An investigator initiated validation study comparing ViMove with standardized outcome measures of function and disability.

Not Applicable

Completed

• Conditions: ow back pain (with or without leg pain) for > 3 months; Low back pain (with or without leg pain) for > 3 months; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12616001722482
• Lead Sponsor: Precision Brain, Spine and Pain Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Adults aged over 18 and < 65
2.Low Back pain for > 3 months
3.Pain score (as measured by a Numeric Rating Scale [NRS]) at baseline = or > 3
4.Able to provide informed consent
5. Does not meet any of the exclusion criteria

Exclusion Criteria

1.Acute back pain (< 3 months)
2.Performance of assessment protocol is contraindicated for the participant
3.Illness or injury other than lower back pain that impacts upon function or causes disability or an inability to move independently.
4.Is pregnant or planning to become pregnant during the course of the study
5.Participants with a severe hearing impairment or inability to follow verbal instructions.
6.Significant medical or psychological abnormalities/conditions, a history of substance abuse or recent history of a medical-surgical intervention that in the opinion of the investigator would interfere either with the ability to complete the study or the assessments.
7.Known allergy skin reaction to tapes and plasters.
8.Participant who is currently enrolled in an investigational drug or device study
9.Inability to comply with study requirements or complete questionnaires in English independently.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Movement data from ViMove sensors:<br>- maximum range of movement during lumbar flexion, extension, and lateral flexion[The timepoints for this will occur at the end of each of the two assessment days.<br>These two days were referred to as Initial Assessment and follow-up, and occur 8 weeks apart.];Lumbar maximum flexion range of movement as a proportion of trunk flexion movement (%Lumbar/Trunk).<br>This is automatically assessed using Vimove sensors and accompanying propriertary software. Output will be viewable on the computer/tablet that is used during the assessment.[The timepoints for this will occur at the end of each of the two assessment days.<br>These two days were referred to as Initial Assessment and follow-up, and occur 8 weeks apart.];Activity limitation measured with the Oswestry Disability Index[The timepoints for this will occur at the end of each of the two assessment days.<br>These two days were referred to as Initial Assessment and follow-up, and occur 8 weeks apart.]