Effects Of 8-Week Core Stabilization Exercise With Vitamin D On Pain and Functional Limitation in Adults

Effects Of 8-Week Core Stabilization Exercise With Vitamin D On Pain and Functional Limitation in Adults With Chronic Non-Specific Low Back Pain

Chronic non-specific low back pain (CNSLBP) is a prevalent condition contributing to pain, functional limitations, and reduced quality of life. Core stabilization exercises (CSE) have shown promise in enhancing spinal stability and reducing symptoms. Additionally, vitamin D supplementation plays a critical role in musculoskeletal health. Study objective will be to determine combined effect of vitamin D supplementation and core Stabilization exercises is better than core Stabilization Exercises alone in reducing pain-related and functional independence among chronic non-specific low back patient A randomized controlled trial will be conducted on 52 adults aged 25-45 diagnosed with Chronic non-specific low back pain.

Study Overview

• Status: Active, not recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Combination product: core stabilization exercise; Diagnostic test: stabilization exercise

Detailed Description

Subjects will be divided into two groups: the intervention group will receive an 8-week Core stabilization exercises program alongside daily vitamin D supplementation, while the control group will receive either Core stabilization exercises alone Visual Analog Scale (VAS), and Oswestry Disability

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Sialkot, Punjab, Pakistan
      • Shoukat Hospital Near Session Court Jhang Road Chiniot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 25 to 45 years will be included.
• Both gender Male /Female will participate.
• Subjects with diagnosed non-specific low lumber pain persisting for at least 12 weeks will be included.
• Subjects must have baseline pain score of ≥4 on the Visual Analog Scale.
• Confirmed serum vitamin D levels <30 ng/m will be included

Exclusion Criteria:

• Low lumber pain due to specific causes such as fracture malignancy infection or inflammatory diseases (e.g. ankylosing spondylitis).
• Presence of significant comorbidities that could interfere with participation (e.g. cardiovascular neurological or respiratory disorders).
• History of spinal surgery within the last year.
• Subjects currently taking vitamin D supplements or undergoing other treatments for vitamin D deficiency.
• Use of medications such as corticosteroids or opioids that might affect pain perception or functional assessment.
• Enrolled in any other physical therapy or pain management program within the last three months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: core stabilization exercise	Combination product: core stabilization exercise; Will receive 8 week core stabilization exercise 3 session per week which include 10 min warm up and 10 min cool down (walking ) 6 sets of movements co contraction of abdominal muscles (Abdominal hollowing) ,bridging ,dead bug ,plank with 50,000 IU of vitamin D weekly
Active Comparator: stabilization exercise	Diagnostic test: stabilization exercise; stabilization exercise 3 session per week which include 10 min warm and 10 min cool down (walking ) sham medicine, 6 sets of movements co contraction of abdominal muscles (Abdominal hollowing) ,bridging ,dead bug and plank

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Visual Analogue Scale (VAS)	The Visual Analogue Scale (VAS) uses a 10 cm line with anchors like "no pain" and "worst pain imaginable", and the score is determined by measuring the distance (in mm or cm) from the "no pain" end to the patient's mark, ranging from 0 to 100	12 Months
The Oswestry Disability Index (ODI)	The Oswestry Disability Index (ODI) is a questionnaire used to assess functional disability in individuals with low back pain, with scores ranging from 0% (no disability) to 100% (maximum disability), and interpreted as follows: 0-20% minimal disability, 21-40% moderate, 41-60% severe, 61-80% crippling, and 81-100% bed-bound or exaggerated symptoms	12 Months

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2025
• Primary Completion (Estimated): June 20, 2025
• Study Completion (Estimated): February 20, 2026

Study Registration Dates

• First Submitted: March 29, 2025
• First Submitted That Met QC Criteria: March 29, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: March 29, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: MSRSW/Batch-Fall23/796

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No