Prevention and treatment of thoracolumbar myofascial pain in adult patients with acute and chronic non-specific spinal pain. Musculoskeletal Diseases
Conditions
Interventions
Methodology summary
The study is designed as a prospective, randomized controlled trial (RCT) with an additional within-subject comparative component evaluating the effects of hydration status and bo
Sponsors
Provita Medical Centre
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18–65 years. 2. Presence of myofascial pain in the thoracolumbar or lumbar spine region. 3. Duration of symptoms: =3 months (chronic pain) or =7 days (acute pain, depending on the study arm). 4. Pain intensity of at least 4/10 on the NRS within the last week. 5. Presence of myofascial symptoms (e.g., trigger points or soft tissue tenderness). 6. No signs of radiculopathy or serious spinal pathology. 7. Stable clinical condition with no changes in pain-related pharmacological treatment within the last 4 weeks. 8. Ability to participate in study procedures and understand instructions. 9. Signed informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Signs of serious spinal pathology (e.g., malignancy, infection, fractures, inflammatory spinal diseases, cauda equina syndrome, progressive neurological deficits). Symptoms of radiculopathy (e.g., radiating pain below the knee, dermatomal paresthesia, positive neurological tension tests). 2. History of spinal surgery within the last 12 months or presence of spinal implants. 3. Recent musculoskeletal injury of the spine, pelvis, or soft tissues (<6 months). 4. Neurological disorders affecting pain perception or motor control (e.g., Parkinson’s disease, multiple sclerosis, peripheral neuropathies). 5. Rheumatologic or systemic inflammatory diseases (e.g., rheumatoid arthritis, ankylosing spondylitis). 6. Severe uncontrolled systemic diseases (e.g., cardiovascular, respiratory, or uncontrolled hypertension). 7. Interventional spine pain treatments within the last 3 months (e.g., steroid injections, nerve blocks, radiofrequency procedures). 8. Participation in intensive physiotherapy for the spine within the last 4 weeks. 9. Contraindications to manual therapy (e.g., acute soft tissue inflammation, skin conditions, severe osteoporosis). 10. Pregnancy. 11. Participation in another clinical trial within the last 3 months. 12. Lack of consent or withdrawal of consent at any stage of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Thoracolumbar fascia stiffness measured using shear wave elastography (SWE) in kilopascals (kPa) at T0 (baseline), T1 (immediately after intervention), T2 (follow-up), and T3 (extended follow-up);Pain intensity measured using the Visual Analog Scale (VAS) in millimeters (mm) and the Numeric Rating Scale (NRS, 0–10) at T0, T1, T2, and T3;Pressure pain threshold measured using digital pressure algometry in kilograms per square centimeter (kg/cm²) at T0, T1, T2, and T3;Functional disability measured using the Oswestry Disability Index (ODI) expressed as a percentage (%) at T0, T1, T2, and T3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Thoracolumbar fascia thickness measured using B-mode ultrasonography in millimeters (mm) at T0, T1, T2, and T3;Biomechanical tissue properties measured using the MyotonPRO device (frequency in Hz, stiffness in N/m, elasticity as log decrement) at T0, T1, T2, and T3;Microcirculation measured using laser Doppler flowmetry in perfusion units (PU) at T0, T1, T2, and T3;Spinal range of motion measured using inclinometer or goniometer in degrees (°) at T0, T1, T2, and T3;Hydration status measured using bioelectrical impedance analysis (BIA) and urine specific gravity test strips at T0 (baseline), before and after hydration, and during positional assessments | — |
Countries
Poland
Contacts
Public ContactBeata;Robert Borecka;Trybulski
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Outcome results
None listed