Low Back PainNCT06913413
Effects Of 8-Week Core Stabilization Exercise With Vitamin D On Pain and Functional Limitation in Adults
A study testing core stabilization exercise and stabilization exercise in people with Low Back Pain, run by Superior University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- core stabilization exercise and stabilization exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2025to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shoukat Hospital Near Session Court Jhang Road Chiniot
Sialkot, Punjab Province
About this study
Official title: 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.
Read the 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
- Conditions
- Low Back Pain
- Being tested
- core stabilization exercise, stabilization exercise
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core stabilization exerciseCombination 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
stabilization exerciseDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| core stabilization exercise | Experimental | Not described Receives: Combination Product: core stabilization exercise |
| stabilization exercise | Active comparator | Not described Receives: Diagnostic Test: stabilization exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start20 Mar 2025
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913413
- Sponsor's protocol ID
- MSRSW/Batch-Fall23/796
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of 8-Week Core Stabilization Exercise With Vitamin D On Pain and Functional Limitation in Adults With Chronic Non-Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT06913413
- Acronym / sponsor ID
- MSRSW/Batch-Fall23/796
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| core stabilization exercise | Experimental | Combination Product: core stabilization exercise |
| stabilization exercise | Active comparator | Diagnostic Test: stabilization exercise |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| core stabilization exerciseWill 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 | Combination product | core stabilization exercise |
| stabilization exercisestabilization 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 | Diagnostic test | stabilization exercise |
Primary outcome
The Visual Analogue Scale (VAS)
Time frame: 12 Months
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
The Oswestry Disability Index (ODI)
Time frame: 12 Months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing core stabilization exercise and stabilization exercise in people with Low Back Pain, run by Superior University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Visual Analogue Scale (VAS) (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.