Digital Care Program for Chronic Low Back Pain

NCT04808141 | Completed Results FDA Device

• 1 other identifier: SH-RCT-LBP-US-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index Score (ODI)

  The minimum value of the score is 0% and the maximum is 100%, with lower scores translating into lower disability. In this study, we will be assessing the change between baseline and 8 weeks in Oswestry Disability Index score.

  Baseline and 8 weeks after initiation of rehabilitation program

Secondary Outcomes (17)

• Pain Level

  Baseline and 8 weeks after initiation of rehabilitation program

• Work Productivity and Activity Impairment (WPAI) Overall

  Baseline and 8 weeks after initiation of rehabilitation program

• Interest in Undergoing Surgery

  Baseline and 8 weeks after initiation of rehabilitation program

• Medication Consumption

  Baseline and 8 weeks after initiation of rehabilitation program

• Fear Avoidance Beliefs - Physical Activity (FABQ-PA)

  Baseline and 8 weeks after initiation of rehabilitation program

Study Arms (2)

Digital Rehabilitation

EXPERIMENTAL

Home-based rehabilitation with a digital biofeedback system

Device: Digital program

Conventional rehabilitation at an outpatient clinic

ACTIVE COMPARATOR

Other: Conventional physical therapy

Interventions

Digital program DEVICE

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.

Digital Rehabilitation

Conventional physical therapy OTHER

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.

Conventional rehabilitation at an outpatient clinic

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged between 18 and 80 years of age at enrolment
• Reporting intermittent or persistent low back pain for at least 12 weeks, and/or present at least 50% of the time in the past 6 months
• Ability to understand complex motor tasks

You may not qualify if:

• Known pregnancy
• Submitted to spinal surgery less than 3 months ago
• Symptoms and/or signs indicative of possible infectious disorder
• Known disorder with indication for spine surgery (i.e., tumor, cauda equina syndrome)
• Cancer diagnosis or undergoing treatment for cancer
• Cardiac, respiratory or other known disorder incompatible with at least 20 minutes of light to moderate physical activity
• Concomitant neurological disorder (e.g. Stroke, multiple sclerosis, Parkinson's disease)
• Dementia or psychiatric disorders precluding patient from complying with a home-based exercise program
• Illiteracy and/or serious visual or auditory impairment interfering with communication or compliance

Sponsors & Collaborators

• Sword Health, SA: lead
• Emory University: collaborator

Study Sites (1)

Emory Orthopaedic and Spine Center (Atlanta, Ga)

Atlanta, Georgia, 30324, United States

Location

Limitations and Caveats

Lack of (i) blinding of patients, physical therapists, and investigators due to the intervention's nature; (ii) objective outcome measures (eg, muscle strength, range of motion); (iii) an externally blinded outcome adjudicator. The COVID-19 pandemic may have positively influenced compliance. Higher dropout in the conventional group highlights the need for strategies like additional contacts. Greater granularity in pharmacological data (type, dosage, frequency) is necessary.

Results Point of Contact

• Title: Fernando Dias Correia
• Organization: Sword Health Inc

fcorreia@swordhealth.com

+1 (646) 379-6751

Study Officials

• Cui Di, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding of investigators and patients regarding allocation arm will not be possible, given the nature of the intervention. Analysis of study results will be performed by a statistician blinded to allocation groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 22, 2021
• Study Start: May 25, 2021
• Primary Completion: November 16, 2022
• Study Completion: December 5, 2022
• Last Updated: May 16, 2025
• Results First Posted: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon study publication, for at least five years.
• Access Criteria: Study protocol will be made available in clinicaltrials.gov and the excel file with the aggregate results will be made available upon study publication, for at least 5 years.

Locations

US (1)