Genetic Alterations Induced by the Physical Therapy Intervention in the Pathogenesis of Low Back Pain and Intervertebral Disc Degeneration of Tabuk Population, Saudi Arabia
| Registry | NCT07439874, acronym Low back pain |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 200 (Actual) |
| Sponsor | University of Tabuk (Other) |
| Conditions | Genetic Alteration, Low Back Pain, Physiotherapy |
| Interventions | Interferential therapy (Device) |
| Dates | start 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 in Saudi Arabia |
Related Papers Related Patents Related Grants Related Experts
All trials for Genetic Alteration All trials for Low Back Pain All trials of Interferential therapy
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Physiotherapy Treatment | Experimental | Device: Interferential therapy | 60 CLBP patients were randomized (30 per arm). Group A received physiotherapy only |
| Physiotherapy and Vitamin D Supplementation | Experimental | Device: Interferential therapy | 60 CLBP patients were randomized (30 per arm) Group B received physiotherapy and Vitamin D supplementation |
Sex: All, ages: 20 Years to 70 Years, accepts healthy volunteers
Inclusion Criteria: * The study involves participants with LBP for more than 3 months. * Both genders, aged 20 to 70 years * Pain intensity of 4 or greater on the Numeric Pain Rating Scale * Capable of understanding and following instructions. Exclusion Criteria: * Skeletal deformities * Rheumatologic conditions * Progressive motor weakness * Incontinence * A history of cancer Use of systemic medications and illnesses Fractures.
| Facility | City | Country | Status |
|---|---|---|---|
| University of Tabuk | Tabuk, Tabuk Region | Saudi Arabia |