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

NCT05753579 | Completed

• 1 other identifier: E-10879717-050.01.04
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Intervertebral Disc Displacement; Disk Herniated Lumbar; Disc Herniation

Keywords

Lumbar disc herniation; Manual Therapies; Mobilization; Stabilization Exercises

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Functional Assessment

  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.

• Pain Assessment

  The change of pain assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment

• Range Of Motion Assesment

  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

• Flexibility Assessment

  The change of flexibility assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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.

Behavioral: Stabilization Exercise

Intervention Group

EXPERIMENTAL

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

Behavioral: Spinal Mobilization; Behavioral: Stabilization Exercise

Interventions

Spinal Mobilization 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.

Intervention Group

Stabilization Exercise 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

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Muş Alparslan University: lead

Study Sites (1)

Muş Alparslan University

Muş, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Burhan Taşkaya

  Muş Alparslan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Eligible patients were divided into two groups using the closed envelope method at a ratio of 1:1. The patients did not know which group they were in. This grouping was unknown to the radiologist performing the evaluation and the statistician performing the data analysis. Mobilization applications and other clinical tests were performed by the same physiotherapist in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 5, 2023
• First Posted: March 3, 2023
• Study Start: January 18, 2021
• Primary Completion: April 25, 2022
• Study Completion: July 25, 2022
• Last Updated: March 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)