Actively Recruiting
Evaluation of the Effectiveness of Stabilization Training With Biofeedback in Patients With Lumbosacral Spine Pain Syndrome
Led by University of Rzeszow · Updated on 2026-04-07
110
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of stabilization training with biofeedback compared to conventional therapy on patients with chronic lumbosacral spine pain lasting at least three months. The study aims to determine whether this biofeedback-assisted training improves balance, spinal mobility, functional performance, physical activity, quality of life, and reduces pain and stress levels. It also investigates if the therapeutic effects differ based on the treatment method and if benefits are maintained three months after the intervention. Participants will be randomly assigned to one of two groups: an experimental group receiving stabilization exercises aided by ultrasonography biofeedback, and a control group performing the same exercises without biofeedback. Both groups will also receive manual therapy and selected physical therapy modalities including TENS and therapeutic ultrasound. The rehabilitation program lasts eight weeks with two sessions per week, supervised by medical and physiotherapy professionals. Throughout the study, participants will undergo clinical and functional assessments including pain intensity scales, disability indices, spinal range of motion measurements, balance tests using a force platform, physical activity questionnaires, stress scales, and quality of life surveys. Assessments occur before starting the program, immediately after the eight-week intervention, and at a three-month follow-up. The study carefully monitors participants under medical supervision to evaluate the lasting effects of the therapies on lumbosacral spine pain syndrome.
CONDITIONS
Brief Title
Evaluation of Stabilization Training With Biofeedback in Lumbosacral Spine Pain Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed chronic lumbosacral spine pain syndrome with a score greater than 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
- No concurrent participation in another rehabilitation program
- Signed written informed consent to participate in the study
You will not qualify if you...
- Acute phase of lumbosacral spine pain syndrome
- Presence of neurological symptoms such as paresthesia, dysesthesia, impaired sensation, muscle weakness below grade 3 on the Lovett scale in lower limbs, sphincter dysfunction, or cauda equina syndrome
- Recent spine or pelvis fractures within the last 6 months
- Segmental instability confirmed by functional X-ray or MRI
- Spondylolisthesis greater than Grade I by Meyerding classification
- Coexisting neurological, autoimmune, orthopedic, or oncological diseases
- Pregnancy
- Active use of analgesic or anti-inflammatory drugs such as steroids or NSAIDs
- Participation in other rehabilitation programs or failure to complete the 8-week program
- Completion of any structured rehabilitation within the past 3 months
- Lack of informed consent to participate in the study
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for specialist examination and baseline assessments
Duration - 8 weeks
Participants undergo an 8-week physiotherapy program conducted twice weekly. The experimental group receives stabilization training with ultrasonography biofeedback, while the control group receives standard physiotherapy without biofeedback. Both groups receive manual therapy, physical therapy modalities, and therapeutic exercises targeting the lumbosacral spine.
2 sessions per week for 8 weeks (16 sessions total)
Duration - Immediately after the 8-week treatment program
Participants complete a post-treatment assessment that includes evaluation of pain intensity, disability, spinal range of motion, balance, physical activity, stress level, and quality of life, similar to baseline assessments.
1 visit (in-person)
Duration - 3 months post-intervention
Participants return for a follow-up assessment 3 months after completing the therapy to evaluate the maintenance of therapeutic benefits.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Medical and Rehabilitation Center in Tarnów Reha Medica
Tarnów, Małopolska, Poland, 33-100
Actively Recruiting
Research Team
K
Krystian Mleczko, MSc in Physiotherapy
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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