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| ID | Type | Description | Link |
|---|---|---|---|
| Research Grant | Other Grant/Funding Number | University of Tabuk, Saudi Arabia |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physiotherapy Treatment | Experimental | 60 CLBP patients were randomized (30 per arm). Group A received physiotherapy only |
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| Physiotherapy and Vitamin D Supplementation | Experimental | 60 CLBP patients were randomized (30 per arm) Group B received physiotherapy and Vitamin D supplementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferential therapy | Device | Applied to lumbar region; standard protocol [specify frequency, intensity, duration per session] |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numerical pain rating scale | Patients assess their pain on an 11-point scale from 0-10 | 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 | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 weeks |
| Vitamin D Parameters |
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Inclusion Criteria:
Exclusion Criteria:
The study includes participants of both genders, aged 20 to 70 years.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tabuk | Tabuk | Tabuk Region | 71491 | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36045306 | Result | 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. | |
| 36527538 | Result | Mohamed 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. |
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The data will be shared based on the request
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| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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Physiotherapy: one group received interferential therapy and exercises, and the other group received physiotherapy and vitamin D supplementation prescribed by the physician
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| Interferential therapy | Device | 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 |
|
Low vitamin D levels are associated with increased pain severity, elevated disability scores, and poorer treatment outcomes in populations suffering from LBP
| 6 weeks |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |