Evaluation of Stabilization Training With Biofeedback in Lumbosacral Spine Pain Syndrome
NCT07463729 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2026-04-07
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.
Conditions
- Low Back Pain
- Chronic Low Back Pain
Interventions
- 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.
Sponsors & Collaborators
-
University of Rzeszow
lead OTHER
Principal Investigators
-
Krystian Mleczko, MSc in Physiotherapy · University of Rzeszow, Medical and Rehabilitation Center in Tarnów Reha Medica, Tarnow
-
Agnieszka Guzik, Professor · University of Rzeszow
-
Agnieszka Wolan-Nieroda, PhD · University of Rzeszow
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-01
- Primary Completion
- 2027-05-31
- Completion
- 2027-06-30
Countries
- Poland
Study Locations
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