Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain

Study Overview
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Brief Summary
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Prediabetes, characterized by elevated HbA1c levels, is a common precursor to type 2 diabetes mellitus. Recent studies have suggested a potential link between prediabetes and nonspecific back pain. This randomized controlled trial aimed to assess whether reducing HbA1c levels through lifestyle interventions and, along with the correction of vitamin D and magnesium, can alleviate nonspecific back pain in prediabetic patients.

Detailed Description
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The study included 40 patients from an outpatient clinic in Baghdad, evenly divided into intervention and control groups. The intervention group underwent a 6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction. HbA1c levels were measured, and back pain severity was assessed (through what assessment method ?). The control group received standard care with NSAIDs and acetaminophen for pain management. Assessments were conducted at baseline and at various intervals over a total period of 6 months to evaluate changes in HbA1c levels and back pain intensity. This randomized controlled trial provides evidence that reducing HbA1c levels through lifestyle modifications, along with the correction of vitamin D and magnesium, can lead to a reduction in nonspecific back pain intensity and improved functional outcomes in prediabetic patients.

Official Title
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Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain in Prediabetic Non-obese Patients: A Randomized Controlled Trial

Conditions
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Back Pain Lower Back Chronic, Back Pain, Pre Diabetes, Diabetes, Back Pain, Low

Intervention / Treatment
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* Dietary Supplement: Ghazwan program
* Drug: Standard management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Poor sleep (less than 6 hours per day) chronic back pain Multiple joint pain non-specific back pain HBA1C more than 5.7 ability to record the data Exclusion Criteria: Not able to record data previous spine surgeries severe OA in knee Spinal stenosis Peripheral vascular diseases Rheumatological diseases Lumbar disc prolapse uncooperative patient

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three Groups: Case Palcebo No placebo, no intervention group
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional group<br>This group were assigned to 6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction. | Dietary Supplement: Ghazwan program<br>* 6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction.<br>|
| Placebo Comparator: Control group<br>Ordinary painkillers given | Drug: Standard management<br>* Standard care with NSAIDs and acetaminophen for pain management<br>|
| No Intervention: No Placebo, no intervention group<br>Nothing was given to them neither 6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction nor painkillers. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBA1C | Diabetes index | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Back Pain, HBA1C