Therapeutic Ultrasound on Renal Function

Low Back Pain Clinical Trial

Official title:

Effects of Therapeutic Ultrasound Applied to The Lumbar Region on Renal Function: A Randomised Controlled Prospective Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03746639
• Other study ID #: 2015-99-21/10
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: November 14, 2018

Study information

• Verified date: November 2018
• Source: Gaziosmanpasa Taksim Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 14, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Ultrasound Therapy; Complications

Intervention

Other:
• physiotherapy modalities
The physiotherapy modalities will be applied for five sessions a week for 3 weeks. The all patients will be treated with superficial heating (the moist heat pack will be applied to the patient's lower back for 20 minutes) , transcutaneous electrical nerve stimulation(frequency of 100 Hz, pulse duration of 100 µs, sensory-level amplitude was applied for 25 minutes) , exercise therapy (consisting of flexion, extension, stretching, mobilisation, and postural exercises performed for approximately 25 minutes ) . In addition to these therapies, continuous therapeutic ultrasound treatment will be applied to patients in first group for 10 minutes; frequency of 1 megahertz, intensity of 1.5 W/cm2, effective irradiation area of the transducer head 5 cm2 .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alper Mengi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of serum creatinine	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.	1 day
Primary	Value of 24-hour urine creatinine	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.	1 day
Primary	Value of creatinine clearance	Creatinine clearance will be calculated with the following formula: Urine creatinine (mg/dL) × urine volume (mL)/serum creatinine (mg/dL) × 1440.	1 day
Primary	glomerular filtration rate	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)	1 day
Primary	Concentration of serum cystatin C	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.	1 day
Primary	Value of 24-hour urine microalbumin	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.	1 day
Primary	Value of 24-hour urine microprotein	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.	1 day