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A Double-Blind Randomized Controlled Trial of Polydeoxyribonucleotide Injection into the Thoracolumbar Fascia under Ultrasound Guidance for the Treatment of Low Back Pain in Adults

A Double-Blind Randomized Controlled Trial of Polydeoxyribonucleotide Injection into the Thoracolumbar Fascia under Ultrasound Guidance for the Treatment of Low Back Pain in Adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104909
Enrollment
Unknown
Registered
2025-06-25
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low back pain

Interventions

PDRN group:Intramuscular injection of 3 mL PDRN into the thoracolumbar fascia once a week for three consecutive weeks
home-based lumbar and back muscle exercises.
Placebo group:Intrathoracolumbar fascia injection of 3 ml of 0.9% sodium chloride injection once a week for three consecutive weeks

Sponsors

The First Affiliated Hospital of Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for myofascial low back pain; 2. Moderate to severe pain, with a Visual Analog Scale (VAS) score > =4; 3. Patients are aged between 18 and 65 years; 4. Duration of symptoms exceeds one month; 5. Patients have a thorough understanding of the study content, with good compliance and high level of cooperation; 6. Informed consent has been signed.

Exclusion criteria

Exclusion criteria: 1. Low back pain caused by any other reasons, including but not limited to lumbar disc herniation, lumbar spinal stenosis, ankylosing spondylitis, spinal tumors, spinal tuberculosis, spinal cord infections, etc.; 2. Patients with severe diabetes or drug allergies; 3. Patients with fever, upper respiratory tract infections, or other infectious diseases; 4. Patients with systemic diseases or organ dysfunction; 5. Patients with coagulation disorders or those taking anticoagulant medications; 6. Patients with infections of the injection site or surrounding soft tissues; 7. Patients currently using corticosteroids or undergoing other treatments that may affect the observation indicators of this study; 8. Patients with severe mental illness who cannot cooperate; 9. Pregnant or breastfeeding women.

Design outcomes

Primary

MeasureTime frame
Visual analogue scale,VAS;Medical Outcom Study 36-Item Short-Form Health Survey, SF-36;

Secondary

MeasureTime frame
OswestryDisability Index, ODI ;

Countries

China

Contacts

Public ContactGao bo

The First Affiliated Hospital of Air Force Medical University

gaobofmmu@hotmail.com+86 135 7280 1499

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026