Ultrasound-guided stabilization exercises for lumbosacral (low back) pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.