Background and Scientific Rationale: This prospective randomized controlled trial examines the combined effect of physiotherapy and vitamin D supplementation on pain, disability, interleukin-6 (IL-6) expression, and vitamin D levels in individuals with chronic low back pain (CLBP). The study details the demographic and metabolic profiles of CLBP patients compared to healthy controls, addressing a previously underexplored aspect of chronic musculoskeletal pain therapy. A total of 100 patients with chronic low back pain and 100 healthy controls were enrolled. Sixty patients with chronic low back pain were randomly assigned to either receive physiotherapy alone (which included interferential therapy and exercise) or to undergo physiotherapy combined with vitamin D supplementation over six weeks. The outcomes measured included the Numeric Pain Rating Scale (NPRS), the Arabic Oswestry Disability Index (AODI), serum IL-6 expression, and serum vitamin D levels, assessed at baseline and after the intervention.
Background and Scientific Rationale Chronic low back pain (CLBP), defined as persistent pain in the lumbar region lasting more than 12 weeks, is a leading cause of disability worldwide and represents a significant public health concern. Beyond its musculoskeletal origins, CLBP is increasingly recognized as a condition with substantial systemic inflammatory components. Interleukin-6 (IL-6), a complex pro-inflammatory cytokine, is identified as an elevated biomarker in patients with CLBP, likely contributing to both central and peripheral sensitization mechanisms that sustain chronic pain. Additionally, vitamin D deficiency is frequently observed in individuals suffering from chronic low back pain. Vitamin D receptors are found in musculoskeletal tissues, immune cells, and the central nervous system, and vitamin D plays a role in regulating inflammatory pathways, particularly by suppressing IL-6 production. Despite this molecular intersection, the combined effects of physiotherapy-the cornerstone of non-pharmacological treatment for CLBP-and vitamin D supplementation on IL-6 levels and patient-reported outcomes remain underexplored in prospective controlled studies. This study seeks to fill this evidence gap by (1) characterizing the metabolic and inflammatory profiles of CLBP patients compared to healthy individuals and (2) evaluating whether vitamin D supplementation, when added to physiotherapy, results in better clinical and biochemical outcomes than physiotherapy alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
Applied to lumbar region; standard protocol \[specify frequency, intensity, duration per session\]
Applied to the lumbar region; standard protocol \[specify frequency, intensity, duration per session\] and Vitamin D supplementation-60,000 IU of vitamin D3 tablets weekly for six weeks
University of Tabuk
Tabuk, Tabuk Region, Saudi Arabia
Numerical pain rating scale
Patients assess their pain on an 11-point scale from 0-10
Time frame: 6 weeks
Arabic Oswestry Disability Scale
A self-assessment tool used to evaluate physical disability. It has been utilized specifically to measure disability related to back pain
Time frame: 6 weeks
Inflammatory biomarkers-IL-6
IL-6 is a pro-inflammatory cytokine that is significantly elevated in individuals with CLBP, particularly in those with intervertebral disc degeneration
Time frame: 6 weeks
Vitamin D Parameters
Low vitamin D levels are associated with increased pain severity, elevated disability scores, and poorer treatment outcomes in populations suffering from LBP
Time frame: 6 weeks
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