Intervertebral Disc DisplacementNCT05753579
Is Regression Possible in Lumbal Disc Herniation With Spinal Mobilization Applications?
A study testing Spinal Mobilization and Stabilization Exercise in people with Intervertebral Disc Displacement and Disk Herniated Lumbar, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intervertebral Disc Displacement, Disk Herniated Lumbar, Disc Herniation
- What is being tested?
- Spinal Mobilization and Stabilization Exercise
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2021to 25 Jul 2022
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of spinal surgery
- History of autoimmune disease (ankylosing spondylitis, rheumatoid arthritis or other)
- Spondylolysis and spondylolisthesis
- Spinal fracture
- Heart pathology
- History of stroke,
Show all 12Show fewer
- Cauda equina syndrome
- Continuous use of pain medication
- Spinal inflammation,
- Spinal tumor
- Covid
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Regression Possible in Lumbal Disc Herniation Through Spinal Mobilization Applications? Double-Blind Randomized Controlled Clinical Trial
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
Read the detailed description
Disc herniation is the herniation of the nucleus pulposus, which is the disc material, into the spinal canal along the fibers of the annulus fibrosus. Spinal herniations that affect the whole spine are most common in the lumbar region, and most often in the L4-L5 and L5-S1 levels in this region. Lumbar disc herniation (LDH) is a common cause of low back pain, radicular pain, and radiculopathy, resulting in disability. Depending on the size of the herniation, the nerve is compressed in the lateral recess or in the foraminal or extraforaminal space. The pathophysiology of pain includes direct nerve root compression and local inflammation. Scientists have found that myelography is not as sensitive as magnetic resonance imaging (MRI) in diagnosing lumbar disc herniation, and MRI has a higher positivity rate. Compared with computed tomography, it has more imaging parameters, multiple tissue variable functions, more flexible and comprehensive, no radiation and no harm to the human body, and the diagnostic accuracy is better than CT scanning. Because of these advantages, MRI is the gold standard imaging method in the diagnosis of LDH. There are various treatment options available for LDH patients. These are basically divided into 2 categories: surgical and conservative care. Conservative care includes oral medications, corticosteroid and anesthetic infiltrations (nerve root injections), bed rest, exercise therapy, flexion/distraction therapy, manipulation and mobilization.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. Mobilization has mechanical effects such as increasing tissue flexibility, separating adhesions, relieving joint limitation and reducing intra-articular pressure. Evidence suggests that mobilizations cause a neurophysiological effect that results in sympathetic arousal, reduced neural mechanical sensitivity, mechanical hypoalgesia, and normalized muscle activity, endurance, and pain-free strength.There are many studies on the clinical use of mobilization methods. While most of these studies examine the effects of mobilization on pain and functional status in patients with low back pain, there are also studies examining the effects of mobilization on pain, functional status and activities of daily living in patients with LDH. In the literature, it has been determined that regression in the lumbar disc herniation distance is achieved with conservative treatment and medical treatment approaches. It is observed that there are studies examining the effect of manipulation on the herniation distance, which is one of the non-invasive Spinal Decompression Therapy method and Manual therapy methods. However, there is no study in the literature investigating the regression of spinal mobilization applications in LDH patients.The aim of our study is to examine the effects of spinal mobilization applications applied in three different planes in addition to stabilization exercises on radiological findings such as herniation distance, disc height and facet joint distance in LDH patients. Apart from radiological findings, it was also aimed to investigate the effects of patients on functional status, pain and flexibility.
- Being tested
- Spinal Mobilization, Stabilization Exercise
- Keywords
- Lumbar disc herniation, Manual Therapies, Mobilization, Stabilization Exercises
- 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.
Spinal MobilizationBehavioural
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.
Stabilization ExerciseBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Spinal Mobilization; Behavioral: Stabilization Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Back Performance Scale (BPS): It is a scale used to detect performance that differs depending on low back pain. The scale consists of 5 questions and 4 options valued between 0-3 for each question. The result is obtained by summing the answers given to the questions. The higher the score, the lower the performance.
Measured: 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
Visual Analog Scale (VAS): It is used to convert some values that cannot be measured numerically to digital. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line, and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing. For pain, I have no pain at one end and very severe pain at the other end and the patient marks his/her current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain.
Measured: 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
Straight Leg Raise Test: In the evaluation of straight leg lift, the inclinometer was placed anterior to the tibia while the patient was lying on his back. The inclinometer was reset, the patient was asked to raise his leg and the value displayed on the inclinometer was recorded at the last point.
Measured: 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
Sit and Reach Test: The person being tested was asked to come to a long sitting position with the knees straight and rest the soles of their feet flat on the bottom of the test board. The feet were positioned to be approximately shoulder-width apart, and the patient reached forward from the waist and hips with elbows, wrists and fingers tense. Care was taken to keep the knees straight during the test. The person being tested pushed forward the measuring board on the test bench with his fingers and waited for 1-2 seconds at the end point. The point where the feet made contact with the test bench was taken as the starting point, the 0 point. It was measured from the fingertip to the starting point and recorded in cm as '-' if it is in front of 0 point and '+' if it is behind.
Measured: The change of flexibility assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 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 posted3 Mar 2023
- Study start18 Jan 2021
- Primary completion25 Apr 2022
- Study completion25 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc DisplacementStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Burhan Taşkaya, Principal investigator, Muş Alparslan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753579
- Sponsor's protocol ID
- E-10879717-050.01.04
- Status last verified
- Mar 2023
- First submitted
- 5 Feb 2023
- Last updated
- 3 Mar 2023
- 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 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Regression Possible in Lumbal Disc Herniation Through Spinal Mobilization Applications? Double-Blind Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05753579
- Acronym / sponsor ID
- E-10879717-050.01.04
- Keywords
- Lumbar disc herniation, Manual Therapies, Mobilization, Stabilization Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 3 Mar 2023 (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.
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
Detailed description
Disc herniation is the herniation of the nucleus pulposus, which is the disc material, into the spinal canal along the fibers of the annulus fibrosus. Spinal herniations that affect the whole spine are most common in the lumbar region, and most often in the L4-L5 and L5-S1 levels in this region. Lumbar disc herniation (LDH) is a common cause of low back pain, radicular pain, and radiculopathy, resulting in disability. Depending on the size of the herniation, the nerve is compressed in the lateral recess or in the foraminal or extraforaminal space. The pathophysiology of pain includes direct nerve root compression and local inflammation. Scientists have found that myelography is not as sensitive as magnetic resonance imaging (MRI) in diagnosing lumbar disc herniation, and MRI has a higher positivity rate. Compared with computed tomography, it has more imaging parameters, multiple tissue variable functions, more flexible and comprehensive, no radiation and no harm to the human body, and the diagnostic accuracy is better than CT scanning. Because of these advantages, MRI is the gold standard imaging method in the diagnosis of LDH. There are various treatment options available for LDH patients. These are basically divided into 2 categories: surgical and conservative care. Conservative care includes oral medications, corticosteroid and anesthetic infiltrations (nerve root injections), bed rest, exercise therapy, flexion/distraction therapy, manipulation and mobilization.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. Mobilization has mechanical effects such as increasing tissue flexibility, separating adhesions, relieving joint limitation and reducing intra-articular pressure. Evidence suggests that mobilizations cause a neurophysiological effect that results in sympathetic arousal, reduced neural mechanical sensitivity, mechanical hypoalgesia, and normalized muscle activity, endurance, and pain-free strength.There are many studies on the clinical use of mobilization methods. While most of these studies examine the effects of mobilization on pain and functional status in patients with low back pain, there are also studies examining the effects of mobilization on pain, functional status and activities of daily living in patients with LDH. In the literature, it has been determined that regression in the lumbar disc herniation distance is achieved with conservative treatment and medical treatment approaches. It is observed that there are studies examining the effect of manipulation on the herniation distance, which is one of the non-invasive Spinal Decompression Therapy method and Manual therapy methods. However, there is no study in the literature investigating the regression of spinal mobilization applications in LDH patients.The aim of our study is to examine the effects of spinal mobilization applications applied in three different planes in addition to stabilization exercises on radiological findings such as herniation distance, disc height and facet joint distance in LDH patients. Apart from radiological findings, it was also aimed to investigate the effects of patients on functional status, pain and flexibility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Stabilization ExerciseIn 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. |
| Intervention Group | Experimental | Behavioral: Spinal Mobilization, Behavioral: Stabilization ExerciseIn 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- History of spinal surgery
- History of autoimmune disease (ankylosing spondylitis, rheumatoid arthritis or other)
- Spondylolysis and spondylolisthesis
- Spinal fracture
- Heart 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 |
|---|---|---|
| Spinal MobilizationMobilization 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. | Behavioural | Intervention Group |
| Stabilization ExerciseDiyafragmatik 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 | Behavioural | Control Group, Intervention Group |
Primary outcome
Radiologic Assessment
Time frame: The change of the disc height, herniation thickness and ZGAP (facet joint distance) were measured twice by a radiology expert before and after treatment
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.
4 secondary outcomes
Functional Assessment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: The change of flexibility assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 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 3 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Intervertebral Disc Displacement
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Lumbar Disc Herniation
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Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
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Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation
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Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
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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.
Burhan Taşkaya principal investigator
Muş Alparslan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Mobilization and Stabilization Exercise in people with Intervertebral Disc Displacement and Disk Herniated Lumbar, 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 3 Mar 2023. 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?
Radiologic Assessment (time frame: The change of the disc height, herniation thickness and ZGAP (facet joint distance) were measured twice by a radiology expert before and after treatment). 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 3 Mar 2023.