Effects of Therapeutic Ultrasound Applied to The Lumbar Region on Renal Function: A Randomised Controlled Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Concentration of serum creatinine
研究概览
简要总结
This study evaluates whether therapeutic ultrasound (TUS) treatment applied to lumbar region with chronic low back pain affect renal function.
详细描述
Low back pain is a common problem and there are many treatments for chronic low back pain, including TUS. Investigators routinely observed increased blood creatinine and urea levels in some of patients who received TUS.
Half of patients will receive TUS treatment for low back pain while the other half will not receive. The patients will be evaluated at baseline and the end of the treatment . The serum creatinine, serum cystatin C, 24-hour urine creatinine, creatinine clearance, 24-hour urine microalbumin and microprotein, urine volume, and GFR will be measured at each evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged between 18 and 65 years
- •with chronic mechanical low back pain for at least 3 months
- •with glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m2, as calculated using the Modification of Diet in Renal Disease formula .
排除标准
- •history of lumbar surgery
- •having inflammatory low back pain
- •having pregnancy
- •having active infection
- •history of malignancy
- •having coagulation disorder
- •having a cardiac pacemaker
- •having heart failure
- •having uncontrolled hypertension or hypotension
- •having active psychiatric disease
- •presence of skin diseases on low back pain
- •taking medicines for low back pain during the physical therapy treatment (except for paracetamol)
- •taking a new drug for another disease or undergoing a dose change for a drug taken during the course of physiotherapy.
研究组 & 干预措施
therapeutic ultrasound group
The patients will be treated with superficial heating, transcutaneous electrical nerve stimulation, exercise therapy and therapeutic ultrasound over the paravertebral low back region.
干预措施: physiotherapy modalities (Other)
therapeutic ultrasound untreated group
The patients will be treated with superficial heating, transcutaneous electrical nerve stimulation, exercise therapy over the paravertebral low back region.Therapeutic ultrasound will not be applied to this group.
干预措施: physiotherapy modalities (Other)
结局指标
主要结局
Concentration of serum creatinine
时间窗: 1 day
To measure the serum creatinine levels, 5 mL of venous blood will be collected in a tube containing a gel separator and clot activator in the morning after a 12-hour fast. Serum creatinine will be measured in an autoanalyser.
Value of 24-hour urine creatinine
时间窗: 1 day
After the first urine sample of the first day was discarded, 24-hour urine samples will be collected, including the first of the next day. The 24-hour urine samples will be analysed on the day of collection, and will be analysed using colorimetric method in an autoanalyser.
Value of creatinine clearance
时间窗: 1 day
Creatinine clearance will be calculated with the following formula: Urine creatinine (mg/dL) × urine volume (mL)/serum creatinine (mg/dL) × 1440.
glomerular filtration rate
时间窗: 1 day
Glomerular filtration rate will be as calculated using the Modification of Diet in Renal Disease formula. (GFR (mL/min/1.73 m²) = 175 × (Scr)-1.154 × (Age)-0.203 × (0.742 if female) × (1.212 if African American)
Concentration of serum cystatin C
时间窗: 1 day
To measure the cystatin-C levels, 5 mL of venous blood will be collected in a tube containing a gel separator and clot activator in the morning after a 12-hour fast. Serum cystatin C will be determined using a sandwich enzyme immunoassay kit.
Value of 24-hour urine microalbumin
时间窗: 1 day
After the first urine sample of the first day was discarded, 24-hour urine samples will be collected, including the first of the next day. The 24-hour urine samples will be analysed on the day of collection, and will be analysed using immunoturbidimetric method in an autoanalyser.
Value of 24-hour urine microprotein
时间窗: 1 day
After the first urine sample of the first day was discarded, 24-hour urine samples will be collected, including the first of the next day. The 24-hour urine samples will be analysed on the day of collection, and will be analysed using colorimetric method in an autoanalyser.
次要结局
未报告次要终点
研究者
Alper Mengi
M.D., Physiatrist
Gaziosmanpasa Research and Education Hospital