Genetic Alteration, Low Back Pain, Physiotherapy
Conditions
Keywords
Chronic low back pain, Physiotherapy, Vitamin D Supplementation, Interleukin-6
Brief 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.
Interventions
DEVICEInterferential therapy
Applied to lumbar region; standard protocol \[specify frequency, intensity, duration per session\]
Sponsors
University of Tabuk
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Intervention model description
Physiotherapy: one group received interferential therapy and exercises, and the other group received physiotherapy and vitamin D supplementation prescribed by the physician
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical pain rating scale | 6 weeks | Patients assess their pain on an 11-point scale from 0-10 |
| Arabic Oswestry Disability Scale | 6 weeks | A self-assessment tool used to evaluate physical disability. It has been utilized specifically to measure disability related to back pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory biomarkers-IL-6 | 6 weeks | IL-6 is a pro-inflammatory cytokine that is significantly elevated in individuals with CLBP, particularly in those with intervertebral disc degeneration |
| Vitamin D Parameters | 6 weeks | Low vitamin D levels are associated with increased pain severity, elevated disability scores, and poorer treatment outcomes in populations suffering from LBP |
Countries
Saudi Arabia
Outcome results
None listed