Non-specific Low Back Pain (NSLBP)NCT05859425
Ultrasound-guided Biofeedback for Transversus Abdominus Re-education in Non-specific Low Back Pain Patients
A study testing Real-time rehabilitative ultrasound imaging (RUSI) in people with Non-specific Low Back Pain (NSLBP), run by University of Patras at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Non-specific Low Back Pain (NSLBP)
- What is being tested?
- Real-time rehabilitative ultrasound imaging (RUSI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteGreece
- Study dates
- 15 Jan 2022to 15 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adults aged 18-60 years-old
- suffered from NSLBP lasting longer than 12 weeks, producing moderate or severe disability
Who cannot join
- people with previous spinal surgery
- people suffering from systemic diseases
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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)
- Being tested
- Real-time rehabilitative ultrasound imaging (RUSI), Tactile feedback (control intervention)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| US-guided biofeedback intervention | Experimental | 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. Receives: Device: Real-time rehabilitative ultrasound imaging (RUSI) |
| Control (non-US guided) group | Active comparator | 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. Receives: Other: Tactile feedback (control intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline Numeric Pain Rating Scale at 2 months
Secondary outcomes (4)
Roland-Morris Disability Questionnaire (RMDQ)
Disability measure, in a 0-24 point scale, where 0 refers to no disability and 10 to severe disability
Measured: Change from baseline Roland Morris Disability Questionannaire at 2 months
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.
Measured: Change from baseline Hospital Anxiety and Depression Scale at 2 months
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).
Measured: Change from the baseline Transversus abdominus activation level at 2 months
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.
Measured: Change from the baseline motor control tests (how many performed CORRECTLY) at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start15 Jan 2022
- Primary completion15 Jan 2023
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-specific Low Back Pain (NSLBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Collaborators
- University of Crete
- Responsible party
- Principal investigator, Evdokia Billis, University of Patras
- Investigators
- Evdokia Billis, Principal investigator, University of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859425
- Sponsor's protocol ID
- 01
- Status last verified
- May 2023
- First submitted
- 26 Apr 2023
- Last updated
- 18 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As this is a pilot study, we think we would be happy to proceed further and then make data publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05859425
- Acronym / sponsor ID
- 01
- Conditions
- Non-specific Low Back Pain (NSLBP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Collaborators
- University of Crete
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US-guided biofeedback intervention | Experimental | Device: Real-time rehabilitative ultrasound imaging (RUSI)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. |
| Control (non-US guided) group | Active comparator | Other: Tactile feedback (control intervention)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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- adults aged 18-60 years-old
- suffered from NSLBP lasting longer than 12 weeks, producing moderate or severe disability
Key exclusion criteria (3 listed)
- people with previous spinal surgery
- people suffering from systemic diseases
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | US-guided biofeedback intervention |
| Tactile feedback (control intervention)Palpatory-guided (manual) feedback for TrA activation | Other | Control (non-US guided) group |
Primary outcome
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
4 secondary outcomes
Roland-Morris Disability Questionnaire (RMDQ)
Time frame: Change from baseline Roland Morris Disability Questionannaire at 2 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: Change from baseline Hospital Anxiety and Depression Scale at 2 months
Transversus Abdominus (TrA) Activation Level
Time frame: Change from the baseline Transversus abdominus activation level at 2 months
Motor Control Tests (MCT)
Time frame: Change from the baseline motor control tests (how many performed CORRECTLY) at 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evdokia Billis principal investigator
University of Patras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time rehabilitative ultrasound imaging (RUSI) in people with Non-specific Low Back Pain (NSLBP), run by University of Patras at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: Change from baseline Numeric Pain Rating Scale at 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.