Digital Care Programs for Musculoskeletal Health

SWORD Health

Status: Invitation-only

Conditions: Musculoskeletal Diseases

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

Study type: Observational

Funder types: Industry

Identifiers

NCT05417685

SH-OBS-MSK-US-01

Details and patient eligibility

About

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).

Full 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

Enrollment: 300,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

300,000 participants in 1 patient group

Musculoskeletal disorder

Treatment:

Device: Post-surgical

Device: Acute and post-acute

Device: Chronic