Thoracolumbar fascia mobilization versus ultrasound-guided 5% dextrose injection for chronic low back pain
Comparison of the Effectiveness of Thoracolumbar Fascia Mobilization and Ultrasound-Guided Thoracolumbar Interfascial 5% Dextrose Injection in Patients With Chronic Low Back Pain
This study will try two treatments—hands-on thoracolumbar fascia mobilization and ultrasound-guided 5% dextrose injections—to see if they reduce pain and improve movement and function in adults with chronic low back pain who have not adequately improved with medical treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ankara City Hospital Bilkent Academic / other |
| Locations | 1 site (Ankara, Altındağ) |
| Trial ID | NCT07241559 on ClinicalTrials.gov |
What this trial studies
This randomized interventional trial compares hands-on thoracolumbar fascia mobilization with ultrasound-guided interfascial injections of 5% dextrose in adults who have nonspecific chronic low back pain. Participants are assigned to one of three groups, with the mobilization group receiving standardized myofascial release twice weekly for three weeks and the injection group treated under ultrasound guidance to the thoracolumbar interfascial space. Primary outcomes include pain intensity, lumbar range of motion, and functional disability, while secondary outcomes include quality of life, proprioception, and thoracolumbar fascia thickness and echogenicity. Eligible participants are adults aged 18–65 without prior spinal surgery, radiculopathy, major inflammatory or malignant disease, recent manual therapy or injections, or other exclusionary conditions.
Who should consider this trial
Good fit: Adults aged 18–65 with nonspecific low back pain lasting more than three months who have not had an adequate response to medical treatment and who meet the trial's exclusion criteria are ideal candidates.
Not a fit: Patients with prior spinal surgery, radiculopathy or disc pathology causing nerve root symptoms, spinal stenosis/spondylolysis/spondylolisthesis, BMI over 30, pregnancy, coagulation disorders, recent physical therapy or lumbar injections, local infection, or active inflammatory or malignant disease are unlikely to be eligible or to benefit from these interventions in this trial.
Why it matters
Potential benefit: If successful, these approaches could reduce chronic low back pain and improve mobility, daily function, and quality of life for affected patients.
How similar studies have performed: Smaller randomized and observational studies of dextrose prolotherapy and of myofascial release have shown mixed but sometimes promising results for chronic low back pain, and direct head-to-head comparisons remain relatively limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female patients aged 18 to 65 years 2. Presence of low back pain lasting longer than 3 months 3. No adequate response to medical treatment 4. Voluntary participation in the study Exclusion Criteria: 1. Age below 18 or above 65 years 2. Body mass index (BMI) greater than 30 kg/m² 3. Pregnancy or breastfeeding 4. Presence of coagulation disorders 5. History of spinal surgery 6. Presence of inflammatory or malignant diseases 7. Local infection at the spine or injection site 8. Presence of lumbar disc pathology causing radiculopathy 9. Presence of spinal stenosis, spondylolysis, or spondylolisthesis 10. Participation in physical therapy or any manual therapy within the past 6 months 11. Receiving lumbar injections within the past 6 months 12. History of allergy to injection materials 13. Refusal to participate in the study
Where this trial is running
Ankara, Altındağ
- Ankara Training and Research Hospital — Ankara, Altındağ, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Büşra ALÇIN, Medical Doctor — Ankara Training and Research Hospital
- Study coordinator: Barış NACIR, Professor Doctor
- Email: drbarisnacir@gmail.com
- Phone: +905327278724
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.