💬In plain words
What the trial is, and whether it could suit you
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 CNS
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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