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Home-based Exercise Rehabilitation With a Novel Digital Biofeedback System for Chronic Low Back Pain

NCT04401683 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-05-28

No results posted yet for this study

Summary

The present study is a a single-center, prospective, non-blind, parallel-group, randomized controlled trial, designed to evaluate the clinical impact of a home-based program using a new digital solution on the treatment of non-specific chronic low back pain (CLBP) in adults versus standard of care.

The hypothesis is that all the clinical outcomes measured will significantly improve after the program, and patients using this novel system will attain better outcomes than the ones in the standard of care group.

This evidence-based digital program developed by SWORD Health is built on three main pillars - therapeutic exercise, education and cognitive-behavioural therapy, and is specifically tailored to address CLBP. The program will be delivered directly at patient's home, using a biofeedback system and continuous personalised remote clinical monitoring.

Conditions

  • Non-specific Chronic Low Back Pain

Interventions

DEVICE

Home-based rehabilitation with a digital biofeedback system

Participants in the experimental group will perform a 12-week digital exercise program, to be performed independently at home using the SWORD Phoenix® medical device, under remote monitoring from a physical therapist. Additionally, both groups will have access to standard medical treatments and to an educational program, specifically developed to target chronic low back pain, consisting of a booklet containing pathology-related information, causes, treatment recommendations, as well as suggestions of cognitive behavioural therapy exercises.

OTHER

Conventional home-based rehabilitation

Participants in the control group will benefit from a 12-week home-based rehabilitation program, consisting of 12 face-to-face sessions (1 per week) with a physical therapist, complemented by additional non-supervised sessions. Both supervised and unsupervised sessions will follow the same set of exercises defined for the experimental group. Additionally, both groups will have access to standard medical treatments and to an educational program, specifically developed to target chronic low back pain, consisting of a booklet containing pathology-related information, causes, treatment recommendations, as well as suggestions of cognitive behavioural therapy exercises.

Sponsors & Collaborators

  • Centro Hospitalar e Universitário do Porto

    collaborator UNKNOWN

  • Sword Health, SA

    lead INDUSTRY

Principal Investigators

  • Sérgio Moreira, MD · Centro Hospitalar e Universitário do Porto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-05-25
Primary Completion
2022-07-01
Completion
2022-07-01

Countries

  • Portugal

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 NCT04401683 on ClinicalTrials.gov