Therapeutic Ultrasound on Renal Function

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

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

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Ultrasound Therapy; Complications
• Intervention / Treatment: Other: physiotherapy modalities

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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 .
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.	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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Alper Mengi

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): November 14, 2018

Study Registration Dates

• First Submitted: November 14, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): November 27, 2018
• Last Update Submitted That Met QC Criteria: November 25, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Chronic Pain; physiotherapy; renal function
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2015-99-21/10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No