Exercise therapy for chronic low back pain.
Jill A Hayden, Jenna Ellis, Rachel Ogilvie...
https://pubmed.ncbi.nlm.nih.gov/34580864/Actively Recruiting
Led by National and Kapodistrian University of Athens · Updated on 2025-12-22
60
Participants Needed
1
Research Sites
8 weeks
Total Duration
Chronic non-specific low back pain CNSLBP is a common and disabling condition that often does not respond well to standard treatments like medications and physical therapy. This research evaluates whether combining prolotherapy using a 15% dextrose solution with 1% lidocaine injections at specific lumbar acupuncture points is more effective than using lidocaine injections alone. The trial is a single-blind randomized controlled study aiming to improve pain and function in adults with CNSLBP. Participants will be randomly assigned to one of two groups one receiving injections of dextrose plus lidocaine, and the other receiving lidocaine only. Each participant will undergo up to 15 ultrasound-guided injections at standardized acupuncture points in the lumbar region during three sessions spaced over four weeks. The study uses precise injection techniques and standardized locations to assess the added value of dextrose in prolotherapy. Throughout the study, participants will complete assessments of pain severity, disability, and physical function using various validated tools at baseline and multiple follow-up points up to 90 days post-treatment. Safety will be monitored by recording any injection-related side effects. The study will provide detailed information on the effectiveness and tolerability of the treatments, with total participation lasting several months including treatment and follow-up visits.
CONDITIONS
Prolotherapy in Acupoints in Chronic Non-specific Low Back Pain (cLBP)
K
Konstantinos Kalimeris MD, PhD, Associate Professor of Anesthesiology, Associate Professor
I
Ioannis Evgenidis MD, MSc, MBA, PhD candidate
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National and Kapodistrian University of Athens
Lead Sponsor
Attikon Hospital
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive three injection sessions of either combinational prolotherapy or local anesthetic injections at standardized lumbar acupuncture points.
3 visits (in-person) at baseline, 2 weeks, and 4 weeks
Duration - Up to 3 months after last injection
Participants attend follow-up visits to assess pain, function, and safety after completion of injections.
3 visits (in-person) at 15, 30, and 90 days post-treatment
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor
Attikon Hospital
Collaborating Sponsor