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

NCT06913413 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall23/796
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

core stabilization exercise

EXPERIMENTAL

Combination Product: core stabilization exercise

stabilization exercise

ACTIVE COMPARATOR

Diagnostic Test: stabilization exercise

Interventions

core stabilization exercise COMBINATION_PRODUCT

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

core stabilization exercise

stabilization exercise DIAGNOSTIC_TEST

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

stabilization exercise

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Shoukat Hospital Near Session Court Jhang Road Chiniot

Sialkot, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: April 6, 2025
• Study Start: March 20, 2025
• Primary Completion: June 20, 2025
• Study Completion: February 20, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)