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NCT Number: NCT07463729

Evaluation of Stabilization Training With Biofeedback in Lumbosacral Spine Pain Syndrome

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.

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Key information

Conditions

Low Back Pain Back Pain Chronic Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical and Rehabilitation Center in Tarnów Reha Medica

Tarnów, Małopolska, 33-100, Poland

Location status: Recruiting

Location contact

Agnieszka Guzik, professor

CONTACT

Krystian Mleczko, Msc

CONTACT

[email protected]

781839950 ext. +48

About this study

The study is interventional, prospective, randomized, and controlled in design. Its objective is to determine whether stabilization training using ultrasonography as a biofeedback tool leads to improved therapeutic outcomes compared with standard physiotherapy. The intervention is intended for patients with chronic lumbosacral spine pain lasting at least three months. Eligibility for participation will be based on clearly defined inclusion criteria. This study will be conducted at REHA MEDICA Rehabilitation and Medical Center in Tarnów, Poland. The investigators plan to enroll approximately 110 patients, with 55 assigned to the control group and 55 to the experimental group.

The therapeutic program in both groups will include manual therapy, selected physical therapy modalities, and therapeutic exercises. Participants will be randomly assigned to either a control group or an experimental group. In the experimental group, biofeedback in the form of ultrasonography will be used during stabilization exercises, whereas in the control group, exercises will be performed without biofeedback.

The following parameters will be analyzed: pain intensity, the degree of disability associated with spinal pain, spinal range of motion, balance parameters assessed using a force platform, level of physical activity, stress severity, and self-reported quality of life.

The following tests and questionnaires will be used in the study:

The force platform will be used to assess balance, including center of pressure (COP) position, COP path length, COP displacement speed, sway range in the sagittal and frontal planes, percentage load on the right and left lower limbs during double-leg stance, and postural control with eyes open and eyes closed.

Inclinometer - for measuring the lumbar lordosis angle and the range of motion of the lumbosacral spine.

STarT Back Screening Tool - a questionnaire assessing the risk of developing chronic low back pain.

Oswestry Disability Index (ODI) - an index measuring disability related to lumbosacral spine pain.

McGill Pain Questionnaire - Short Form - evaluating pain quality and intensity. Visual Analog Scale (VAS) - for assessing pain intensity. Physical Activity Questionnaire - assessing the level of physical activity over the past seven days.

Perceived Stress Scale - a subjective measure of stress experienced over the past month.

WHOQOL-BREF - a quality of life questionnaire developed by the World Health Organization (World Health Organization Quality of Life - BREF).

Before entering the program, participants will be examined by a specialist in rehabilitation medicine. Subsequently, the principal investigator (physiotherapist) will conduct a baseline assessment including all analyzed parameters. After completing the qualification process, participants will begin an 8-week physiotherapy program conducted twice weekly. Immediately after completion of the intervention, a post-treatment assessment identical to the baseline evaluation will be performed. A follow-up assessment will then be conducted three months after completion of the therapy.

The study will be conducted under the supervision of qualified medical personnel and in accordance with all applicable safety standards. The results will determine whether the use of ultrasonography-based biofeedback improves clinical and functional outcomes and whether any therapeutic benefits are maintained over time. The findings may contribute to the optimization of rehabilitation programs for patients with chronic lumbosacral spine pain.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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 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.

Primary outcomes

  1. Balance

    Time frame: First examination - before the start of the rehabilitation program

    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

  2. Balance

    Time frame: Second examination - at the end of the eight-week program

    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

  3. Balance

    Time frame: Follow-up assessment at 3 months post-intervention.

    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

  4. Pain intensity Visual Analog Scale

    Time frame: First examination - before the start of the rehabilitation program

    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.

  5. Pain intensity Visual Analog Scale

    Time frame: Second examination - at the end of the eight-week program

    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.

  6. Pain intensity Visual Analog Scale

    Time frame: Follow-up assessment at 3 months post-intervention.

    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.

  7. Pain Questionnaire

    Time frame: First examination - before the start of the rehabilitation program

    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.

  8. Pain Questionnaire

    Time frame: Second examination - at the end of the eight-week program

    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.

  9. Pain Questionnaire

    Time frame: Follow-up assessment at 3 months post-intervention.

    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.

  10. Disability related to spinal pain

    Time frame: First examination - before the start of the rehabilitation program

    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.

