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

Primary Purpose

Lumbar Disc Herniation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The Lumbar Rotational Spinal Mobilization Technique
Sponsored by
Muş Alparlan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring Lumbar disc herniation, Manual therapy, Lumbar Spinal Rotational Mobilization

Eligibility Criteria

19 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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 İn The Last Month
  • Osteoporosis

Sites / Locations

  • Muş Alparslan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The Lumbar Rotational Spinal Mobilization Technique

Arm Description

Patients included in the study underwent the lumbar rotational spinal mobilization technique during two sessions per week

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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
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.

Full Information

First Posted
July 19, 2022
Last Updated
July 30, 2022
Sponsor
Muş Alparlan University
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1. Study Identification

Unique Protocol Identification Number
NCT05484791
Brief Title
The Effect of a Lumbar Rotational Spinal Mobilization Technique With Lumbar Disc Herniation
Official Title
Acute Effect Of The Lumbar Rotational Spinal Mobilization Technique On Pain, Disability And Radiological Findings Of Patients With Lumbar Disc Herniation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Muş Alparlan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
Keywords
Lumbar disc herniation, Manual therapy, Lumbar Spinal Rotational Mobilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The research was designed as a semi-experimental study with pre-test (before implementation), post-test (after implementation) and 2-month follow-up assessments
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The Lumbar Rotational Spinal Mobilization Technique
Arm Type
Experimental
Arm Description
Patients included in the study underwent the lumbar rotational spinal mobilization technique during two sessions per week
Intervention Type
Other
Intervention Name(s)
The Lumbar Rotational Spinal Mobilization Technique
Intervention Description
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
Primary Outcome Measure Information:
Title
Assessing disc height change
Description
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
Time Frame
Disc height, was measured twice by a radiology expert 1 week before and 1 week after treatment
Title
Assessing disc herniation thickness change
Description
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
Time Frame
Disc herniation thickness was measured twice by a radiology expert 1 week before and 1 week after treatment
Title
Assessing facet joint distance change
Description
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
Time Frame
Facet joint distance was measured twice by a radiology expert 1 week before and 1 week after treatment
Secondary Outcome Measure Information:
Title
Functional capacity change assessment
Description
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
Time Frame
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.
Title
Pain change assessment
Description
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.
Time Frame
Pain assessment was recorded 1 week before, 1 week and 2 months after treatment
Other Pre-specified Outcome Measures:
Title
Evaluation of joint range of motion change
Description
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
Time Frame
Joint range of motion was assessed and recorded 1 week before, 1 week and 2 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 İn The Last Month Osteoporosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İsmail Taşkent
Organizational Affiliation
Muş State Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mahmut Çakıllı
Organizational Affiliation
Muş State Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Muş Alparslan University
City
Muş
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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