Intervertebral Disc Displacement Clinical Trial
Official title:
Is Regression Possible in Lumbal Disc Herniation Through Spinal Mobilization Applications? Double-Blind Randomized Controlled Clinical Trial
Verified date | March 2023 |
Source | Mus Alparlan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Spinal mobilization methods are passive maneuvers that are made lighter and do not exceed the physiological range of motion in order to increase joint mobility. Mobilization applications are easier and safer than manipulation applications involving forceful pushing. Although there are many literatures reporting the therapeutic efficacy of long-term mobilization applications on LDH, there is no study on the effect of applications on radiological findings of LDH. In the light of the information mentioned above, the aim of this study is; To examine the effect of mobilization applications on radiological findings and functional level in patients with LDH
Status | Completed |
Enrollment | 32 |
Est. completion date | July 25, 2022 |
Est. primary completion date | April 25, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria - It was determined as being diagnosed with LDH by MR by a physical therapy physician - Having pain of at least 3 levels or more according to the Visual Analogue Scale - Being between the ages of 18-65. Exclusion Criteria - History of spinal surgery - History of autoimmune disease (ankylosing spondylitis, rheumatoid arthritis or other) - Spondylolysis and spondylolisthesis - Spinal fracture - Heart pathology - History of stroke, - Cauda equina syndrome - Continuous use of pain medication - Spinal inflammation, - Spinal tumor - Covid - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Turkey | Mus Alparslan University | Mus |
Lead Sponsor | Collaborator |
---|---|
Mus Alparlan University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Radiologic Assessment | MRI examinations were performed before and after treatment in the same center. In both evaluations, the specialist radiologist did not know which group the patient was in. T2 and T1-weighted sagittal sections and T2-weighted axial sections were used as a basis for MRI evaluations. Disc height, hernia thickness and facet joint distance were evaluated in millimeters (mm). In case of herniation at different levels in the same person, the evaluation was performed on the level with the highest herniation degree. All MRI scans were done between 16 and 18 pm during the day. | The change of the disc height, herniation thickness and ZGAP (facet joint distance) were measured twice by a radiology expert before and after treatment | |
Secondary | Functional Assessment | Back Performance Scale (BPS): It is a scale used to detect performance that differs depending on low back pain. The scale consists of 5 questions and 4 options valued between 0-3 for each question. The result is obtained by summing the answers given to the questions. The higher the score, the lower the performance. | The change of functional capacity of patients participating in the study was assessed before treatment, through treatment completion, an average of 1 week and 3 months after treatment using the Oswestry Low Back Pain Disability Questionnaire. | |
Secondary | Pain Assessment | Visual Analog Scale (VAS): It is used to convert some values that cannot be measured numerically to digital. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line, and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing. For pain, I have no pain at one end and very severe pain at the other end and the patient marks his/her current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain. | The change of pain assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment | |
Secondary | Range Of Motion Assesment | Straight Leg Raise Test: In the evaluation of straight leg lift, the inclinometer was placed anterior to the tibia while the patient was lying on his back. The inclinometer was reset, the patient was asked to raise his leg and the value displayed on the inclinometer was recorded at the last point. | The change of range of motion assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment | |
Secondary | Flexibility Assessment | Sit and Reach Test: The person being tested was asked to come to a long sitting position with the knees straight and rest the soles of their feet flat on the bottom of the test board. The feet were positioned to be approximately shoulder-width apart, and the patient reached forward from the waist and hips with elbows, wrists and fingers tense. Care was taken to keep the knees straight during the test. The person being tested pushed forward the measuring board on the test bench with his fingers and waited for 1-2 seconds at the end point. The point where the feet made contact with the test bench was taken as the starting point, the 0 point. It was measured from the fingertip to the starting point and recorded in cm as '-' if it is in front of 0 point and '+' if it is behind. | The change of flexibility assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment |
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