Digital Care Programs for Musculoskeletal Health

• Conditions: Musculoskeletal Diseases
• Interventions: Device: Acute and post-acute; Device: Chronic; Device: Post-surgical

• Registration Number: NCT05417685
• Lead Sponsor: Sword Health, SA

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).

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 Timeline

• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-06-09
• Study First Posted: 2022-06-14
• Study Start: 2022-07-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-06
• Primary Completion: 2027-07-01
• Study Completion: 2032-04-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 300000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Musculoskeletal disorder	Chronic	-
Musculoskeletal disorder	Post-surgical	-
Musculoskeletal disorder	Acute and post-acute	-

Primary Outcome Measures

Name	Time	Method
Short form of Foot and Ankle Ability Measure (QuickFAAM)	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 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.
Short version of the Disabilities of the Arm, Shoulder and Hand questionnaire	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 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).
Short form Knee Osteoarthritis Outcomes score (KOOS-PS)	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 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.
Neck Disability Index (NDI)	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 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%
Self-reported Pain (NPRS)	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 Pain Numerical Rating Scale
Short form Hip Osteoarthritis Outcomes Score (HOOS-PS)	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 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.
Neck, lower spine, shoulder, elbow, ankle, hip and knee range of motion (ROM)	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 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.
Oswestry Disability Index (ODI)	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 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.
Fear avoidance behaviour	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 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).

Secondary Outcome Measures

Name	Time	Method
Self-reported Pain (VAS)	Baseline and following each exercise session through program completion, an average of 40 sessions	Change over time in clinical outcomes common to all conditions measured through a 0-10 Visual Analogue Scale for pain
Self-reported fatigue (VAS)	Baseline and following each exercise session until the end of the program	Change over time in clinical outcomes common to all conditions measured through a 0-10 Visual Analogue Scale for fatigue
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	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)
Work productivity and absenteeism	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 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%)
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	Change over time in clinical outcomes common to all conditions measured through Numerical rating scale (0-100)
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	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)
Depression	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 Patient Health Questionnaire-9 (PHQ-9) is a 9-item scale (0-27)

Trial Locations

Locations (1)

Sword Health; 🇺🇸 Draper, Utah, United States