The effect of fascial manipulation on pain and mechanical properties of the thoracolumbar fascia in patients with chronic nonspecific myofascial pain of the thoracolumbar spine
Prevention and treatment of thoracolumbar myofascial pain in adult patients with acute and chronic non-specific spinal pain.
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 body position on the mechanical properties of the thoracolumbar fascia. A total of 120 participants are enrolled, with approximately N = 30 participants per group. Participants are recruited from outpatient physiotherapy clinics. After eligibility assessment and baseline measurements, participants are randomly allocated to study groups using a computer-generated block randomization sequence with allocation concealment. Randomization is performed in a 1:1 or 1:1:1 ratio depending on the study component. The study includes three interventional components. In the chronic pain component (two-center study), participants are assigned to: the FM group (Fascial Manipulation), receiving standardized fascial therapy, and the EX group (exercise therapy), receiving movement-based physiotherapy including spinal stabilization exercises, functional exercises, and patient education. In the combined therapy component, participants are assigned to: the FM+DN group (Fascial Manipulation combined with dry needling), the FM+sham DN group (Fascial Manipulation with sham dry needling), and the DN+sham FM group (dry needling with sham Fascial Manipulation). In the acute pain component, participants are assigned to: the FM group (active therapy) and the sham FM group (placebo manual intervention involving non-therapeutic contact). Each group includes approximately 30 participants. Interventions are delivered by licensed physiotherapists trained in the study protocol. Fascial Manipulation is performed using a standardized procedure including functional assessment, identification of fascial points, and application of deep fascial friction, sustained pressure, fascial stretching, and gliding techniques. Dry needling is applied to myofascial trigger points using sterile, single-use filiform ne
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.
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.