathology-specific questionnaires); d) pain and fatigue levels (reported by patients by the end of each therapeutic exercise session); e) compliance; f) patient satisfaction
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Musculoskeletal disorder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acute and post-acute | Device | These programs will cover patients suffering from acute or post-acute musculoskeletal conditions including, but not limited to, shoulder pain (tendinitis/impingement/bursitis), neck pain, low back pain, knee or hip pain/osteoarthritis, which significantly impact their quality of life, to the extent they seek specialised care in direct relation to these disorders. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Pain (NPRS) | Change over time in clinical outcomes common to all conditions measured through a 0-10 Pain Numerical Rating Scale | Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Short version of the Disabilities of the Arm, Shoulder and Hand questionnaire | Change in condition-specific clinical outcomes over time measured through the short version of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH). Scoring Formula = ([(sum of n responses)/n] -1)x(25). | Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Oswestry Disability Index (ODI) | Change in condition-specific clinical outcomes over time measured through the Oswestry Disability Index (ODI). \ The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible. | Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Neck Disability Index (NDI) | Change in condition-specific clinical outcomes over time measured through the Neck Disability Index (NDI). For each section the total possible score is 5: if the first statement is marked the section score = 0, if the last statement is marked it = 5. If all ten sections are completed the score is calculated as follows: Example:16 (total scored) 50 (total possible score) x 100 = 32% | Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Pain (VAS) | Change over time in clinical outcomes common to all conditions measured through a 0-10 Visual Analogue Scale for pain | Baseline and following each exercise session through program completion, an average of 40 sessions |
| Self-reported fatigue (VAS) |
| Measure | Description | Time Frame |
|---|---|---|
| Sessions performed | Number of total exercise sessions performed | Measured at the end of the program, an average of 12 weeks |
| Self-reported satisfaction | measured through the Net Promoter Score question collected at end of program: "On a scale from 0 to 10, how likely are you to recommend SWORD's programs to a friend or family member?") |
Inclusion Criteria:
Exclusion Criteria:
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These programs will cover patients suffering from musculoskeletal conditions including, but not limited to, shoulder pain (tendinitis/impingement/bursitis), neck pain, low back pain, knee or hip pain/osteoarthritis, which, irrespective of their duration (acute, post-acute or chronic), significantly impact their quality of life, to the extent they seek specialized care in direct relation to these disorders. The programs will also cover patients submitted to surgery for a given musculoskeletal condition, including, but not limited to, shoulder tendon repair, shoulder replacement, spinal surgery, hip or knee replacement, meniscal repair, knee ligament reconstruction, undergoing physical rehabilitation programs after surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Fernando D Correia, MD, PhD | SWORD HEALTH INC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sword Health | Draper | Utah | 84020 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41629208 | Derived | Janela D, Tong X, Pires D, Fonseca H, Costa F. Predicting Pain Outcomes after Digital Care in Chronic Spinal Pain: the roles of Disability, Work Impairment, and Occupation in a Secondary Analysis of a Prospective Clinical Study. Pain Med. 2026 Feb 2:pnag019. doi: 10.1093/pm/pnag019. Online ahead of print. | |
| 39561359 | Derived |
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Study protocol and study aggregate results (including anonymised individual patient data) will be made available.
The data will become available upon studies publication, for 5 years.
