NCT07463729 Evaluation of Stabilization Training With Biofeedback in Lumbosacral Spine Pain Syndrome
| NCT ID | NCT07463729 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Rzeszow |
| Condition | Low Back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2026-04-01 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 * Provision of written informed consent to participate in the study Exclusion Criteria: * 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) * Spondylolisthesis greater than Grade I according to the Meyerding classification * Coexisting neurological (e.g., Parkinson's disease, neuropathies), autoimmune (e.g., ankylosing spondylitis), orthopedic (lower limb disorders), or oncological diseases * Pregnancy * Active use of analgesic or anti-inflammatory pharmacotherapy (e.g., steroids, NSAIDs) * Concurrent participation in other rehabilitation programs or failure to complete the 8-week therapy program * Completion of any structured rehabilitation program within the past 3 months * Lack of informed consent to participate in the study
Contact & Investigator
Krystian Mleczko, MSc in Physiotherapy
PRINCIPAL INVESTIGATOR
University of Rzeszow, Medical and Rehabilitation Center in Tarnów Reha Medica, Tarnow
Frequently Asked Questions
Who can join the NCT07463729 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 65 Years, studying Low Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07463729 currently recruiting?
Yes, NCT07463729 is actively recruiting participants. Contact the research team at krystianmleczko99@gmail.com for enrollment information.
Where is the NCT07463729 trial being conducted?
This trial is being conducted at Tarnów, Poland.
Who is sponsoring the NCT07463729 clinical trial?
NCT07463729 is sponsored by University of Rzeszow. The principal investigator is Krystian Mleczko, MSc in Physiotherapy at University of Rzeszow, Medical and Rehabilitation Center in Tarnów Reha Medica, Tarnow. The trial plans to enroll 110 participants.