Genetic Alterations From Physical Therapy in Low Back Pain and Disc Degeneration (Low back pain)

February 27, 2026 updated by: Shahul Hameed Pakkir Mohamed, University of Tabuk

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Tabuk Region
      • Tabuk, Tabuk Region, Saudi Arabia, 71491
        • University of Tabuk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physiotherapy Treatment
60 CLBP patients were randomized (30 per arm). Group A received physiotherapy only
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
Experimental: Physiotherapy and Vitamin D Supplementation
60 CLBP patients were randomized (30 per arm) Group B received physiotherapy and Vitamin D supplementation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks
Numerical pain rating scale
Time Frame: 6 weeks
Patients assess their pain on an 11-point scale from 0-10
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tabuk

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2024

Primary Completion (Actual)

March 25, 2025

Study Completion (Actual)

January 15, 2026

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UT-133-01-2021
  • Research Grant (Other Grant/Funding Number: University of Tabuk, Saudi Arabia)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will be shared based on the request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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