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

NCT05859425 | Completed

• 1 other identifier: 01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-specific Low Back Pain (NSLBP)

Outcome Measures

Primary Outcomes (1)

• 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

  Change from baseline Numeric Pain Rating Scale at 2 months

Secondary Outcomes (4)

• Roland-Morris Disability Questionnaire (RMDQ)

  Change from baseline Roland Morris Disability Questionannaire at 2 months

• Hospital Anxiety and Depression Scale (HADS)

  Change from baseline Hospital Anxiety and Depression Scale at 2 months

• Transversus Abdominus (TrA) Activation Level

  Change from the baseline Transversus abdominus activation level at 2 months

• Motor Control Tests (MCT)

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

Study Arms (2)

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.

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.

Other: Tactile feedback (control intervention)

Interventions

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

US-guided biofeedback intervention

Tactile feedback (control intervention) OTHER

Palpatory-guided (manual) feedback for TrA activation

Control (non-US guided) group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Patras: lead
• University of Crete: collaborator

Study Sites (1)

Laboratory of Clinical Rehabilitation and Research

Pátrai, Achaia, Greece

Location

Study Officials

• Evdokia Billis

  University of Patras

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Physiotherapy

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 16, 2023
• Study Start: January 15, 2022
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)