Digital Care Programs for Musculoskeletal Health

Официальное название

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

Обзор

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).

Подробное описание

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

Вмешательства

• Устройство 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.
• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Self-reported Pain (NPRS) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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]

Вторичные конечные точки (7)

• Self-reported Pain (VAS) [Срок оценки: Baseline and following each exercise session through program completion, an average of 40 sessions]
• Self-reported fatigue (VAS) [Срок оценки: Baseline and following each exercise session until the end of the program]
• Self-reported Surgical intent [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Sword Health — Draper

Публикации

• 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. PMID 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. PMID 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. PMID 39470695

Идентификаторы

NCT: NCT05417685 · SH-OBS-MSK-US-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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