Evaluation of Stabilization Training With Biofeedback in Lumbosacral Spine Pain Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorUniversity of Rzeszow
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Standard Rehabilitation
Other interventionStandard 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 interventionBiofeedback 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.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Biofeedback GroupExperimental treatment 2 interventions
Group B: Control GroupOther 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
First examination - before the start of the rehabilitation program2
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
Time frame
Second examination - at the end of the eight-week program3
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
Time frame
Follow-up assessment at 3 months post-intervention.4
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.
Time frame
First examination - before the start of the rehabilitation programSecondary outcomes
1
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.
Time frame
First examination - before the start of the rehabilitation program2
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.
Time frame
Second examination - at the end of the eight-week program3
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.
Time frame
Follow-up assessment at 3 months post-intervention.4
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.
Time frame
First examination - before the start of the rehabilitation programSponsors and contacts
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Source ClinicalTrials.gov