Digital Care Programs for Musculoskeletal Health

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Musculoskeletal Diseases
• Intervention / Treatment: Device: Acute and post-acute; Device: Chronic; Device: Post-surgical

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

• Study Type: Observational
• Enrollment (Anticipated): 300000

Contacts and Locations

Study Locations

• United States
  • Utah
    • Draper, Utah, United States, 84020
      • SWORD Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Musculoskeletal disorder

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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 Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	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?")	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

Collaborators and Investigators

• Sponsor: Sword Health, SA
• Investigators: Principal Investigator: Fernando D Correia, MD, PhD, SWORD HEALTH INC

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2022
• Primary Completion (Anticipated): July 1, 2027
• Study Completion (Anticipated): April 1, 2032

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: SH-OBS-MSK-US-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Study protocol and study aggregate results (including anonymised individual patient data) will be made available.
• IPD Sharing Time Frame: The data will become available upon studies publication, for 5 years.
• IPD Sharing Access Criteria: Study protocol and the aggregate results will be made available as supplementary information or upon reasonable request upon study publication
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No