Therapeutic Ultrasound on Renal Function

NCT ID: NCT03746639

Last Updated: 2018-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2018-11-14

Brief Summary

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

Detailed Description

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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.

Conditions

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Ultrasound Therapy; Complications Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

physiotherapy modalities

Intervention Type 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 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.

Group Type OTHER

physiotherapy modalities

Intervention Type 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 .

Interventions

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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 .

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alper Mengi

OTHER_GOV

Sponsor Role lead

Responsible Party

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Alper Mengi

M.D., Physiatrist

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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2015-99-21/10

Identifier Type: -

Identifier Source: org_study_id

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