  11. Disability related to spinal pain

    Time frame: Second examination - at the end of the eight-week program

    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.

  12. Disability related to spinal pain

    Time frame: Follow-up assessment at 3 months post-intervention.

    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.

Secondary outcomes

  1. Spinal Range of Motion

    Time frame: First examination - before the start of the rehabilitation program

    Spinal range of motion Evaluation: Mobility of the lumbar and lumbosacral spine. Unit of Measure: Degrees (°) of motion measured with an inclinometer; includes lumbar flexion, extension, lateral bending, and rotation. Higher values indicate greater spinal mobility.

    Measurement Tool: Inclinometer will be used to quantify exact angles of spinal movements.

  2. Spinal Range of Motion

    Time frame: Second examination - at the end of the eight-week program

    Spinal range of motion Evaluation: Mobility of the lumbar and lumbosacral spine. Unit of Measure: Degrees (°) of motion measured with an inclinometer; includes lumbar flexion, extension, lateral bending, and rotation. Higher values indicate greater spinal mobility.

    Measurement Tool: Inclinometer will be used to quantify exact angles of spinal movements.

  3. Spinal Range of Motion

    Time frame: Follow-up assessment at 3 months post-intervention.

    Spinal range of motion Evaluation: Mobility of the lumbar and lumbosacral spine. Unit of Measure: Degrees (°) of motion measured with an inclinometer; includes lumbar flexion, extension, lateral bending, and rotation. Higher values indicate greater spinal mobility.

    Measurement Tool: Inclinometer will be used to quantify exact angles of spinal movements.

  4. Physical activity level

    Time frame: First examination - before the start of the rehabilitation program

    Evaluation: Level of physical activity over the past seven days.

    Unit of Measure: Physical activity is expressed in MET-minutes/week based on the IPAQ - International Physical Activity Questionnaire (Short Form, SF). The questionnaire contains 7 questions regarding time spent on vigorous activity, moderate activity, walking, and sitting over the past 7 days. Interpretation of MET scores:

    <600 MET-min/week: Low physical activity 600-3000 MET-min/week: Moderate physical activity 3000 MET-min/week: High physical activity Measurement Tool: IPAQ - International Physical Activity Questionnaire (Short Form, SF) self-reported by participants to assess frequency, duration, and intensity of physical activity.

  5. Physical activity level

    Time frame: Second examination - at the end of the eight-week program

    Evaluation: Level of physical activity over the past seven days.

    Unit of Measure: Physical activity is expressed in MET-minutes/week based on the IPAQ - International Physical Activity Questionnaire (Short Form, SF). The questionnaire contains 7 questions regarding time spent on vigorous activity, moderate activity, walking, and sitting over the past 7 days. Interpretation of MET scores:

    <600 MET-min/week: Low physical activity 600-3000 MET-min/week: Moderate physical activity 3000 MET-min/week: High physical activity Measurement Tool: IPAQ - International Physical Activity Questionnaire (Short Form, SF) self-reported by participants to assess frequency, duration, and intensity of physical activity.

  6. Physical activity level

    Time frame: Follow-up assessment at 3 months post-intervention.

    Evaluation: Level of physical activity over the past seven days.

    Unit of Measure: Physical activity is expressed in MET-minutes/week based on the IPAQ - International Physical Activity Questionnaire (Short Form, SF). The questionnaire contains 7 questions regarding time spent on vigorous activity, moderate activity, walking, and sitting over the past 7 days. Interpretation of MET scores:

    <600 MET-min/week: Low physical activity 600-3000 MET-min/week: Moderate physical activity 3000 MET-min/week: High physical activity Measurement Tool: IPAQ - International Physical Activity Questionnaire (Short Form, SF) self-reported by participants to assess frequency, duration, and intensity of physical activity.

  7. Stress level

    Time frame: First examination - before the start of the rehabilitation program

    Evaluation: Perceived stress experienced over the past month. Unit of Measure: Numerical score from the Perceived Stress Scale (PSS-10). The questionnaire contains 10 questions, each scored from 0 to 4 points, giving a maximum total score of 40 points. Higher scores indicate higher levels of perceived stress.

    Measurement Tool: Perceived Stress Scale (PSS-10) self-reported by participants to assess subjective stress over the past month.

