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Completed

NCT Number: NCT05859425

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

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.

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Key information

Conditions

Non-specific Low Back Pain (NSLBP)

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory of Clinical Rehabilitation and Research

Pátrai, Achaia, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Real-time rehabilitative ultrasound imaging (RUSI)

Device

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

Tactile feedback (control intervention)

Other

Palpatory-guided (manual) feedback for TrA activation

Primary outcomes

  1. Numeric Pain Rating Scale (NPRS)

    Time frame: Change from baseline Numeric Pain Rating Scale at 2 months

    Pain intensity measure, in a 0-10 point scale, where 0 refers to NO PAIN and 10 to the WORST PAIN

Secondary outcomes

  1. Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: Change from baseline Roland Morris Disability Questionannaire at 2 months

    Disability measure, in a 0-24 point scale, where 0 refers to no disability and 10 to severe disability

  2. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Change from baseline Hospital Anxiety and Depression Scale at 2 months

    Anxiety and Depression scale, measuring Anxiety and Depresion. Each subscale is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression.

  3. Transversus Abdominus (TrA) Activation Level

    Time frame: Change from the baseline Transversus abdominus activation level at 2 months

    Muscular assessment for evaluating TrA activation level using the stabilizer pressure biofeedback unit (Chattanooga Group model, US) was developed and tested for its reliability for the purposes of this study. The activation levels for allowing exercise progressions to take place were determined (categorically) as follows: Level 1: Single contraction of the TrA, lasting 10sec Level 2: Three TrA abdominal contractions, lasting 10sec Level 3: Ten abdominal TrA contractions, lasting 10sec Level 4: Holding the TrA contraction while performing 5 repetitions of side bend-ing (and return) of each leg (bend knee fallout and return) Level 5: Holding the TrA contraction while performing 5 bend leg raises on each leg Level 6: Holding the TrA contraction while performing 5 repetitions of bending and extending each leg (leg slides).

  4. Motor Control Tests (MCT)

    Time frame: Change from the baseline motor control tests (how many performed CORRECTLY) at 2 months

    7 lumbopelvic clinical tests for assessming control of movement (marked as CORRECT or INCORRECT -nominal type data) Seven reliable motor control tests previously utilized with chronic NSLBP populations. These were: i) waiters bow, ii) pelvic tilt, iii) hook lying position, iv) quadruped position (flexion-control), v) quadruped position (exten-sion-control), vi) prone lying active knee flexion and vii) sitting knee extension. An in-ter-tester reliability procedure for these tests was conducted prior to data collection. Physiotherapists (testers) visually evaluated the movement quality of these tests, marked as correct or incorrect, as indicated in relevant literature.

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Collaborators

  • University of Crete

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 16, 2023
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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