RecruitingEarly Phase 1NCT07296653

Prolotherapy in Acupoints in Chronic Non-specific Low Back Pain (cLBP)

Efficacy of Prolotherapy in Acupoints in Chronic Non-specific Low Back Pain (cLBP) - A Randomized Control Trial


Sponsor

National and Kapodistrian University of Athens

Enrollment

60 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Chronic non-specific low back pain (CNSLBP) is among the most prevalent causes of disability on the planet, which often proves to be refractory to conventional pharmacological, interventional, and rehabilitation approaches. Although acupuncture has also shown analgesic effectiveness, its variability and reliance on practitioner skill limit its universal introduction into Western medical practice. Prolotherapy, an emerging regenerative injection treatment with hypertonic dextrose solutions, has been of potential benefit in managing musculoskeletal pain by triggering tissue repair and controlling neurogenic inflammation. Interestingly, several acupuncture points correspond to neuroanatomically relevant sites. This single-blind randomized controlled trial aims to ascertain whether combinational prolotherapy with dextrose 15% and lidocaine 1% is superior to lidocaine 1% in patients with CNSLBP. Sixty patients will be allocated randomly into two equal-sized groups and receive a maximum of 15 ultrasound-guided injections into standardized acupoints of the lumbar area (BL23, BL25, BL31, BL54, GV3, GV4, and Ashi points) during three treatment sessions. Outcomes will be evaluated using the Numeric Rating Scale (NRS), the Oswestry Disability Index (ODI), the TUG (Timed Up and Go) test, the BPI (Brief Pain Inventory) scale, the Rolland-Morris Low Back Pain Disability Questionnaire and the Global Impression of Pain Questionnaire at baseline, and at 15, 30, and 90 days post-treatment. Outcomes should clarify whether dextrose-enhanced prolotherapy provides improved analgesia and functional return in comparison with local anesthetic injection alone. This study can present an uncomplicated, low-cost, and integrative regimen for CNSLBP with significant clinical and socioeconomic implications.


Eligibility

Min Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Dextrose 15% and lidocaine 1% infiltration and a drug called Lidocaine 1% infiltration for people with chronic non-specific low back pain. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDextrose 15% and lidocaine 1% infiltration

Infiltration of back acupoints

DRUGLidocaine 1% infiltration

Infiltration of dextrose and lidocaine in back acupoints


Locations(1)

University General Hospital of Athens "Attikon" - National and Kapodistrian University of Athens Medical School

Athens, Attica, Greece

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NCT07296653


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