  8. Stress level

    Time frame: Second examination - at the end of the eight-week program

    Evaluation: Perceived stress experienced over the past month. Unit of Measure: Numerical score from the Perceived Stress Scale (PSS-10). The questionnaire contains 10 questions, each scored from 0 to 4 points, giving a maximum total score of 40 points. Higher scores indicate higher levels of perceived stress.

    Measurement Tool: Perceived Stress Scale (PSS-10) self-reported by participants to assess subjective stress over the past month.

  9. Stress level

    Time frame: Follow-up assessment at 3 months post-intervention.

    Evaluation: Perceived stress experienced over the past month. Unit of Measure: Numerical score from the Perceived Stress Scale (PSS-10). The questionnaire contains 10 questions, each scored from 0 to 4 points, giving a maximum total score of 40 points. Higher scores indicate higher levels of perceived stress.

    Measurement Tool: Perceived Stress Scale (PSS-10) self-reported by participants to assess subjective stress over the past month.

  10. Quality of life questionnaire

    Time frame: First examination - before the start of the rehabilitation program

    Evaluation: Concise questionnaire used for subjective assessment of quality of life in both healthy and patient populations. It evaluates four main domains: physical, psychological, social relationships, and environment.

    Unit of Measure: Standardized numerical scores (0-100 points) for each domain, where higher scores indicate better quality of life.

    Measurement Tool: WHOQOL-BREF self-reported by participants to assess perceived quality of life across the four domains.

  11. Quality of life questionnaire

    Time frame: Second examination - at the end of the eight-week program

    Evaluation: Concise questionnaire used for subjective assessment of quality of life in both healthy and patient populations. It evaluates four main domains: physical, psychological, social relationships, and environment.

    Unit of Measure: Standardized numerical scores (0-100 points) for each domain, where higher scores indicate better quality of life.

    Measurement Tool: WHOQOL-BREF self-reported by participants to assess perceived quality of life across the four domains.

  12. Quality of life questionnaire

    Time frame: Follow-up assessment at 3 months post-intervention.

    Evaluation: Concise questionnaire used for subjective assessment of quality of life in both healthy and patient populations. It evaluates four main domains: physical, psychological, social relationships, and environment.

    Unit of Measure: Standardized numerical scores (0-100 points) for each domain, where higher scores indicate better quality of life.

    Measurement Tool: WHOQOL-BREF self-reported by participants to assess perceived quality of life across the four domains.

  13. Risk of developing chronic low back pain

    Time frame: First examination - before the start of the rehabilitation program

    Evaluation: Likelihood of persistent low back pain becoming chronic. Unit of Measure: Categorical score using the STarT Back Screening Tool. The questionnaire consists of 9 questions referring to the past two weeks, with each question answered as agree or disagree. Participants are classified as low, medium, or high risk based on total responses.

    Measurement Tool: STarT Back Screening Tool self-reported by participants to assess risk of developing chronic low back pain.

  14. Risk of developing chronic low back pain

    Time frame: Second examination - at the end of the eight-week program

    Evaluation: Likelihood of persistent low back pain becoming chronic. Unit of Measure: Categorical score using the STarT Back Screening Tool. The questionnaire consists of 9 questions referring to the past two weeks, with each question answered as agree or disagree. Participants are classified as low, medium, or high risk based on total responses.

    Measurement Tool: STarT Back Screening Tool self-reported by participants to assess risk of developing chronic low back pain.

  15. Risk of developing chronic low back pain

    Time frame: Follow-up assessment at 3 months post-intervention.

    Evaluation: Likelihood of persistent low back pain becoming chronic. Unit of Measure: Categorical score using the STarT Back Screening Tool. The questionnaire consists of 9 questions referring to the past two weeks, with each question answered as agree or disagree. Participants are classified as low, medium, or high risk based on total responses.

    Measurement Tool: STarT Back Screening Tool self-reported by participants to assess risk of developing chronic low back pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Krystian Mleczko, MSc in Physiotherapy

CONTACT

[email protected]

+48 781839950

Sponsors and collaborators

Lead sponsor

University of Rzeszow

Other

Registry information

Official study title

Evaluation of the Effectiveness of Stabilization Training With Biofeedback in Patients With Lumbosacral Spine Pain Syndrome

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 11, 2026
Registry last updated
Apr 7, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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