Investigation of Real-time Diagnostic Ultrasound as a Means of Biofeedback Training in Transversus Abdominus Re-education of Patients With Non-specific Low Back Pain: Prospective Randomized Controlled Pilot Study
Phase: NA
Conditions: Non-specific Low Back Pain (NSLBP)
Sponsor: University of Patras

Cover page  
 
Oﬃcial Title of the study: 
InvesƟgaƟon of Real-Ɵme DiagnosƟc Ultrasound as a Means of Biofeedback 
Training in Transversus Abdominus Re-educaƟon of PaƟents With Non-speciﬁc Low 
Back Pain: ProspecƟve Randomized Controlled Pilot Study   
 
Date of the document: 4/5/2023 
 
Document Type: Study Protocol with SAP 
Background: It is believed that ultrasound-guided imaging of activation/contraction of the 
deep abdominal muscles (such as transervsus abdominis) is useful for assisting deep muscle 
re-education, which is often dysfunctional in non-specific low back pain (NSLBP).  
Objective: This pilot study’s objective was to evaluate the use of real-time ultrasound (US) as 
a feedback device for transverse abdominis (TrA) activation/contraction during an exercise 
program in chronic NSLBP patients.  
Methods: Chronic NSLBP patients are recruited and randomly assigned to an US-guided or 
control group. The same motor control-based exercise program is applied to both groups. All 
patients receive physiotherapy twice per week for 7 weeks. Outcome measures, test at baseline 
and post-intervention, include Numeric Pain Rating Scale (NPRS), TrA activation level 
(measured through a pressure biofeedback unit-based developed protocol), seven established 
motor control tests, Roland-Morris Disability Questionnaire (RMDQ) and Hospital Anxiety 
and Depression Scale (HADS).  
Statistical Analysis Plan: Analysis of variance utilizing a two-way mixed analysis of variance 
(ANOVA) model for dependent measures of two factors (treatment group and time point of 
measurement) of which only one is repeated (time point of measurement) is performed to 
determine whether there were between- and within-group differences before and after 
treatment. Independent samples’ t-test and paired samples’ t-test are also used for differences 
between and within groups, respectively. An χ2 test was also conducted for differences on the 
motor control tests and the TrA activation level procedure across the groups.