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

NCT04401683 | Withdrawn DMC

• 1 other identifier: SH-RCT-LBP-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Oswestry Disability Index (ODI) score

  The ODI is a condition-specific self-reported measure, that aims to assess the level of disability in different physical activities in patients with low back pain. Scoring: 10 items, each with 6 possible answers (scored from 0 to 5 points) and a total score ranging from 0-100, being 100 the worst function/disability possible. The total score of ODI is calculated through te total sum of the section scores, divided by the total possible score and the result is then multiplied by 100, to achieve a percentage score.

  Baseline, 6 weeks and 12 weeks after initiation of rehabilitation program

Secondary Outcomes (3)

• Change in Fear-Avoidance Beliefs Questionnaire (FABQ)

  Baseline, 6 weeks and 12 weeks after initiation of rehabilitation program

• Change in Pain Catastrophizing Scale (PCS)

  Baseline, 6 weeks and 12 weeks after initiation of rehabilitation program

• Change in Numeric Rating Scale (NRS) score

  Baseline, 6 weeks and 12 weeks after initiation of rehabilitation program

Study Arms (2)

Digital Rehabilitation

EXPERIMENTAL

Standard medical treatment + Fully remote rehabilitation program with a digital therapist

Device: Home-based rehabilitation with a digital biofeedback system

Conventional Rehabilitation

ACTIVE COMPARATOR

Standard medical treatment + Home-based rehabilitation program

Other: Conventional home-based rehabilitation

Interventions

Home-based rehabilitation with a digital biofeedback system DEVICE

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.

Digital Rehabilitation

Conventional home-based rehabilitation OTHER

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.

Conventional Rehabilitation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 18 and 70 years
• Intermittent or persistent low back pain for at least 3 months and on at least half the days in the previous 6 months without peripheral symptoms
• Ability to understand motor complex commands

You may not qualify if:

• Pregnancy or breast-feeding
• Inability to stand upright
• Clear indication for surgery or other medical treatment (e.g. cancer, infection, cauda equina syndrome, significant lumbar disc herniation or rupture, nerve compression)
• Acute low back pain in the past 7 days or unilateral or bilateral radicular pain
• Neurologic condition (e.g. stroke, multiple sclerosis, Parkinson's disease)
• Concomitant treatment for LBP
• Cardiac, respiratory or other condition incompatible with at least 30 minutes of light to moderate physical activity
• Severe reduction of visual and/or auditory acuity, aphasia, dementia or psychiatric comorbidity significantly interfering with communication or compliance to a home-based exercise program
• Osteoarticular condition (e.g. fractures or severe osteoarthrosis) that prevents the patient from complying with a home-based exercise program
• Other medical complications that prevent the patient from complying with a home-based exercise program
• Illiteracy

Sponsors & Collaborators

• Sword Health, SA: lead
• Centro Hospitalar e Universitário do Porto: collaborator

Study Sites (1)

Centro Hospitalar e Universitário do Porto - Largo Prof Abel Salazar

Porto, 4099-001, Portugal

Location

Study Officials

• Sérgio Moreira, MD

  Centro Hospitalar e Universitário do Porto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 26, 2020
• Study Start: May 25, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: May 28, 2021

Record last verified: 2021-03

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

PT (1)