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Digital Care Program for Chronic Low Back Pain

NCT04808141 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-05-16

Study results available
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Summary

New ways of delivering care are much needed to address chronic low back pain. Crucially, these need to: a) address the three pillars of care to achieve good and sustained clinical outcomes; b) overcome barriers to access; c) ensure patients are engaged throughout the programs; d) be scalable and cost-efficient. SWORD Health has developed a digital care program to address these needs. This study aims to assess the clinical outcomes of this rehabilitation program versus conventional physical therapy.

Conditions

  • Chronic Low-back Pain

Interventions

DEVICE

Digital program

Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health. These patients will be referred to SWORD Health by the investigator who identified the candidate. SWORD Health will then assign a physical therapist to each patient. The physical therapist will contact the patient for onboarding and will manage the case.

OTHER

Conventional physical therapy

Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program will follow the protocol outlined in Annex 3, which can however be adapted by the physical therapist to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions.

Sponsors & Collaborators

  • Emory University

    collaborator OTHER

  • Sword Health, SA

    lead INDUSTRY

Principal Investigators

  • Cui Di, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-25
Primary Completion
2022-11-16
Completion
2022-12-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04808141 on ClinicalTrials.gov