Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test.
A Shumway-Cook, S Brauer, M Woollacott
https://pubmed.ncbi.nlm.nih.gov/10960937Actively Recruiting
Early Phase 1
Age: 35Years +
All Genders
ID07296653
Efficacy of Prolotherapy in Acupoints in Chronic Non-specific Low Back Pain (cLBP) - A Randomized Control Trial
Led by National and Kapodistrian University of Athens · Updated on 2025-12-22
60
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
N
National and Kapodistrian University of Athens
Lead Sponsor
A
Attikon Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Brief Title
Prolotherapy in Acupoints in Chronic Non-specific Low Back Pain (cLBP)
Who Can Participate
Age: 35Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Body Mass Index (BMI) up to 45 kg/m2
- Diagnosed with chronic non-specific low back pain lasting more than 3 months without specific pathological findings
- Numeric Rating Scale (NRS) pain score greater than 3 out of 10 for at least 3 months prior to the study
- Positive response to at least one muscle strength or mobility assessment test related to low back pain
- Availability of radiological imaging such as MRI, CT, or X-rays as appropriate
- Signed written consent prior to injection of pharmaceutical agents
You will not qualify if you...
- Skin or joint infections in the lumbar spine area within the last 3 months
- Recent periarticular or intra-articular injections in the lumbar region within the last 3 months
- Previous lumbar spine surgery such as spinal fusion
- Use of oral corticosteroids for low back pain or uncontrolled opioid use
- History of connective tissue disease, uncontrolled diabetes, radiculopathy, neurological or psychiatric disease, active malignancy, bleeding disorders, or recent trauma without imaging
- Systemic diseases including rheumatic diseases or known abdominal aortic aneurysm
- Pregnancy
- Allergy to local anesthetics
- Needle phobia
- Communication difficulties including severe hearing loss, language problems, or dementia
- Inability to guarantee transportation to treatment and follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
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
Follow-up
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
Trial Site Locations
Total: 1 location
1
University General Hospital of Athens "Attikon" - National and Kapodistrian University of Athens Medical School
Athens, Attica, Greece, 12461
Actively Recruiting
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Research Team
K
Konstantinos Kalimeris MD, PhD, Associate Professor of Anesthesiology, Associate Professor
I
Ioannis Evgenidis MD, MSc, MBA, PhD candidate
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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