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New treatment option for Chronic Non-specific Low Back Pain
Official title Prolotherapy in Acupoints in Chronic Non-specific Low Back Pain (cLBP)
ClinicalTrials.gov ID: NCT07296653
What this study is testing
What is Dextrose 15% and lidocaine 1% infiltration?
Dextrose 15% and lidocaine 1% infiltration is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for chronic non-specific low back pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 and older
You may be able to join if
- Body Mass Index (BMI) up to 45 kg/m2
- Diagnoses corresponding to \>1 of the following ICD-10 (International Classification of Diseases):
- M51.3 Degeneration of intervertebral discs
- M54.5 Low back pain
- M54.8 Other forms of back pain
You likely can't join if
- Any infection of the skin of the lumbar spine area, such as cellulitis, or periarticular or intra-articular infection or spondylodiscitis during the...
- History of periarticular or intra-articular injection in the LMS with corticosteroids, local anesthetic, hyaluronic acid, radiofrequency application...
- Previous surgery (e.g., spinal fusion) in the LMS
- Oral corticosteroids for low back pain or uncontrolled opioids
- History of the following diseases:
- connective tissue disease affecting the intervertebral spaces
See the full eligibility criteria
- Body Mass Index (BMI) up to 45 kg/m2
- Diagnoses corresponding to \>1 of the following ICD-10 (International Classification of Diseases):
- M51.3 Degeneration of intervertebral discs
- M54.5 Low back pain
- M54.8 Other forms of back pain
- M54.9 Various forms of back pain
- S33.5 Sprain of the lumbar spine
- S33.6 Sprain of sacroiliac joint
- 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...
- 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...
- 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.
- 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:
- connective tissue disease affecting the intervertebral spaces
- insulin-dependent diabetes mellitus without adequate control
- acute lumbosacral radiculopathy or peripheral neuropathy
- neurological/psychiatric disease
- history of malignancy in the area or any other active malignancy in the body
- Bleeding disorder
- Trauma during the previous three months without imaging investigation
- Systemic diseases such as rheumatic diseases
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Athens, Attica, Greece
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 35 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Athens, Attica, Greece. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.