Clinical trial NCT05753579: Is Regression Possible in Lumbal Disc Herniation With Spinal Mobilization Applications?
Official title: Is Regression Possible in Lumbal Disc Herniation Through Spinal Mobilization Applications? Double-Blind Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intervertebral Disc Displacement
Disk Herniated Lumbar
Disc Herniation
Keywords: Lumbar disc herniation
Manual Therapies
Mobilization
Stabilization Exercises
Lead sponsor: Muş Alparslan University
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was designed as a double-blind randomized controlled clinical trial. In order to carry out the prospectively designed study, ethics committee approval was obtained from the Non-Interventional Clinical Research Ethics Committee of Muş Alparslan University with the decision numbered 21 taken at the meeting dated 29.12.2020 and numbered 15. Informed consent was obtained from all patients included in the study before the study.
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: Disc herniation is the herniation of the nucleus pulposus, which is the disc material, into the spinal canal along the fibers of the annulus fibrosus. Spinal herniations that affect the whole spine are most common in the lumbar region, and most often in the L4-L5 and L5-S1 levels in this region. Lumbar disc herniation (LDH) is a common cause of low back pain, radicular pain, and radiculopathy, resulting in disability. Depending on the size of the herniation, the nerve is compressed in the lateral recess or in the foraminal or extraforaminal space. The pathophysiology of pain includes direct nerve root compression and local inflammation. Scientists have found that myelography is not as sensitive as magnetic resonance imaging (MRI) in diagnosing lumbar disc herniation, and MRI has a higher positivity rate. Compared with computed tomography, it has more imaging parameters, multiple tissue variable functions, more flexible and comprehensive, no radiation and no harm to the human body, and the diagnostic accuracy is better than CT scanning. Because of these advantages, MRI is the gold standard imaging method in the diagnosis of LDH. There are various treatment options available for LDH patients. These are basically divided into 2 categories: surgical and conservative care. Conservative care includes oral medications, corticosteroid and anesthetic infiltrations (nerve root injections), bed rest, exercise therapy, flexion/distraction therapy, manipulation and mobilization.Mobilization applications are passive movements that do not involve pushing or stimuli, applied within the range of motion or up to the physiological range of motion. Mobilization has mechanical effects such as increasing tissue flexibility, separating adhesions, relieving joint limitation and reducing intra-articular pressure. Evidence suggests that mobilizations cause a neurophysiological effect that results in sympathetic arousal, reduced neural mechanical sensitivity, mechanical hypoalgesia, and normalized muscle activity, endurance, and pain-free strength.There are many studies on the clinical use of mobilization methods. While most of these studies examine the effects of mobilization on pain and functional status in patients with low back pain, there are also studies examining the effects of mobilization on pain, functional status and activities of daily living in patients with LDH. In the literature, it has been determined that regression in the lumbar disc herniation distance is achieved with conservative treatment and medical treatment approaches. It is observed that there are studies examining the effect of manipulation on the herniation distance, which is one of the non-invasive Spinal Decompression Therapy method and Manual therapy methods. However, there is no study in the literature investigating the regression of spinal mobilization applications in LDH patients.The aim of our study is to examine the effects of spinal mobilization applications applied in three different planes in addition to stabilization exercises on radiological findings such as herniation distance, disc height and facet joint distance in LDH patients. Apart from radiological findings, it was also aimed to investigate the effects of patients on functional status, pain and flexibility.

Eligibility criteria: 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

Primary outcomes:
measure: Radiologic Assessment
timeFrame: 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 outcomes:
measure: Functional Assessment
timeFrame: 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.
measure: Pain Assessment
timeFrame: The change of pain assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment
measure: Range Of Motion Assesment
timeFrame: 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
measure: Flexibility Assessment
timeFrame: The change of flexibility assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment
Other outcomes:
Locations:
city: Muş
country: Turkey
facility: Muş Alparslan University
Study officials:
affiliation: Muş Alparslan University
name: Burhan Taşkaya
role: PRINCIPAL_INVESTIGATOR
References: