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

Primary Purpose

Non-specific Low Back Pain (NSLBP)

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Real-time rehabilitative ultrasound imaging (RUSI)
Tactile feedback (control intervention)
Sponsored by
University of Patras
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-specific Low Back Pain (NSLBP)

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Laboratory of Clinical Rehabilitation and Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

US-guided biofeedback intervention

Control (non-US guided) group

Arm Description

This group received visual feedback using real-time ultrasound (US) for transversus abdominus (TrA) activation, while performing the exercise programme. US-guided 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 the user (health professional-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.

The control group received the traditional tactile feedback from the therapist while performing the motor control exercises for TrA activation. Traditionally, assessment of TrA contraction involves palpation of the muscles. The ability to assess TrA through muscle palpation is largely dependent on examiner's skill, as TrA cannot be directly palpated (feedback sensation being limited from internal oblique muscle). To control the activation of the abdominals the therapist placed his hands on the inside of the anterior superior iliac crests (tactile feedback) and instructed the examinee to pull the abdominal wall inward without moving the spine or pelvis (verbal feedback). The same exercise protocol to the experimental group was performed in this (control) group.

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale (NPRS)
Pain intensity measure, in a 0-10 point scale, where 0 refers to NO PAIN and 10 to the WORST PAIN

Secondary Outcome Measures

Roland-Morris Disability Questionnaire (RMDQ)
Disability measure, in a 0-24 point scale, where 0 refers to no disability and 10 to severe disability
Hospital Anxiety and Depression Scale (HADS)
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.
Transversus Abdominus (TrA) Activation Level
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).
Motor Control Tests (MCT)
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.

Full Information

First Posted
April 26, 2023
Last Updated
May 16, 2023
Sponsor
University of Patras
Collaborators
University of Crete
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1. Study Identification

Unique Protocol Identification Number
NCT05859425
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
January 15, 2023 (Actual)
Study Completion Date
January 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Patras
Collaborators
University of Crete

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-specific Low Back Pain (NSLBP)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
US-guided biofeedback intervention
Arm Type
Experimental
Arm Description
This group received visual feedback using real-time ultrasound (US) for transversus abdominus (TrA) activation, while performing the exercise programme. US-guided 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 the user (health professional-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.
Arm Title
Control (non-US guided) group
Arm Type
Active Comparator
Arm Description
The control group received the traditional tactile feedback from the therapist while performing the motor control exercises for TrA activation. Traditionally, assessment of TrA contraction involves palpation of the muscles. The ability to assess TrA through muscle palpation is largely dependent on examiner's skill, as TrA cannot be directly palpated (feedback sensation being limited from internal oblique muscle). To control the activation of the abdominals the therapist placed his hands on the inside of the anterior superior iliac crests (tactile feedback) and instructed the examinee to pull the abdominal wall inward without moving the spine or pelvis (verbal feedback). The same exercise protocol to the experimental group was performed in this (control) group.
Intervention Type
Device
Intervention Name(s)
Real-time rehabilitative ultrasound imaging (RUSI)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Tactile feedback (control intervention)
Intervention Description
Palpatory-guided (manual) feedback for TrA activation
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
Pain intensity measure, in a 0-10 point scale, where 0 refers to NO PAIN and 10 to the WORST PAIN
Time Frame
Change from baseline Numeric Pain Rating Scale at 2 months
Secondary Outcome Measure Information:
Title
Roland-Morris Disability Questionnaire (RMDQ)
Description
Disability measure, in a 0-24 point scale, where 0 refers to no disability and 10 to severe disability
Time Frame
Change from baseline Roland Morris Disability Questionannaire at 2 months
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
Change from baseline Hospital Anxiety and Depression Scale at 2 months
Title
Transversus Abdominus (TrA) Activation Level
Description
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).
Time Frame
Change from the baseline Transversus abdominus activation level at 2 months
Title
Motor Control Tests (MCT)
Description
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.
Time Frame
Change from the baseline motor control tests (how many performed CORRECTLY) at 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evdokia Billis
Organizational Affiliation
University of Patras
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Clinical Rehabilitation and Research
City
Patras
State/Province
Achaia
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
As this is a pilot study, we think we would be happy to proceed further and then make data publicly available.

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

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