Ultrasound-guided stabilization exercises for lumbosacral (low back) pain
Evaluation of the Effectiveness of Stabilization Training With Biofeedback in Patients With Lumbosacral Spine Pain Syndrome
This trial will try using ultrasound biofeedback during stabilization exercises to see if it reduces pain and improves balance, mobility, and quality of life in adults aged 30–65 with chronic lumbosacral (low back) pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | All |
| Sponsor | University of Rzeszow Academic / other |
| Locations | 1 site (Tarnów, Małopolska) |
| Trial ID | NCT07463729 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, controlled intervention comparing standard rehabilitation with stabilization exercises to the same program augmented by rehabilitative ultrasound biofeedback. About 110 patients with chronic lumbosacral pain (≥3 months) will be randomized 1:1 at REHA MEDICA in Tarnów, Poland. Both groups receive manual therapy, selected physical modalities, and exercise programs, with the experimental arm performing stabilization exercises under ultrasound biofeedback and the control arm performing identical exercises without biofeedback. Outcomes measured at baseline, post-intervention, and three months include pain intensity, disability, spinal range of motion, balance via force platform, physical activity, stress level, and self-reported quality of life.
Who should consider this trial
Good fit: Adults 30–65 years old with chronic lumbosacral pain for at least 3 months, VAS >3 and Keele STarT Back score >4, not currently in another rehabilitation program, and able to give written informed consent.
Not a fit: Patients in an acute pain phase or those with neurological deficits (significant sensory loss, motor weakness, sphincter dysfunction), recent spine/pelvic fractures, confirmed segmental instability, high-grade spondylolisthesis, or major coexisting neurological/systemic disease are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, ultrasound biofeedback could help people with chronic low back pain achieve greater pain relief, improved balance and mobility, and longer-lasting functional gains compared with standard rehabilitation.
How similar studies have performed: Smaller randomized and pilot studies using ultrasound biofeedback for lumbar stabilization have shown promising improvements in motor control and function, but findings are mixed and larger confirmatory trials are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tarnów, Małopolska
- Medical and Rehabilitation Center in Tarnów Reha Medica — Tarnów, Małopolska, Poland (Recruiting)
Study contacts
- Principal investigator: Krystian Mleczko, MSc in Physiotherapy — University of Rzeszow, Medical and Rehabilitation Center in Tarnów Reha Medica, Tarnow
- Study coordinator: Krystian Mleczko, MSc in Physiotherapy
- Email: krystianmleczko99@gmail.com
- Phone: +48 781839950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.