Low Back PainNCT07463729
Evaluation of Stabilization Training With Biofeedback in Lumbosacral Spine Pain Syndrome
A study testing Standard Rehabilitation and Biofeedback Ultrasonography in people with Low Back Pain and Chronic Low Back Pain, run by University of Rzeszow at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Low Back Pain, Chronic Low Back Pain
- What is being tested?
- Standard Rehabilitation and Biofeedback Ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePoland
- Study dates
- 1 Apr 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Medical and Rehabilitation Center in Tarnów Reha Medica
Tarnów, Małopolska, 33-100
Krystian Mleczko, Msc, 781839950 ext. +48, krystianmleczko99@gmail.com
Agnieszka Guzik, professor
About this study
Official title: Evaluation of the Effectiveness of Stabilization Training With Biofeedback in Patients With 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.
Read the detailed description
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.
- Conditions
- Low Back Pain, Chronic Low Back Pain
- Being tested
- Standard Rehabilitation, Biofeedback Ultrasonography
- Keywords
- Chronic low back pain, RUSI, UltrasoundBiofeedback, StabilizationExercises, LumbarStabilization
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard RehabilitationOther
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 UltrasonographyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback Group | Experimental | The investigators use in this group standard physiotherapy and ultrasonography as Biofeedback-Assisted Stabilization Training to activate deep muscle of spine. Receives: Other: Standard Rehabilitation; Other: Biofeedback Ultrasonography |
| Control Group | Other | In this group the investigators use standard physiotherapy without ultrasonography as biofeedback. Receives: Other: Standard Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Follow-up assessment at 3 months post-intervention.
Secondary outcomes (15)
Spinal Range of Motion
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.
Measured: First examination - before the start of the rehabilitation program
Spinal Range of Motion
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.
Measured: Second examination - at the end of the eight-week program
Spinal Range of Motion
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.
Measured: Follow-up assessment at 3 months post-intervention.
Physical activity level
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.
Measured: First examination - before the start of the rehabilitation program
Physical activity level
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.
Measured: Second examination - at the end of the eight-week program
Physical activity level
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.
Measured: Follow-up assessment at 3 months post-intervention.
Stress level
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.
Measured: First examination - before the start of the rehabilitation program
Stress level
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.
Measured: Second examination - at the end of the eight-week program
Stress level
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.
Measured: Follow-up assessment at 3 months post-intervention.
Quality of life questionnaire
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.
Measured: First examination - before the start of the rehabilitation program
Quality of life questionnaire
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.
Measured: Second examination - at the end of the eight-week program
Quality of life questionnaire
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.
Measured: Follow-up assessment at 3 months post-intervention.
Risk of developing chronic low back pain
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.
Measured: First examination - before the start of the rehabilitation program
Risk of developing chronic low back pain
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.
Measured: Second examination - at the end of the eight-week program
Risk of developing chronic low back pain
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.
Measured: Follow-up assessment at 3 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start1 Apr 2026
- Primary completion31 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Model description
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rzeszow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krystian Mleczko, University of Rzeszow
- Investigators
- Krystian Mleczko, MSc in Physiotherapy, Principal investigator, University of Rzeszow, Medical and Rehabilitation Center in Tarnów Reha Medica, TarnowAgnieszka Guzik, Professor, Study chair, University of RzeszowAgnieszka Wolan-Nieroda, PhD, Study chair, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463729
- Sponsor's protocol ID
- Biofeedback Stabilization
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Stabilization Training With Biofeedback in Patients With Lumbosacral Spine Pain Syndrome
- ClinicalTrials.gov ID
- NCT07463729
- Acronym / sponsor ID
- Biofeedback Stabilization
- Conditions
- Low Back Pain, Chronic Low Back Pain
- Keywords
- Chronic low back pain, RUSI, UltrasoundBiofeedback, StabilizationExercises, LumbarStabilization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of RzeszowUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 11 Mar 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Biofeedback Group | Experimental | Other: Standard Rehabilitation, Other: Biofeedback UltrasonographyThe investigators use in this group standard physiotherapy and ultrasonography as Biofeedback-Assisted Stabilization Training to activate deep muscle of spine. |
| Control Group | Other | Other: Standard RehabilitationIn this group the investigators use standard physiotherapy without ultrasonography as biofeedback. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Standard RehabilitationStandard 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. | Other | Biofeedback Group, Control Group |
| Biofeedback UltrasonographyBiofeedback 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. | Other | Biofeedback Group |
Primary outcome
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
15 secondary outcomes
Spinal Range of Motion
Time frame: First examination - before the start of the rehabilitation program
Spinal Range of Motion
Time frame: Second examination - at the end of the eight-week program
Spinal Range of Motion
Time frame: Follow-up assessment at 3 months post-intervention.
Physical activity level
Time frame: First examination - before the start of the rehabilitation program
Physical activity level
Time frame: Second examination - at the end of the eight-week program
Physical activity level
Time frame: Follow-up assessment at 3 months post-intervention.
Stress level
Time frame: First examination - before the start of the rehabilitation program
Stress level
Time frame: Second examination - at the end of the eight-week program
Stress level
Time frame: Follow-up assessment at 3 months post-intervention.
Quality of life questionnaire
Time frame: First examination - before the start of the rehabilitation program
Quality of life questionnaire
Time frame: Second examination - at the end of the eight-week program
Quality of life questionnaire
Time frame: Follow-up assessment at 3 months post-intervention.
Risk of developing chronic low back pain
Time frame: First examination - before the start of the rehabilitation program
Risk of developing chronic low back pain
Time frame: Second examination - at the end of the eight-week program
Risk of developing chronic low back pain
Time frame: Follow-up assessment at 3 months post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Krystian Mleczko, MSc in Physiotherapy principal investigator
University of Rzeszow, Medical and Rehabilitation Center in Tarnów Reha Medica, Tarnow
Agnieszka Guzik, Professor study chair
University of Rzeszow
Agnieszka Wolan-Nieroda, PhD study chair
University of Rzeszow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Rehabilitation and Biofeedback Ultrasonography in people with Low Back Pain and Chronic Low Back Pain, run by University of Rzeszow at 1 site in Poland.
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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 7 Apr 2026. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Krystian Mleczko, MSc in Physiotherapy (+48 781839950, krystianmleczko99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: First examination - before the start of the rehabilitation program). The study lists 12 primary outcomes in all. 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 7 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.