Lumbar Disc HerniationNCT05484791
The Effect of a Lumbar Rotational Spinal Mobilization Technique With Lumbar Disc Herniation
A study testing The Lumbar Rotational Spinal Mobilization Technique in people with Lumbar Disc Herniation, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
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 Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- The Lumbar Rotational Spinal Mobilization Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2019to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being diagnosed with LDH by MRI and physical examination
- Having pain due to LDH
- Be between the ages of 18 and 65
Who cannot join
- History Of Spinal Surgery
- History Of Autoimmune Disease (Ankylosing Spondylitis, Rheumatoid Arthritis Or Other Disease)
- Spondylolysis Or Spondylolisthesis
- Spinal Fracture
- Cardiac Pathology
- Stroke History
Show all 12Show fewer
- Cauda Equina Syndrome,
- Continuous Painkiller Drug Use
- Spinal inflammation
- Spinal Tumor
- Corticosteroid Drug Use İn The Last Month
- Osteoporosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Lumbar Disc Herniation
- Being tested
- The Lumbar Rotational Spinal Mobilization Technique
- Keywords
- Lumbar disc herniation, Manual therapy, Lumbar Spinal Rotational Mobilization
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Lumbar Rotational Spinal Mobilization TechniqueOther
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
| Study group | Role | What they receive |
|---|---|---|
| The Lumbar Rotational Spinal Mobilization Technique | Experimental | Patients included in the study underwent the lumbar rotational spinal mobilization technique during two sessions per week Receives: Other: The Lumbar Rotational Spinal Mobilization Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Disc height, was measured twice by a radiology expert 1 week before and 1 week after treatment
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
Measured: Disc herniation thickness was measured twice by a radiology expert 1 week before and 1 week after treatment
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
Measured: Facet joint distance was measured twice by a radiology expert 1 week before and 1 week after treatment
Secondary outcomes (2)
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
Measured: 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.
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.
Measured: Pain assessment was recorded 1 week before, 1 week and 2 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start1 Dec 2019
- Primary completion1 Apr 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- İsmail Taşkent, Study chair, Muş State HospitalMahmut Çakıllı, Study chair, Muş State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484791
- Sponsor's protocol ID
- 01/10/2019-E.13568
- Status last verified
- Jul 2022
- First submitted
- 19 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect Of The Lumbar Rotational Spinal Mobilization Technique On Pain, Disability And Radiological Findings Of Patients With Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT05484791
- Acronym / sponsor ID
- 01/10/2019-E.13568
- Conditions
- Lumbar Disc Herniation
- Keywords
- Lumbar disc herniation, Manual therapy, Lumbar Spinal Rotational Mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| The Lumbar Rotational Spinal Mobilization Technique | Experimental | Other: The Lumbar Rotational Spinal Mobilization TechniquePatients included in the study underwent the lumbar rotational spinal mobilization technique during two sessions per week |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being diagnosed with LDH by MRI and physical examination
- Having pain due to LDH
- Be between the ages of 18 and 65
Key exclusion criteria (12 listed)
- History Of Spinal Surgery
- History Of Autoimmune Disease (Ankylosing Spondylitis, Rheumatoid Arthritis Or Other Disease)
- Spondylolysis Or Spondylolisthesis
- Spinal Fracture
- Cardiac Pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Lumbar Rotational Spinal Mobilization TechniquePatients 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 | Other | The Lumbar Rotational Spinal Mobilization Technique |
Primary outcome
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
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
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
2 secondary outcomes
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.
Pain change assessment
Time frame: Pain assessment was recorded 1 week before, 1 week and 2 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İsmail Taşkent study chair
Muş State Hospital
Mahmut Çakıllı study chair
Muş State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Lumbar Rotational Spinal Mobilization Technique in people with Lumbar Disc Herniation, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing disc height change (time frame: Disc height, was measured twice by a radiology expert 1 week before and 1 week after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.