Actively Recruiting

Phase Not Applicable
Age: 30Years - 65Years
All Genders
NCT07463729

Evaluation of Stabilization Training With Biofeedback in Lumbosacral Spine Pain Syndrome

Led by University of Rzeszow · Updated on 2026-04-07

110

Participants Needed

1

Research Sites

65 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Evaluation of Stabilization Training With Biofeedback in Lumbosacral Spine Pain Syndrome

Who Can Participate

Age: 30Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed chronic lumbosacral spine pain syndrome with a score above 4 on the Keele STarT Back Screening Tool
  • Lumbosacral pain intensity greater than 3 on the Visual Analog Scale persisting for at least 3 months
  • Age between 30 and 65 years
  • Not currently participating in another rehabilitation program
  • Provided written informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Acute phase of lumbosacral spine pain syndrome
  • Neurological symptoms such as paresthesia, dysesthesia, impaired sensation, muscle strength below grade 3 on the Lovett scale in lower limbs, sphincter dysfunction, or cauda equina syndrome
  • Recent spine or pelvis fractures within the past 6 months
  • Segmental instability confirmed by functional X-ray or MRI
  • Spondylolisthesis greater than Grade I according to Meyerding classification
  • Coexisting neurological, autoimmune, orthopedic, or oncological diseases
  • Pregnancy
  • Active use of analgesic or anti-inflammatory medications such as steroids or 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Medical and Rehabilitation Center in Tarnów Reha Medica

Tarnów, Małopolska, Poland, 33-100

Actively Recruiting

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Research Team

K

Krystian Mleczko, MSc in Physiotherapy

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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