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

Background and Rationale Chronic non-specific low back pain (CNSLBP) is among the most prevalent and disabling musculoskeletal conditions in the world, with approximately 60-80% of individuals developing it at some point during their lifetime. Unlike specific etiologies for back pain, e.g., fracture, infection, or radiculopathy, CNSLBP has no explicitly diagnosable pathological or structural cause. Yet, it often leads to chronic pain, functional disability, and reduced quality of life. The economic burden of CNSLBP extends beyond the patient, with high socioeconomic costs in healthcare consumption, lost productivity, and disability-related absenteeism. Despite extensive use of conventional treatments, e.g., pharmacologic treatments, physiotherapy, and interventions, most patients are only temporarily or partially relieved, indicating an urgent requirement for an improved long-term management regimen.

Traditional Western medical interventions have a proclivity to address inflammatory or structural causes, and conventional pharmacotherapy generally provides transient symptom relief of limited duration. NSAIDs, muscle relaxants, and opioids can abate acute symptoms but are side-affected and of little long-term efficacy. Similarly, interventional therapies, i.e., epidural steroid injection or radiofrequency ablation, may be targeted at specific anatomical structures but do not address the multifactorial causation of CNSLBP and resultant recurrence or chronicity of pain. Complementary treatments, e.g., exercise, cognitive behavior therapy, and acupuncture, are inconsistently effective, and integration into mainstream clinical practice is frequently disrupted by complexity, cost, or the need for special training.

Prolotherapy, or proliferative therapy, is a new regenerative therapy for chronic musculoskeletal pain. Hypertonic dextrose solution injections near ligaments, tendons, and periarticular tissue is postulated to enhance local repair of tissue, collagen production, and modulation of neurogenic inflammation in dextrose prolotherapy. Targeted injections, based on recent studies, reduce pain and improve function, particularly in chronic low back pain that is resistant to conventional treatment. Of note, many of the anatomic sites treated with prolotherapy are also points for acupuncture, which have been shown to influence neurovascular physiology, endogenous opioid release, and pain modulatory systems. This overlap provides a unique venue for the convergence of the mechanistic benefits of both interventions.

Despite encouraging early findings, few studies have assessed the efficacy of prolotherapy in patients with CNSLBP systematically. There is not much evidence to support prolotherapy; that's why it has not been widely practiced. The treatment site is also non-uniform. This is why we would like to conduct this study, as a way of finding out whether the protocol of prolotherapy to and from universally recognized lumbar acupoints can provide clinically meaningful reductions in pain severity and improvement in functional capability, and thus address a highly important unmet need in the treatment of chronic low back pain.

Study Objectives and Hypotheses The primary study objective is to determine the clinical effectiveness of combinational prolotherapy injectate delivered to standardized acupuncture points for the management of adults with chronic non-specific low back pain (CNSLBP). Specifically, we wish to determine whether the intervention has a significant impact on reducing pain intensity and enhancing functional ability compared with the use of local anesthetic injections alone. By stimulating acupoints that correspond to the lumbar region, this approach is designed to combine regenerative, neuromodulatory, and analgesic mechanisms that may offer a more comprehensive solution for those who remain symptomatic despite conventional therapies.