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Completed

NCT Number: NCT07439874

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

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.

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Key information

Conditions

Genetic Alteration Back Pain Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Physiotherapy Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tabuk

Tabuk, Tabuk Region, 71491, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interferential therapy

Device

Applied to lumbar region; standard protocol [specify frequency, intensity, duration per session]

Primary outcomes

  1. Numerical pain rating scale

    Time frame: 6 weeks

    Patients assess their pain on an 11-point scale from 0-10

  2. Arabic Oswestry Disability Scale

    Time frame: 6 weeks

    A self-assessment tool used to evaluate physical disability. It has been utilized specifically to measure disability related to back pain

Secondary outcomes

  1. Inflammatory biomarkers-IL-6

    Time frame: 6 weeks

    IL-6 is a pro-inflammatory cytokine that is significantly elevated in individuals with CLBP, particularly in those with intervertebral disc degeneration

  2. Vitamin D Parameters

    Time frame: 6 weeks

    Low vitamin D levels are associated with increased pain severity, elevated disability scores, and poorer treatment outcomes in populations suffering from LBP

Sponsors and collaborators

Lead sponsor

University of Tabuk

Other

Registry information

Official study title

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

Acronym: Low back pain

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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