Evaluation of Stabilization Training With Biofeedback in Lumbosacral Spine Pain Syndrome

NCT07463729 | Not Yet Recruiting

• 1 other identifier: Biofeedback Stabilization
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to evaluate the effects of biofeedback-assisted stabilization training and conventional therapy on pain perception, balance, spinal mobility, functional performance, physical activity, stress level, and quality of life in patients with lumbosacral spine pain syndrome treated conservatively. The main research questions the study seeks to answer are as follows: Whether and to what extent the implemented therapeutic program improves balance, spinal mobility, functional performance, physical activity, quality of life, and reduces pain perception and stress levels in patients with lumbosacral spine pain syndrome? Are there differences in therapeutic outcomes depending on the treatment method applied? Are the therapeutic effects maintained three months after completion of the intervention? Researchers will compare two groups: a control group and an experimental group. In the control group, stabilization training will be performed without the use of biofeedback. Participants will undergo clinical and functional assessments (Visual Analogue Scale, Oswestry Disability Index, force platform measurements, etc.). Depending on the group to which participants are randomly assigned, participants will participate in manual therapy, stabilization training, and selected physical therapy modalities. Participants will be continuously supervised by a physician and physiotherapists throughout the 8-week intervention period. Three months after completion of the intervention, participants will undergo a follow-up assessment.

Conditions

Low Back Pain; Chronic Low Back Pain

Keywords

Chronic low back pain; RUSI; UltrasoundBiofeedback; StabilizationExercises; LumbarStabilization

Outcome Measures

Primary Outcomes (12)

• Balance

  Measurement Tool: Force platform Unit of Measure: Numerical and percentage values determined by the electronic device; includes center of pressure (COP) position, COP path length, COP displacement speed, sway range in sagittal and frontal planes, percentage load on right and left lower limbs during double-leg stance, and postural control with eyes open and eyes closed

  First examination - before the start of the rehabilitation program

• Balance

  Measurement Tool: Force platform Unit of Measure: Numerical and percentage values determined by the electronic device; includes center of pressure (COP) position, COP path length, COP displacement speed, sway range in sagittal and frontal planes, percentage load on right and left lower limbs during double-leg stance, and postural control with eyes open and eyes closed

  Second examination - at the end of the eight-week program

• Balance

  Measurement Tool: Force platform Unit of Measure: Numerical and percentage values determined by the electronic device; includes center of pressure (COP) position, COP path length, COP displacement speed, sway range in sagittal and frontal planes, percentage load on right and left lower limbs during double-leg stance, and postural control with eyes open and eyes closed

  Follow-up assessment at 3 months post-intervention.

• Pain intensity Visual Analog Scale

  The Visual Analog Scale (VAS) Unit of Measure: Pain intensity is measured on a scale from 0 to 10 using the Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity Measurement Tool: The Visual Analog Scale (VAS) will be used to allow patients to self-report perceived pain intensity.

  First examination - before the start of the rehabilitation program

• Pain intensity Visual Analog Scale

  The Visual Analog Scale (VAS) Unit of Measure: Pain intensity is measured on a scale from 0 to 10 using the Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity Measurement Tool: The Visual Analog Scale (VAS) will be used to allow patients to self-report perceived pain intensity.

  Second examination - at the end of the eight-week program

• Pain intensity Visual Analog Scale

  The Visual Analog Scale (VAS) Unit of Measure: Pain intensity is measured on a scale from 0 to 10 using the Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity Measurement Tool: The Visual Analog Scale (VAS) will be used to allow patients to self-report perceived pain intensity.

  Follow-up assessment at 3 months post-intervention.

• Pain Questionnaire

  McGill Pain Questionnaire - Short Form; Evaluation: The McGill Pain Questionnaire - Short Form is a concise tool (15 descriptors) for rapid, multidimensional assessment of pain, including sensory and affective components, as well as pain intensity. Unit of Measure: Patients rate each descriptor on a scale from 0 to 3 (0 = none, 3 = severe). Higher total scores indicate more intense and distressing pain. Measurement Tool: The Short-Form McGill Pain Questionnaire (SF-MPQ) will be used to allow patients to self-report both the intensity and qualitative characteristics of participants pain.

