Therapeutic Ultrasound on Renal Function

NCT03746639 | Completed

• 1 other identifier: 2015-99-21/10
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Ultrasound Therapy; Complications; Low Back Pain

Keywords

Chronic Pain; physiotherapy; renal function

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

therapeutic ultrasound group

ACTIVE COMPARATOR

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

therapeutic ultrasound untreated group

OTHER

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

Interventions

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 .

therapeutic ultrasound group; therapeutic ultrasound untreated group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alper Mengi: lead

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Physiatrist

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 20, 2018
• Study Start: January 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: November 14, 2018
• Last Updated: November 27, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share