NCT05859425

Ultrasound-guided Biofeedback for Transversus Abdominus Re-education in Non-specific Low Back Pain Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of Patras · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

As rehabilitative ultrasound imaging (RUSI) for monitoring and re-educating deep trunk muscles is becoming more and more popular in current musculoskeletal rehabilitation and research, the purpose of this pilot study was to explore the effects of applying ultrasound-guided imaging as a means of feedback for the activation/contraction of the deep transervsus abdominis muscle of the trunk during an exercise programme in people with non-specific low back pain (NSLBP). The outcome mesures being explored were pain intensity (primary outcome) through Numeric Pain Rating Scale (NPRS), functional, muscular and psychosocial parameters.

Detailed description

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). Thus, this pilot study aimed 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 would receive physiotherapy twice per week for 7 weeks. Outcome measures, tested 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). Analysis of variance utilizing a two-way mixed 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 between- and within-group differences before and after treatment. Additionally, independent samples' t-test and paired samples' t-test are used for differences between and within groups, respectively, as well as χ2 tests for differences on the motor control tests and the TrA activation level procedure across the groups.

Conditions

• Non-specific Low Back Pain (NSLBP)

Interventions

Type	Name	Description
DEVICE	Real-time rehabilitative ultrasound imaging (RUSI)	Τhe ultrasound equipment used was B-K Μedical Mini Focus 1402 equipped with high frequency linear probe (8670, 5-12MHz) using standard musculoskeletal settings and the software: V 1.01.01.137. Ultrasound gel (AQUASONIC® 100, Parker Inc., Orange, NJ) was used as coupling agent. TrA imaging was initially performed with participants in crook lying, with the US head positioned along the lateral abdominal wall with reference points at the lower point of the rib cage (last rib) and the anterior superior iliac spine, on the right side of the person, midway between these two points. The US head was moved until tester (investigator) had the best possible visualization of the lateral abdominal muscles (external oblique, internal oblique and TrA). During the execution of the exercises, the participants could watch the ultrasound screen along with the therapist's guidance, thus receiving information (US-visual feedback) of their TrA activation
OTHER	Tactile feedback (control intervention)	Palpatory-guided (manual) feedback for TrA activation

Timeline

• Start date: 2022-01-15
• Primary completion: 2023-01-15
• Completion: 2023-01-15
• First posted: 2023-05-16
• Last updated: 2023-05-18

Locations

1 site across 1 country: Greece