  First examination - before the start of the rehabilitation program

• Pain Questionnaire

  McGill Pain Questionnaire - Short Form; Evaluation: The McGill Pain Questionnaire - Short Form is a concise tool (15 descriptors) for rapid, multidimensional assessment of pain, including sensory and affective components, as well as pain intensity. Unit of Measure: Patients rate each descriptor on a scale from 0 to 3 (0 = none, 3 = severe). Higher total scores indicate more intense and distressing pain. Measurement Tool: The Short-Form McGill Pain Questionnaire (SF-MPQ) will be used to allow patients to self-report both the intensity and qualitative characteristics of participants pain.

  Second examination - at the end of the eight-week program

• Pain Questionnaire

  McGill Pain Questionnaire - Short Form; Evaluation: The McGill Pain Questionnaire - Short Form is a concise tool (15 descriptors) for rapid, multidimensional assessment of pain, including sensory and affective components, as well as pain intensity. Unit of Measure: Patients rate each descriptor on a scale from 0 to 3 (0 = none, 3 = severe). Higher total scores indicate more intense and distressing pain. Measurement Tool: The Short-Form McGill Pain Questionnaire (SF-MPQ) will be used to allow patients to self-report both the intensity and qualitative characteristics of participants pain.

  Follow-up assessment at 3 months post-intervention.

• Disability related to spinal pain

  Assessment of disability related to spinal pain using the Oswestry Disability Index (ODI). Evaluation: Functional disability associated with lumbosacral spine pain. Unit of Measure: The ODI score is expressed as a percentage, calculated from 10 sections (0-5 points each). The total score ranges from 0% to 100%, where higher scores indicate greater disability. Interpretation of scores is as follows: 0-20%: Minimal disability 21-40%: Moderate disability 41-60%: Severe disability 61-80%: Crippling disability 81-100%: Bed-bound or exaggerating symptoms Measurement Tool: The Oswestry Disability Index (ODI) questionnaire will be used to allow patients to self-report limitations in daily activities related to spinal pain.

  First examination - before the start of the rehabilitation program

• Disability related to spinal pain

  Assessment of disability related to spinal pain using the Oswestry Disability Index (ODI). Evaluation: Functional disability associated with lumbosacral spine pain. Unit of Measure: The ODI score is expressed as a percentage, calculated from 10 sections (0-5 points each). The total score ranges from 0% to 100%, where higher scores indicate greater disability. Interpretation of scores is as follows: 0-20%: Minimal disability 21-40%: Moderate disability 41-60%: Severe disability 61-80%: Crippling disability 81-100%: Bed-bound or exaggerating symptoms Measurement Tool: The Oswestry Disability Index (ODI) questionnaire will be used to allow patients to self-report limitations in daily activities related to spinal pain.

  Second examination - at the end of the eight-week program

• Disability related to spinal pain

  Assessment of disability related to spinal pain using the Oswestry Disability Index (ODI). Evaluation: Functional disability associated with lumbosacral spine pain. Unit of Measure: The ODI score is expressed as a percentage, calculated from 10 sections (0-5 points each). The total score ranges from 0% to 100%, where higher scores indicate greater disability. Interpretation of scores is as follows: 0-20%: Minimal disability 21-40%: Moderate disability 41-60%: Severe disability 61-80%: Crippling disability 81-100%: Bed-bound or exaggerating symptoms Measurement Tool: The Oswestry Disability Index (ODI) questionnaire will be used to allow patients to self-report limitations in daily activities related to spinal pain.

  Follow-up assessment at 3 months post-intervention.

Secondary Outcomes (15)

• Spinal Range of Motion

  First examination - before the start of the rehabilitation program

• Spinal Range of Motion

  Second examination - at the end of the eight-week program

• Spinal Range of Motion

  Follow-up assessment at 3 months post-intervention.

