NCT07439874

Genetic Alterations From Physical Therapy in Low Back Pain and Disc Degeneration

Genetic Alterations Induced by the Physical Therapy Intervention in the Pathogenesis of Low Back Pain and Intervertebral Disc Degeneration of Tabuk Population, Saudi Arabia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University of Tabuk · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Genetic Alteration
• Low Back Pain
• Physiotherapy

Interventions

Type	Name	Description
DEVICE	Interferential therapy	Applied to lumbar region; standard protocol \[specify frequency, intensity, duration per session\]
DEVICE	Interferential therapy	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

Timeline

• Start date: 2024-08-15
• Primary completion: 2025-03-25
• Completion: 2026-01-15
• First posted: 2026-02-27
• Last updated: 2026-03-03

Locations

1 site across 1 country: Saudi Arabia