CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 140 enrolled
Drug / intervention
Digital program +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04808141
NCT04808141N/ACompleted

Digital Care Program for Chronic Low Back Pain Versus Conventional Physical Therapy: a Prospective, Randomized Controlled Study

Sword Health, SA·interventional·Posted Mar 22, 2021·Updated May 16, 2025

In Brief

A clinical study evaluating Digital program and Conventional physical therapy for Chronic Low-back Pain. Completed, enrolled 140 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsEmory University

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 22, 2021
Enrollment StartMay 25, 2021
Primary CompletionNov 16, 2022
Study CompletionDec 5, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.3 years ago

Interventions

Digital programdevice

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.

Conventional physical therapyother

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.