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Musculoskeletal DiseasesNCT05417685

Digital Care Programs for Musculoskeletal Health

An observational study of Musculoskeletal Diseases, run by Sword Health, SA at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Musculoskeletal Diseases
What is being tested?
Acute and post-acute, Chronic and Post-surgical
Type of treatment
Medical device
How many people
300,000 participants
Where
1 siteUnited States
Study dates
26 Jul 2022to 1 Apr 2032
How long will I take part?
2 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • Over 18 years old;
  • Acute (<12 weeks) or chronic (>12 weeks) musculoskeletal pain involving any of the following body areas: neck, upper and lower back, shoulder, elbow, wrist/hand, hip, knee, ankle OR Recovering from MSK surgery involving the above body areas with indication from their surgeon to engage in a physical therapy program
  • Able to understand study procedures and willing to provide informed consent.

Who cannot join

  • Health condition (cardiac, respiratory, neurological, immune) condition incompatible with at least 20 minutes of light to moderate exercise if not cleared by a physician to engage in an exercise program
  • Rapidly progressive and new in onset neurological complaints if not cleared by a physician to engage in an exercise program
  • Active cancer diagnosis or receiving treatment for cancer if not cleared by a physician to engage in an exercise program
  • Significant trauma to the area of pain within the last 12 weeks and functional incapacity and not cleared by a physician to engage in an exercise program
  • MSK surgery within the last 12 weeks and not cleared by a physician to engage in an exercise program

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Sword Health

    Draper, Utah, 84020

Other trials in United States

About this study

Official title: Digital Care Programs for Musculoskeletal Health: a Large-scale, Multi-disorder, Observational Study

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).

Read the detailed description

This scientific research was designed to:

  • Assess the adoption, engagement and feasibility of digital care programs for musculoskeletal conditions and musculoskeletal health
  • Assess the results of digital care programs and compare the costs with the benefits obtained;
  • Increase the knowledge on several musculoskeletal conditions, namely how they progress and respond to digital care programs;
  • Develop new or improved tools to assist clinicians in the management of these conditions and in helping people achieve better musculoskeletal health

Collection and objective analysis of the collected data will allow:

  1. Assess the adoption, engagement and feasibility of digital care programs for musculoskeletal conditions and musculoskeletal health
  2. Assess the results of digital care programs and compare the costs with the benefits obtained;
  3. Correlate the results with patient's demographic and clinical profiles;
  4. Examine the impact of mental health and the behavioral modification components of SWORD Health interventions on disease markers, comorbidities, and productivity;
  5. Increase the knowledge on several musculoskeletal conditions, namely how they progress and respond to digital care programs;
  6. Develop new or improved tools to assist clinicians in the management of these conditions and in helping people achieve better musculoskeletal health

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

Being tested
Acute and post-acute, Chronic, Post-surgical
Medical subject headings
Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acute and post-acuteDevice

    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.

  • ChronicDevice

    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-surgicalDevice

    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.

Study groups in NCT05417685
Study groupRoleWhat they receive
Musculoskeletal disorderNot described
Receives: Device: Acute and post-acute; Device: Chronic; Device: Post-surgical

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-reported Pain (NPRS)

    Change over time in clinical outcomes common to all conditions measured through a 0-10 Pain Numerical Rating Scale

    Measured: 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

  2. 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).

    Measured: 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

  3. 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.

    Measured: 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

  4. 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%

    Measured: 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

  5. 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.

    Measured: 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

  6. 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.

    Measured: 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

  7. 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.

    Measured: 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

  8. 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).

    Measured: 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

  9. 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.

    Measured: 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

Secondary outcomes (7)

  1. Self-reported Pain (VAS)

    Change over time in clinical outcomes common to all conditions measured through a 0-10 Visual Analogue Scale for pain

    Measured: Baseline and following each exercise session through program completion, an average of 40 sessions

  2. Self-reported fatigue (VAS)

    Change over time in clinical outcomes common to all conditions measured through a 0-10 Visual Analogue Scale for fatigue

    Measured: Baseline and following each exercise session until the end of the program

  3. Self-reported Surgical intent

    Change over time in clinical outcomes common to all conditions measured through Numerical rating scale (0-100)

    Measured: 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

  4. 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)

    Measured: 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

  5. 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)

    Measured: 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

  6. 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)

    Measured: 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

  7. 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%)

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2022
  2. Study start26 Jul 2022
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Apr 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300,000 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05417685
Sponsor's protocol ID
SH-OBS-MSK-US-01
Status last verified
Dec 2024
First submitted
6 Jun 2022
Last updated
6 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study protocol and study aggregate results (including anonymised individual patient data) will be made available.

Publications

  • 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 Jul 1;27(7):828-838. doi: 10.1093/pm/pnag019.

    PubMed 41629208

  • 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.

    PubMed 39561359

  • 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.

    PubMed 39470695

Questions about this trial

What is this clinical trial studying?

An observational study of Musculoskeletal Diseases, 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 5 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: enrolling by invitation, as of the sponsor's last update on 6 Dec 2024. 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?

This study is still under way. Results are not available in the source record yet.

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?

Self-reported Pain (NPRS) (time frame: 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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05417685, which also lists 3 linked publications.

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 6 Dec 2024.

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