- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05484791
The Effect of a Lumbar Rotational Spinal Mobilization Technique With Lumbar Disc Herniation
July 30, 2022 updated by: Muş Alparlan University
Acute Effect Of The Lumbar Rotational Spinal Mobilization Technique On Pain, Disability And Radiological Findings Of Patients With Lumbar Disc Herniation
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Muş, Turkey
- Muş Alparslan University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The Lumbar Rotational Spinal Mobilization Technique
Patients included in the study underwent the lumbar rotational spinal mobilization technique during two sessions per week
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessing disc height change
Time Frame: Disc height, was measured twice by a radiology expert 1 week before and 1 week after treatment
|
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
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Disc height, was measured twice by a radiology expert 1 week before and 1 week after treatment
|
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Assessing disc herniation thickness change
Time Frame: Disc herniation thickness was measured twice by a radiology expert 1 week before and 1 week after treatment
|
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
|
|
Assessing facet joint distance change
Time Frame: Facet joint distance was measured twice by a radiology expert 1 week before and 1 week after treatment
|
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional capacity change assessment
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.
|
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
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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.
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|
Pain change assessment
Time Frame: Pain assessment was recorded 1 week before, 1 week and 2 months after treatment
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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.
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Pain assessment was recorded 1 week before, 1 week and 2 months after treatment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of joint range of motion change
Time Frame: Joint range of motion was assessed and recorded 1 week before, 1 week and 2 months after treatment
|
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
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Joint range of motion was assessed and recorded 1 week before, 1 week and 2 months after treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: İsmail Taşkent, Mus State Hospital
- Study Chair: Mahmut Çakıllı, Mus State Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2019
Primary Completion (Actual)
April 1, 2020
Study Completion (Actual)
August 1, 2020
Study Registration Dates
First Submitted
July 19, 2022
First Submitted That Met QC Criteria
July 30, 2022
First Posted (Actual)
August 2, 2022
Study Record Updates
Last Update Posted (Actual)
August 2, 2022
Last Update Submitted That Met QC Criteria
July 30, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01/10/2019-E.13568
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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