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.
Body Mass Index (BMI) up to 45 kg/m2
M51.3 Degeneration of intervertebral discs
M54.5 Low back pain
M54.8 Other forms of back pain
Any infection of the skin of the lumbar spine area, such as cellulitis, or periarticular or intra-articular infection or spondylodiscitis during the last 3 months
History of periarticular or intra-articular injection in the LMS with corticosteroids, local anesthetic, hyaluronic acid, radiofrequency application, electroacupuncture, or prolotherapy within the last three months.
Previous surgery (e.g., spinal fusion) in the LMS
Oral corticosteroids for low back pain or uncontrolled opioids
Parallel
Dextrose 15% and lidocaine 1% infiltration
DrugInfiltration of back acupoints
Lidocaine 1% infiltration
DrugInfiltration of dextrose and lidocaine in back acupoints
Pain severity score 15 days after completion of the intervention
Pain severity score from the short Brief Pain Inventory (BPI) form, 15 days after completion of the infiltrations. Minimum value: 0 and Maximum value: 10 Higher scores correspond to worse outcome - i.e. greater pain severity or greater interference with functioning.
Pain severity score at 90 days after completion of the therapy
Pain severity score from BPI short form 90 days after completion of the infiltrations.
Oswestry disability index (ODI) at baseline, 15, 30 and 90 days after completion of therapy
Oswestry scale score
Short term changes after the first infiltration
Pain decrease, duration of analgesia and optimism at 24 hours (Day 1) after completion of the first session. Pain reduction after the first session will be analyzed as prognostic factor for the pain improvement.
TUG (timed up and go) test
TUG test in seconds at baseline, 15 minutes before and after 1st Infiltration and Day 15, Day 30, and Day 90 after the 3rd infiltration
Subanalyses of the scales measured
Subanalyses of questions from the above mentioned scales (BPI + Oswestry Disability Index + Rolland + TUG + ΝRS + Global Impression of Change) eg. usage of analgesics, changes in life attitudes, changes in movement/work/food habits, undergoing other parallel treatments or hospitalizations
Click on the lead sponsor to view all of their trials.
National and Kapodistrian University of Athens
Lead sponsor
Attikon Hospital
Collaborator
