Clinical trial NCT05859425: Ultrasound-guided Biofeedback for Transversus Abdominus Re-education in Non-specific Low Back Pain Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-specific Low Back Pain (NSLBP)
Lead sponsor: University of Patras
Sponsor class: OTHER
Collaborators: name: University of Crete
First posted: 2023-05-16
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* adults aged 18-60 years-old
* suffered from NSLBP lasting longer than 12 weeks, producing moderate or severe disability

Exclusion Criteria:

* people with previous spinal surgery
* people suffering from systemic diseases
* pregnant women

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Change from baseline Numeric Pain Rating Scale at 2 months
Secondary outcomes:
measure: Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: Change from baseline Roland Morris Disability Questionannaire at 2 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from baseline Hospital Anxiety and Depression Scale at 2 months
measure: Transversus Abdominus (TrA) Activation Level
timeFrame: Change from the baseline Transversus abdominus activation level at 2 months
measure: Motor Control Tests (MCT)
timeFrame: Change from the baseline motor control tests (how many performed CORRECTLY) at 2 months
Other outcomes:
Locations:
city: Patras
country: Greece
facility: Laboratory of Clinical Rehabilitation and Research
state: Achaia
Study officials:
affiliation: University of Patras
name: Evdokia Billis
role: PRINCIPAL_INVESTIGATOR
References: