Is Regression Possible in Lumbal Disc Herniation With Spinal Mobilization Applications?

NCT ID: NCT05753579

Last Updated: 2023-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-18
• Study Completion Date: 2022-07-25

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.

Conditions

Intervertebral Disc Displacement; Disk Herniated Lumbar; Disc Herniation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control Group

In our study, stabilization exercises were applied to the patients in the control group. The treatment was applied two days a week for five weeks, for a total of ten sessions. After the end of the treatment, stabilization exercises were recommended as a home exercise program until the follow-up evaluation at the third month. A telephone connection was established with the patients once a week and the home program was followed up.Stabilization exercises: It is an approach that is combined with diaphragmatic breathing and activates the passive. The stabilization exercise program was applied in three phases and was progressed in line with the developments in the patients.

Group Type: ACTIVE_COMPARATOR

Stabilization Exercise

Intervention Type: BEHAVIORAL

Diyafragmatik solunum ile kombine edilen, pasif-aktif kas iskelet sistemi ve nöral sistemi aktive eden bir yaklaşımdır. Bu yaklaşımda derin çekirdek kaslar olarak transversus abdominis, multifudus kasları aktive edilmektedir

Intervention Group

In our study, stabilization exercises and spinal mobilization practices were performed to the patients in the intervention group. The treatment was applied two days a week for five weeks, for a total of ten sessions. After the end of the treatment, stabilization exercises were recommended as a home exercise program until the follow-up evaluation at the third month. A telephone connection was established with the patients once a week and the home program was followed up.Mobilization applications were applied at Maitland IV degree as standard.Three mobilization methods were applied Anterior-Posterior Lumbal Spinal Mobilization Lumbal Spinal Rotational Mobilization Joint Mobilization in Lumbal Flexion Position

Group Type: EXPERIMENTAL

Spinal Mobilization

Intervention Type: BEHAVIORAL

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.

Stabilization Exercise

Intervention Type: BEHAVIORAL

Diyafragmatik solunum ile kombine edilen, pasif-aktif kas iskelet sistemi ve nöral sistemi aktive eden bir yaklaşımdır. Bu yaklaşımda derin çekirdek kaslar olarak transversus abdominis, multifudus kasları aktive edilmektedir

Interventions

Spinal 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.

Intervention Type: BEHAVIORAL

Stabilization Exercise

Diyafragmatik solunum ile kombine edilen, pasif-aktif kas iskelet sistemi ve nöral sistemi aktive eden bir yaklaşımdır. Bu yaklaşımda derin çekirdek kaslar olarak transversus abdominis, multifudus kasları aktive edilmektedir

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Muş Alparslan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Burhan Taşkaya

Role: PRINCIPAL_INVESTIGATOR

Muş Alparslan University

Locations

Muş Alparslan University

Muş, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-10879717-050.01.04

Identifier Type: -

Identifier Source: org_study_id