Dextrose prolotherapy injected into acupuncture points for chronic non-specific low back pain

Efficacy of Prolotherapy in Acupoints in Chronic Non-specific Low Back Pain (cLBP) - A Randomized Control Trial

This trial will test whether injections of 15% dextrose with 1% lidocaine into acupuncture points help people with chronic non-specific low back pain more than injections of 1% lidocaine alone.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 35 Years and up
• Sex: All
• Sponsor: National and Kapodistrian University of Athens (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Athens, Attica)
• Trial ID: NCT07296653 on ClinicalTrials.gov

What this trial studies

This single-blind, randomized controlled trial will enroll 60 adults with chronic non-specific low back pain and randomly assign them to receive injections of 15% dextrose plus 1% lidocaine or 1% lidocaine alone into predefined acupuncture points. Treatments are delivered in outpatient sessions at a single center and patients will be blinded to group assignment where possible. The study will measure pain and functional outcomes over follow-up to see whether adding hypertonic dextrose (prolotherapy) provides superior or longer-lasting relief. Eligibility allows BMI up to 45 kg/m2 and excludes patients with specific structural spinal disease or neurological deficits.

Who should consider this trial

Good fit: Adults with chronic non-specific low back pain lasting more than three months, without clear structural spinal pathology on imaging, and with BMI up to 45 kg/m2 are the intended participants.

Not a fit: Patients with identifiable spinal pathology (such as severe spinal stenosis, radiculopathy with neurological deficits), recent spine surgery, infection, or other conditions requiring specific anatomical interventions are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could provide longer-lasting, low-risk pain relief and improved function with a minimally invasive outpatient injection.

How similar studies have performed: Previous studies have reported some pain-relief effects for both dextrose prolotherapy and acupuncture, but combining prolotherapy targeted to acupuncture points is relatively novel and not yet well-established.

Eligibility criteria

Inclusion Criteria:

* Body Mass Index (BMI) up to 45 kg/m2
* Diagnoses corresponding to \>1 of the following ICD-10 (International Classification of Diseases):

  1. M51.3 Degeneration of intervertebral discs
  2. M54.5 Low back pain
  3. M54.8 Other forms of back pain
  4. M54.9 Various forms of back pain
  5. S33.5 Sprain of the lumbar spine
  6. S33.6 Sprain of sacroiliac joint
  7. S33.7 Sprain of other and various parts of lumbar spine and pelvis
* Diagnosis of chronic nonspecific low back pain: Chronic nonspecific low back pain refers to pain in the lower back with or without radiation to the lower extremities, lasting for more than 3 months and not attributable to a specific anatomical structure or pathology on imaging, for example generalized degenerative changes, but no pathological findings (such as spinal stenosis or disorders of the sagittal/coronal architecture or intervertebral foramen stenosis) with neurological deficits and no symptoms specific to the predominant pathology.
* Numerical Rating Scale (NRS) \> 3/10 for at least 3 months prior to the study
* Positive response to \>1 muscle strength assessment tests in chronic low back pain A. prone plank bridge test (PBT) B. side bridge test (SBT) C. supine bridge test (SUBT) D. Range of Motion (ROM) E. Back Performance Scale (BPS) F. Straight leg raise test (SLR)
* Pain, inability to walk, and stiffness in the lumbar spine, persisting for at least three months prior to the study.
* Radiological imaging tests such as MRI or CT and, in cases of clinical suspicion (where appropriate), X-rays with dynamic flexion/extension or whole spine X-rays.
* Signing of written consent prior to the injection of pharmaceutical agents.

Exclusion Criteria:

* 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
* History of the following diseases:

  1. connective tissue disease affecting the intervertebral spaces
  2. insulin-dependent diabetes mellitus without adequate control
  3. acute lumbosacral radiculopathy or peripheral neuropathy
  4. neurological/psychiatric disease
  5. history of malignancy in the area or any other active malignancy in the body
  6. Bleeding disorder
  7. Trauma during the previous three months without imaging investigation
  8. Systemic diseases such as rheumatic diseases
  9. Known abdominal aortic aneurysm
* Pregnancy (based on history)
* History of allergy to local anesthetics
* Needle phobia
* Inability to communicate adequately, severe hearing loss, language problems, dementia
* Inability to guarantee transportation to the hospital for treatments/follow-up examinations

Where this trial is running

Athens, Attica

• University General Hospital of Athens "Attikon" - National and Kapodistrian University of Athens Medical School — Athens, Attica, Greece (Recruiting)

Study contacts

• Study coordinator: Konstantinos Kalimeris MD, PhD, Associate Professor of Anesthesiology, Associate Professor

Conditions Chronic Non-specific Low Back Pain; prolotherapy; acupoints; dextrose; low back pain