Study Results
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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COMPLETED
NA
40 participants
INTERVENTIONAL
2016-01-01
2018-11-14
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
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.
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 .
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.
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 .
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 .
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Alper Mengi
OTHER_GOV
Responsible Party
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Alper Mengi
M.D., Physiatrist
Other Identifiers
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2015-99-21/10
Identifier Type: -
Identifier Source: org_study_id
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