The Effect of a Lumbar Rotational Spinal Mobilization Technique With Lumbar Disc Herniation

Lumbar Disc Herniation Clinical Trial

Official title:

Acute Effect Of The Lumbar Rotational Spinal Mobilization Technique On Pain, Disability And Radiological Findings Of Patients With Lumbar Disc Herniation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05484791
• Other study ID #: 01/10/2019-E.13568
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: July 2022
• Source: Mus Alparlan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to research the effect of the Lumbar Spinal Rotational Mobilization technique on radiological findings, pain, disability and joint range of motion (ROM) in patients with lumbar disc herniation

Description:

In our study, it was aimed to investigate the acute effect of Lumbar Rotational Spinal Mobilization Technique on radiological findings, pain, disability and range of motion in 26 patients diagnosed with lumbar disc herniation(LDH) by magnetic resonance imaging(MRI) and physical examination. Disc height, herniation distance and facet joint distance of the patients were measured with MRI. Pain was assessed with the Visual Analogue Scale. Disability was measured with the Oswestry Low Back Pain Disability Questionnaire and Lumbar range of motion(ROM) was measured with a goniometer and tape measure. Rotational Spinal Mobilization Technique was applied to the patients in 2 sessions with a one-week interval, slowly and with 30 repetitions in both directions. All assessments were repeated within 1 week after treatment. It was observed whether there was an improvement in terms of radiological, pain, disability and ROM in the patients. 2 months after the 2nd evaluation, other parameters except the radiological evaluation were reapplied and it was tried to determine whether the effect persisted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

Inclusion Criteria:

• Being diagnosed with LDH by MRI and physical examination

• Having pain due to LDH

• Be between the ages of 18 and 65

Exclusion Criteria:

• History Of Spinal Surgery

• History Of Autoimmune Disease (Ankylosing Spondylitis, Rheumatoid Arthritis Or Other Disease)

• Spondylolysis Or Spondylolisthesis

• Spinal Fracture

• Cardiac Pathology

• Stroke History

• Cauda Equina Syndrome,

• Continuous Painkiller Drug Use

• Spinal inflammation

• Spinal Tumor

• Corticosteroid Drug Use In The Last Month

• Osteoporosis

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Lumbar Disc Herniation

Intervention

Other:
• The Lumbar Rotational Spinal Mobilization Technique
Patients included in the study underwent the lumbar rotational spinal mobilization(LRSM) technique during two sessions per week. The LRSM technique is applied while patients are lying on their side. The uppermost hip and knee are placed in 90 degree flexion, this is to assist rotational stress, and the lower leg is placed in extension. The lower shoulder is strongly pulled; thus, the upper shoulder is positioned toward the posterior and the pelvis moves anteriorly. The clinician stands in front of the patient. They stabilize the upper shoulder with one hand, and place the palm of the other hand behind the hard part of the ilium wing, with forearm horizontal and fingers turned toward the clinician. A rotational force is applied with pressure in the horizontal direction by pulling the hand on the ilium toward the clinician. In this position, 30 slow repeated movements are performed. The same practice is performed on both sides

Locations

Country	Name	City	State
Turkey	Mus Alparslan University	Mus

Sponsors (1)

Lead Sponsor	Collaborator
Mus Alparlan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of joint range of motion change	All patients participating in the study had lumbar flexion, lumbar extension, lumbar lateral flexion and lumbar rotations measured. Lumber flexion and lumbar lateral flexion were obtained by measuring the distance between the ground and middle finger tip with a tape measure. Lumber extension and lumbar rotations were measured with a goniometer	Joint range of motion was assessed and recorded 1 week before, 1 week and 2 months after treatment
Primary	Assessing disc height change	Images for radiological assessment of patients were obtained with a 1.5 Tesla GE brand Magnetic Resonance (MR) device. Sagittal T2A and axial T2A sequences were used. If the same person had herniation at different levels, the level with highest degree of herniation was included in the assessment. All MR images were obtained during the day between 16:00 and 18:00 hours	Disc height, was measured twice by a radiology expert 1 week before and 1 week after treatment
Primary	Assessing disc herniation thickness change	Images for radiological assessment of patients were obtained with a 1.5 Tesla GE brand Magnetic Resonance (MR) device. Sagittal T2A and axial T2A sequences were used. If the same person had herniation at different levels, the level with highest degree of herniation was included in the assessment. All MR images were obtained during the day between 16:00 and 18:00 hours	Disc herniation thickness was measured twice by a radiology expert 1 week before and 1 week after treatment
Primary	Assessing facet joint distance change	Images for radiological assessment of patients were obtained with a 1.5 Tesla GE brand Magnetic Resonance (MR) device. Sagittal T2A and axial T2A sequences were used. If the same person had herniation at different levels, the level with highest degree of herniation was included in the assessment. All MR images were obtained during the day between 16:00 and 18:00 hours	Facet joint distance was measured twice by a radiology expert 1 week before and 1 week after treatment
Secondary	Functional capacity change assessment	The Oswestry Low Back Pain Disability Questionnaire (OLBPDQ) was used to assess disability levels and quality of life linked to low back pain of patients. The OLBPDQ was developed to assess disability linked to pain for people with acute, subacute or chronic low back pain. The OLBPDQ contains 1 item related to pain and 9 items related to daily life activities (personal care, lifting, walking, sitting, standing, sleep, sexual life, social life and travel). Each item is rated on a 6-point scale ranked from the best scenario to the worst scenario. Points for each item increase by 1 for each response choice from 0 (first response choice) to 5 (final response choice). Missing values are skipped. Total points are calculated as a percentage value	The functional capacity of patients participating in the study was assessed 1 week before, 1 week and 2 months after treatment using the Oswestry Low Back Pain Disability Questionnaire.
Secondary	Pain change assessment	The pain levels felt by patients in their low back and surrounding regions was assessed with the visual analog scale (VAS). On this assessment, the patient expresses the pain levels felt by marking their position on a 10 cm scale numbered from 0 to 10 where 0 indicates no pain and 10 indicates unbearable pain. Cases are requested to express their pain by marking the appropriate number for their pain level on the scale and the value is recorded in cm.	Pain assessment was recorded 1 week before, 1 week and 2 months after treatment