Evaluation of Stabilization Training With Biofeedback in Lumbosacral Spine Pain Syndrome

Condition(s) studied

Investigational drug(s) / intervention(s)

Standard Rehabilitation: 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: 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 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.

Eligibility

Primary outcome measure(s)

• Balance — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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.

Trial sites (1)

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