Study protocol and the aggregate results will be made available as supplementary information or upon reasonable request upon study publication
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| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019467 | Subacute Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Chronic | Device | These programs will cover patients suffering from chronic musculoskeletal conditions including, but not limited to, shoulder pain (tendinitis/impingement/bursitis), neck pain, low back pain, knee or hip pain/osteoarthritis, which significantly impact their quality of life, to the extent they seek specialised care in direct relation to these disorders. |
|
| Post-surgical | Device | These programs will cover patients submitted to surgery for a given musculoskeletal condition, including, but not limited to, shoulder tendon repair, shoulder replacement, spinal surgery, hip or knee replacement, meniscal repair, knee ligament reconstruction, undergoing physical rehabilitation programs after surgery. |
|
| Short form of Foot and Ankle Ability Measure (QuickFAAM) | Change in condition-specific clinical outcomes over time, measured through the short form of Foot and Ankle Ability Measure (QuickFAAM). This is a 12-item scale with 5-likert options, the total number of points are added, divided by the total number os possible points and then multiplied by 100. | Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Short form Hip Osteoarthritis Outcomes Score (HOOS-PS) | Change in condition-specific clinical outcomes over time, measured through the short form Hip Osteoarthritis Outcomes Score (HOOS-PS). This is a 5-item scale with 5-likert options, the total number of points are added, divided by the total number os possible points and then multiplied by 100. | Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Short form Knee Osteoarthritis Outcomes score (KOOS-PS) | Change in condition-specific clinical outcomes over time, measured through the short form Knee Osteoarthritis Outcomes score (KOOS-PS) This is a 7-item scale with 5-likert options, the total number of points are added, divided by the total number os possible points and then multiplied by 100. | Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Fear avoidance behaviour | Change over time in clinical outcomes of low back pain measured through the Fear Avoidance Beliefs Questionnaire - Physical Activity (FABQ - PA). This is a 5-item scale with 6 likert options. The total number of points are added. Maximum score is 30. Higher scores mean higher fear avoidance (higher scores are worse). | Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Neck, lower spine, shoulder, elbow, ankle, hip and knee range of motion (ROM) | Change in condition-specific clinical outcomes over time measured through Neck, lower spine, shoulder, elbow, ankle, hip and knee range of motion (ROM) (flexion/extension/abduction/rotation), in degrees, as directly retrieved from the angle measurement tool integrated within the medical device. | Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
Change over time in clinical outcomes common to all conditions measured through a 0-10 Visual Analogue Scale for fatigue |
| Baseline and following each exercise session until the end of the program |
| Self-reported Surgical intent | Change over time in clinical outcomes common to all conditions measured through Numerical rating scale (0-100) | Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Self-reported consumption of painkillers | Change over time in clinical outcomes common to all conditions measured through Self-reported consumption of painkillers (yes/no; Prescription drugs (yes/no); Opioids intake (yes/no) | Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Anxiety | Change over time in clinical outcomes common to all conditions measured through General Anxiety Disorder-7 (GAD-7) is a 7-item scale (scores 0-21) | Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Depression | Change over time in clinical outcomes common to all conditions measured through Patient Health Questionnaire-9 (PHQ-9) is a 9-item scale (0-27) | Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Work productivity and absenteeism | Change over time in clinical outcomes common to all conditions measured through Work Productivity and Activity Impairment Questionnaire (WPAI) assessed by the sub-scores: WPAI overall (combining presenteeism and absenteeism), WPAI work (presenteeism), WPAI time (absenteeism) and WPAI activities (activities of daily living impairment) (scores 0-100%) | Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Baseline, and then at regular intervals (after 9, 18 and 27 sessions) after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Total treatment time | Number of minutes spent on exercise sessions (aggregated) | Measured at the end of the program, an average of 12 weeks |
| Average treatment time per week | Average number of minutes spent on exercise per week | Measured at the end of the program, an average of 12 weeks |
| C Areias A, G Moulder R, Molinos M, Janela D, Bento V, Moreira C, Yanamadala V, P Cohen S, Dias Correia F, Costa F. Predicting Pain Response to a Remote Musculoskeletal Care Program for Low Back Pain Management: Development of a Prediction Tool. JMIR Med Inform. 2024 Nov 19;12:e64806. doi: 10.2196/64806. |
| 39470695 | Derived | Areias AC, Janela D, Molinos M, Bento V, Moreira C, Yanamadala V, Cohen SP, Correia FD, Costa F. Exploring the Importance of Race and Gender Concordance Between Patients and Physical Therapists in Digital Rehabilitation for Musculoskeletal Conditions: Observational, Longitudinal Study. J Med Internet Res. 2024 Oct 29;26:e65354. doi: 10.2196/65354. |