NCT07463729

Evaluation of Stabilization Training With Biofeedback in Lumbosacral Spine Pain Syndrome

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: University of Rzeszow · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-05-31
• Completion: 2027-06-30
• First posted: 2026-03-11
• Last updated: 2026-04-07

Locations

1 site across 1 country: Poland