Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain in Prediabetic Non-obese Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- HBA1C
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Not able to record data
- •previous spine surgeries
- •severe OA in knee
- •Spinal stenosis
- •Peripheral vascular diseases
- •Rheumatological diseases
- •Lumbar disc prolapse
- •uncooperative patient
研究组 & 干预措施
Interventional group
This group were assigned to 6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction.
干预措施: Ghazwan program (Dietary Supplement)
Control group
Ordinary painkillers given
干预措施: Standard management (Drug)
结局指标
主要结局
HBA1C
时间窗: 6 months
Diabetes index
次要结局
未报告次要终点
研究者
Hashim Talib Hashim
Doctor (MBChB)
University of Baghdad