Genetic AlterationLow back painNCT07439874
Genetic Alterations From Physical Therapy in Low Back Pain and Disc Degeneration
A study testing Interferential therapy in people with Genetic Alteration and Low Back Pain, run by University of Tabuk at 1 site in Saudi Arabia.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Genetic Alteration, Low Back Pain, Physiotherapy
- What is being tested?
- Interferential therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Aug 2024to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Skeletal deformities
- Rheumatologic conditions
- Progressive motor weakness
- Incontinence
- A history of cancer Use of systemic medications and illnesses Fractures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Genetic Alteration, Low Back Pain, Physiotherapy
- Being tested
- Interferential therapy
- Keywords
- Chronic low back pain, Physiotherapy, Vitamin D Supplementation, Interleukin-6
- Medical subject headings
- Congenital Abnormalities, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferential therapyDevice
Applied to lumbar region; standard protocol [specify frequency, intensity, duration per session]
Interferential therapyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy Treatment | Experimental | 60 CLBP patients were randomized (30 per arm). Group A received physiotherapy only Receives: Device: Interferential therapy |
| Physiotherapy and Vitamin D Supplementation | Experimental | 60 CLBP patients were randomized (30 per arm) Group B received physiotherapy and Vitamin D supplementation Receives: Device: Interferential therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical pain rating scale
Patients assess their pain on an 11-point scale from 0-10
Measured: 6 weeks
Arabic Oswestry Disability Scale
A self-assessment tool used to evaluate physical disability. It has been utilized specifically to measure disability related to back pain
Measured: 6 weeks
Secondary outcomes (2)
Inflammatory biomarkers-IL-6
IL-6 is a pro-inflammatory cytokine that is significantly elevated in individuals with CLBP, particularly in those with intervertebral disc degeneration
Measured: 6 weeks
Vitamin D Parameters
Low vitamin D levels are associated with increased pain severity, elevated disability scores, and poorer treatment outcomes in populations suffering from LBP
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start15 Aug 2024
- Primary completion25 Mar 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Genetic AlterationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Physiotherapy: one group received interferential therapy and exercises, and the other group received physiotherapy and vitamin D supplementation prescribed by the physician
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tabuk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahul Hameed Pakkir Mohamed, University of Tabuk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439874
- Sponsor's protocol ID
- UT-133-01-2021
- Other IDs
- Research Grant
- Acronym
- Low back pain
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be shared based on the request
Publications
Pakkir Mohamed SH, Al Amer HS, Nambi G. The effectiveness of Kinesio taping and conventional physical therapy in the management of chronic low back pain: a randomized clinical trial. Clin Rheumatol. 2023 Jan;42(1):233-244. doi: 10.1007/s10067-022-06352-3. Epub 2022 Sep 1.
PubMed 36045306Mohamed SHP, Alatawi SF. Effectiveness of Kinesio taping and conventional physical therapy in the management of knee osteoarthritis: a randomized clinical trial. Ir J Med Sci. 2023 Oct;192(5):2223-2233. doi: 10.1007/s11845-022-03247-9. Epub 2022 Dec 17.
PubMed 36527538
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Alterations Induced by the Physical Therapy Intervention in the Pathogenesis of Low Back Pain and Intervertebral Disc Degeneration of Tabuk Population, Saudi Arabia
- ClinicalTrials.gov ID
- NCT07439874
- Acronym / sponsor ID
- Low back pain / UT-133-01-2021
- Conditions
- Genetic Alteration, Low Back Pain, Physiotherapy
- Keywords
- Chronic low back pain, Physiotherapy, Vitamin D Supplementation, Interleukin-6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of TabukUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 27 Feb 2026 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Physiotherapy: one group received interferential therapy and exercises, and the other group received physiotherapy and vitamin D supplementation prescribed by the physician
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy Treatment | Experimental | Device: Interferential therapy60 CLBP patients were randomized (30 per arm). Group A received physiotherapy only |
| Physiotherapy and Vitamin D Supplementation | Experimental | Device: Interferential therapy60 CLBP patients were randomized (30 per arm) Group B received physiotherapy and Vitamin D supplementation |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- Skeletal deformities
- Rheumatologic conditions
- Progressive motor weakness
- Incontinence
- A history of cancer Use of systemic medications and illnesses Fractures.
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 |
|---|---|---|
| Interferential therapyApplied to lumbar region; standard protocol [specify frequency, intensity, duration per session] | Device | Physiotherapy Treatment |
| Interferential therapyApplied 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 | Device | Physiotherapy and Vitamin D Supplementation |
Primary outcome
Numerical pain rating scale
Time frame: 6 weeks
Patients assess their pain on an 11-point scale from 0-10
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
2 secondary outcomes
Inflammatory biomarkers-IL-6
Time frame: 6 weeks
Vitamin D Parameters
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Results publication: PubMed 36045306Pakkir Mohamed SH, Al Amer HS, Nambi G. The effectiveness of Kinesio taping and conventional physical therapy in the management of chronic low back pain: a randomized clinical trial. Clin Rheumatol. 2023 Jan;42(1):233-244. doi: 10.1007/s10067-022-06352-3. Epub 2022 Sep 1.
- Results publication: PubMed 36527538Mohamed SHP, Alatawi SF. Effectiveness of Kinesio taping and conventional physical therapy in the management of knee osteoarthritis: a randomized clinical trial. Ir J Med Sci. 2023 Oct;192(5):2223-2233. doi: 10.1007/s11845-022-03247-9. Epub 2022 Dec 17.
- Individual participant dataSharing planned: No. The data will be shared based on the request
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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 Interferential therapy in people with Genetic Alteration and Low Back Pain, run by University of Tabuk at 1 site in Saudi Arabia.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 3 Mar 2026. 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Numerical pain rating scale (time frame: 6 weeks). 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?
On the ClinicalTrials.gov record for NCT07439874, which also lists 2 linked publications.
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 3 Mar 2026.