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Completed

NCT Number: NCT03746639

Therapeutic Ultrasound on Renal Function

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

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Key information

Conditions

Ultrasound Therapy; Complications Back Pain Chronic Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

physiotherapy modalities

Other

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 .

Primary outcomes

  1. Concentration of serum creatinine

    Time frame: 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.

  2. Value of 24-hour urine creatinine

    Time frame: 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.

  3. Value of creatinine clearance

    Time frame: 1 day

    Creatinine clearance will be calculated with the following formula:

    Urine creatinine (mg/dL) × urine volume (mL)/serum creatinine (mg/dL) × 1440.

  4. glomerular filtration rate

    Time frame: 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)

  5. Concentration of serum cystatin C

    Time frame: 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.

  6. Value of 24-hour urine microalbumin

    Time frame: 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.

  7. Value of 24-hour urine microprotein

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alper Mengi

Other Gov

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Nov 20, 2018
Registry last updated
Nov 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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