Evaluation of Stabilization Training With Biofeedback in Lumbosacral Spine Pain Syndrome

Sponsor
University of Rzeszow
Study ID
NCT07463729
Status
Recruiting
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Conditions

  • Chronic Low Back Pain
  • Low Back Pain

Eligibility Criteria

Sex
ALL
Age
30 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Standard Rehabilitation — OTHER
    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 — OTHER
    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 Details

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.

Key Dates

First listed
Mar 11, 2026
Start date
Apr 1, 2026
Status verified
Mar 2026
Primary completion
May 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Biofeedback Group
    The investigators use in this group standard physiotherapy and ultrasonography as Biofeedback-Assisted Stabilization Training to activate deep muscle of spine.
  • Other: Control Group
    In this group the investigators use standard physiotherapy without ultrasonography as biofeedback.

Primary Outcome Measure

Balance [ Time Frame: First examination - before the start of the rehabilitation program ]

Central Contacts

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