• Physical activity level

  First examination - before the start of the rehabilitation program

• Physical activity level

  Second examination - at the end of the eight-week program

Study Arms (2)

Biofeedback Group

EXPERIMENTAL

The investigators use in this group standard physiotherapy and ultrasonography as Biofeedback-Assisted Stabilization Training to activate deep muscle of spine.

Other: Standard Rehabilitation; Other: Biofeedback Ultrasonography

Control Group

OTHER

In this group the investigators use standard physiotherapy without ultrasonography as biofeedback.

Other: Standard Rehabilitation

Interventions

Standard Rehabilitation OTHER

Standard Rehabilitation; Participants in the experimental group will undergo an 8-week rehabilitation program (2 sessions per week) that includes: Manual therapy, Physical therapy modalities, including TENS (Transcutaneous Electrical Nerve Stimulation) and therapeutic ultrasound, applied according to current conservative treatment standards, Standard exercises including muscle stretching, neural mobilization, diaphragmatic breathing, and exercises targeting deep trunk muscles.

Biofeedback Group; Control Group

Biofeedback Ultrasonography OTHER

Biofeedback Ultrasonography: exercises targeting the deep muscles of the spine, performed using ultrasonography for motor learning. The biofeedback allows real-time visualization of deep muscle activation (e.g., transverse abdominal, Pelvic floor muscles), helping participants optimize contraction patterns and improve neuromuscular control of the lumbosacral spine.

Biofeedback Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed chronic lumbosacral spine pain syndrome (score \>4 on the Keele STarT Back Screening Tool)
• Lumbosacral pain intensity \>3 on the Visual Analog Scale (VAS) persisting for at least the past 3 months
• Age between 30 and 65 years
• No concurrent participation in another rehabilitation program
• Provision of written informed consent to participate in the study

You may not qualify if:

• Acute phase of lumbosacral spine pain syndrome
• Presence of neurological symptoms such as paresthesia, dysesthesia, impaired superficial sensation, impaired pain sensation, muscle strength below grade 3 on the Lovett scale in the lower limbs, sphincter dysfunction, or cauda equina syndrome
• Recent fractures of the spine or pelvis (less than 6 months since injury)
• Segmental instability confirmed by functional X-ray or magnetic resonance imaging (MRI)
• Spondylolisthesis greater than Grade I according to the Meyerding classification
• Coexisting neurological (e.g., Parkinson's disease, neuropathies), autoimmune (e.g., ankylosing spondylitis), orthopedic (lower limb disorders), or oncological diseases
• Pregnancy
• Active use of analgesic or anti-inflammatory pharmacotherapy (e.g., steroids, NSAIDs)
• Concurrent participation in other rehabilitation programs or failure to complete the 8-week therapy program
• Completion of any structured rehabilitation program within the past 3 months
• Lack of informed consent to participate in the study

Sponsors & Collaborators

• University of Rzeszow: lead

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Krystian Mleczko, MSc in Physiotherapy

  University of Rzeszow, Medical and Rehabilitation Center in Tarnów Reha Medica, Tarnow

  PRINCIPAL INVESTIGATOR

• Agnieszka Guzik, Professor

  University of Rzeszow

  STUDY CHAIR

• Agnieszka Wolan-Nieroda, PhD

  University of Rzeszow

  STUDY CHAIR

Central Study Contacts

Krystian Mleczko, MSc in Physiotherapy

CONTACT

+48 781839950; krystianmleczko99@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned to one of two parallel groups: an experimental group or a control group. In the control group, an 8-week program (twice weekly) will be implemented, including manual therapy, physical therapy modalities, and therapeutic exercises. In the experimental group, participants will receive the same interventions as described above, with the addition of exercises using biofeedback to facilitate activation of the deep stabilizing muscles of the lumbosacral spine. In both groups, participants will undergo assessments before the intervention, after 8 weeks (post-intervention), and 3 months following completion of the intervention (follow-up).

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 11, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share