Therapeutic Ultrasound on Renal Function

Not Applicable

Completed

• Conditions: Ultrasound Therapy; Complications; Low Back Pain
• Interventions: Other: physiotherapy modalities

• Registration Number: NCT03746639
• Lead Sponsor: Alper Mengi

Brief Summary

This study evaluates whether therapeutic ultrasound (TUS) treatment applied to lumbar region with chronic low back pain affect renal function.

Detailed Description

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.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2017-12-31
• Status Verified: 2018-11
• Study Completion: 2018-11-14
• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-15
• Study First Posted: 2018-11-20
• Last Update Submitted: 2018-11-25
• Last Update Posted: 2018-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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 .

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
therapeutic ultrasound group	physiotherapy modalities	The patients will be treated with superficial heating, transcutaneous electrical nerve stimulation, exercise therapy and therapeutic ultrasound over the paravertebral low back region.
therapeutic ultrasound untreated group	physiotherapy modalities	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.

Primary Outcome Measures

Name	Time	Method
Concentration of serum creatinine	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	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	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	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	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	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	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.