Condition: Chronic Non-specific Low Back Pain · Sponsor: National and Kapodistrian University of Athens
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. O…
This description comes directly from the study's public registry record.
Konstantinos Kalimeris MD, PhD, Associate Professor of Anesthesiology, Associate Professor · +302105831997 · kkalimeris@med.uoa.gr
Ioannis Evgenidis MD, MSc, MBA, PhD candidate · +30 6979872857 · jean.evgenidis@gmail.com
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| University General Hospital of Athens "Attikon" - National and Kapodistrian University of Athens Medical School | Athens, Attica, Greece | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07296653