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临床试验/NCT07439874
NCT07439874已完成不适用

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

University of Tabuk1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年8月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Numerical pain rating scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Skeletal deformities
  • Rheumatologic conditions
  • Progressive motor weakness
  • Incontinence
  • A history of cancer Use of systemic medications and illnesses Fractures.

研究组 & 干预措施

Physiotherapy Treatment

Experimental

60 CLBP patients were randomized (30 per arm). Group A received physiotherapy only

干预措施: Interferential therapy (Device)

Physiotherapy and Vitamin D Supplementation

Experimental

60 CLBP patients were randomized (30 per arm) Group B received physiotherapy and Vitamin D supplementation

干预措施: Interferential therapy (Device)

结局指标

主要结局

Numerical pain rating scale

时间窗: 6 weeks

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

Arabic Oswestry Disability Scale

时间窗: 6 weeks

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

次要结局

  • Inflammatory biomarkers-IL-6(6 weeks)
  • Vitamin D Parameters(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shahul Hameed Pakkir Mohamed

Associate Professor

University of Tabuk

研究点 (1)

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