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Therapeutic Ultrasound on Renal Function

Primary Purpose

Ultrasound Therapy; Complications, Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
physiotherapy modalities
Sponsored by
Alper Mengi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ultrasound Therapy; Complications focused on measuring Chronic Pain, physiotherapy, renal function

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    therapeutic ultrasound group

    therapeutic ultrasound untreated group

    Arm Description

    The patients will be treated with superficial heating, transcutaneous electrical nerve stimulation, exercise therapy and therapeutic ultrasound over the paravertebral low back region.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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)
    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 14, 2018
    Last Updated
    November 25, 2018
    Sponsor
    Alper Mengi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03746639
    Brief Title
    Therapeutic Ultrasound on Renal Function
    Official Title
    Effects of Therapeutic Ultrasound Applied to The Lumbar Region on Renal Function: A Randomised Controlled Prospective Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2016 (Actual)
    Primary Completion Date
    December 31, 2017 (Actual)
    Study Completion Date
    November 14, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Alper Mengi

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ultrasound Therapy; Complications, Low Back Pain
    Keywords
    Chronic Pain, physiotherapy, renal function

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    therapeutic ultrasound group
    Arm Type
    Active Comparator
    Arm Description
    The patients will be treated with superficial heating, transcutaneous electrical nerve stimulation, exercise therapy and therapeutic ultrasound over the paravertebral low back region.
    Arm Title
    therapeutic ultrasound untreated group
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    physiotherapy modalities
    Intervention Description
    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 Outcome Measure Information:
    Title
    Concentration of serum creatinine
    Description
    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.
    Time Frame
    1 day
    Title
    Value of 24-hour urine creatinine
    Description
    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.
    Time Frame
    1 day
    Title
    Value of creatinine clearance
    Description
    Creatinine clearance will be calculated with the following formula: Urine creatinine (mg/dL) × urine volume (mL)/serum creatinine (mg/dL) × 1440.
    Time Frame
    1 day
    Title
    glomerular filtration rate
    Description
    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)
    Time Frame
    1 day
    Title
    Concentration of serum cystatin C
    Description
    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.
    Time Frame
    1 day
    Title
    Value of 24-hour urine microalbumin
    Description
    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.
    Time Frame
    1 day
    Title
    Value of 24-hour urine microprotein
    Description
    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.
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Therapeutic Ultrasound on Renal Function

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