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

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.

Conditions

• Chronic Non-specific Low Back Pain

Interventions

DRUG

Dextrose 15% and lidocaine 1% infiltration

Infiltration of back acupoints

DRUG

Lidocaine 1% infiltration

Infiltration of dextrose and lidocaine in back acupoints

Sponsors & Collaborators

• Attikon Hospital

  collaborator OTHER

• National and Kapodistrian University of Athens

  lead OTHER

Principal Investigators

• Konstantinos Kalimeris, Assoc Prof of Anesthesiology · National and Kapodistrian University of Athens

• Theodosios Saranteas, Professor of Anesthesiology · National and Kapodistrian University of Athens

• Lampis Stavrinou, Assist Prof of Neurosurgery · National and Kapodistrian University of Athens

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-01

Primary Completion

2026-12-31

Completion

2027-02-28

Countries

• Greece

Study Locations