Digital Care Programs for Musculoskeletal Health

NCT05417685 | Enrolling By Invitation

• 1 other identifier: SH-OBS-MSK-US-01
• Study Type: observational
• Target: 300,000
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Musculoskeletal Diseases

Outcome Measures

Primary Outcomes (9)

• 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

• 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

Secondary Outcomes (7)

• Self-reported Pain (VAS)

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

• Self-reported fatigue (VAS)

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

• Self-reported Surgical intent

  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

  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

  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

Other Outcomes (4)

• Sessions performed

  Measured at the end of the program, an average of 12 weeks

• Self-reported satisfaction

  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

  Measured at the end of the program, an average of 12 weeks

Study Arms (1)

Musculoskeletal disorder

Device: Acute and post-acute; Device: Chronic; Device: Post-surgical

Interventions

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.

Musculoskeletal disorder

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.

Musculoskeletal disorder

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.

Musculoskeletal disorder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sword Health, SA: lead

Study Sites (1)

Sword Health

Draper, Utah, 84020, United States

Location

Related Publications (3)

• 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.

  PMID: 41629208 DERIVED

• 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.

  PMID: 39561359 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.

  PMID: 39470695 DERIVED

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Subacute Care

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Fernando D Correia, MD, PhD

  SWORD HEALTH INC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 14, 2022
• Study Start: July 26, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): April 1, 2032
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will become available upon studies publication, for 5 years.
• Access Criteria: Study protocol and the aggregate results will be made available as supplementary information or upon reasonable request upon study publication

Locations

US (1)