Disc Prolapse With RadiculopathyNCT06359470
the Modified Reversed Contralateral Axial Rotation Position
A study testing Positioning technique in people with Disc Prolapse With Radiculopathy, run by Noha Khaled Shoukry at 1 site in Egypt.
Trial summary
This study aimed to investigate the effect of specific three-dimensional (3D) positions of the trunk on patients with lumbar discogenic pain with radiculopathy aiming to find a position that directly decompresses the impinged root as well as the effect of this position on the CSA of the L3-L4, L4-L5 and L5-S1… Read more about this study
- Who is it for?
- Ages 20 to 40 years, men only
- Conditions the study is for
- Disc Prolapse With Radiculopathy
- What is being tested?
- Positioning technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Nov 2022to 14 Jan 2024
- 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 20 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- All patients had a second-grade disc bulge (2-3mm) which was detected from the T2 axial view of MRI. All patients had radiculopathy due to lumbar disc prolapse. The diagnosis was confirmed by physical, neurological examination (motor assessment, sensory assessment, reflexes), and radiological assessment (CT or MRI)
Who cannot join
- bilateral and multilevel disc prolapse, sequestrated , migrated and disc herniation defined by MRI , acute onset of pain (pain less than three months), presence of active infection in the lumbar spine, any spinal deformities e.g., moderate, or severe scoliosis deformity (Cobb angle ≥ 25°), postoperative cases, Cauda equine lesion, the presence of any comorbidities, history of patients who suffered from cancer, unexplained weight loss, immunosuppression, prolonged use of steroids, intravenous drug use, urinary tract infection, pain that is increased or unrelieved by rest, fever, significant trauma related to age, bladder or bowel incontinence, urinary retention (with overflow incontinence), saddle anesthesia, loss of anal sphincter tone, major motor weakness in lower extremities, fever, and vertebral tenderness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3D CT Scan of the Modified Reversed Contralateral Axial Rotation Position in Patients With Lumbar Disc Prolapse. A New Manual Nerve Decompression Position.
This study aimed to investigate the effect of specific three-dimensional (3D) positions of the trunk on patients with lumbar discogenic pain with radiculopathy aiming to find a position that directly decompresses the impinged root as well as the effect of this position on the CSA of the L3-L4, L4-L5 and L5-S1 intervertebral foramen (IVF) using 3D-CT scan imaging of the real spine
Read the detailed description
Background: Management of lumbar discogenic pain is complex and there is ongoing debate over both surgical and conventional conservative treatments. Purpose: This study aimed to investigate the real-time effect of specific three-dimensional (3D) positions of the trunk on patients with lumbar discogenic pain with radiculopathy aiming to find a position that directly decompresses the impinged root as well as the effect of this position on the CSA of the L3-L4, L4-L5 and L5-S1 intervertebral foramen (IVF) using 3D-CT scan imaging of the real spine. Methods: This study was conducted on ninety male patients (30 in each group), ages ranged from 20 - 40 years old, and were diagnosed with unilateral lumbar disc prolapse (group1: L3-L4), (group 2: L4- L5) and (group 3: L5-S1) for at least three months in a radiology center specialized in the spine (Egyscan center). Each group was imaged three times (from the supine position, then from the oblique position after 10 minutes, and finally from the oblique position again after 48 hours). The oblique image was taken during a specific trunk position the modified reversed contralateral rotation (side-lying on a hard pillow with side bending to the non-affected side and rotation to non affected side).The CSA of LIVF and SLR test were assessed at the three times of testing Results: The mixed design MANOVA revealed that the mean values of the LIVF CSA and the SLR significantly increased in the reversed contralateral rotation position after 48 hours compared to the same position after 10 minutes and the supine position in the three tested groups (P=0.001). Moreover, the LIVF CSA and the SLR significantly increased in the reversed contralateral rotation position after 10 minutes compared to the supine position in the three tested groups (P=0.001). Conclusion: Modified reversed contralateral rotation of the trunk has a real-time decompressing effect on patients with lumbar disc prolapse as well as a significantly increasing effect on the CSA of L3-L4, L4-L5 and L5-S1 IVF in the three tested groups. Changing the spine position from supine to the modified reversed contralateral rotation position had a great clinical value on patients with lumbar discogenic pain with radiculopathy.
- Conditions
- Disc Prolapse With Radiculopathy
- Being tested
- Positioning technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positioning techniqueOther
First time of testing: Firstly, the patients were scanned in the conventional neutral supine position and a 3D-CT scan was taken.
Second time of testing: after 10 minutes, the patients were scanned in the modified reversed contralateral rotation (side-lying on a hard pillow with side bending to the non-affected side and rotation to non affected side). This is achieved through instructing the participant to first lie on the side lying on a wedge pillow (that is flexible with dimensions of 30 cm in height and 75 cm in length) to achieve trunk side bending to non-affected side this pillow is the same for all patients, then the patient/participant rotated to the affected side (pelvis on the trunk rotation), and 3D-CT scan.
Third time of testing: after 48 hours, the patients were scanned in the modified reversed contralateral rotation.
| Study group | Role | What they receive |
|---|---|---|
| positioning | Experimental | the supine position, then from the oblique position after 10 minutes, and finally from the oblique position again after 48 hours Receives: Other: Positioning technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Straight leg raising test
With the patient in the supine position and the hips were neutral, neither abducted nor adducted nor rotated, the investigator lifted the leg slowly while the knee was kept in extended position. Each leg is raised separately until pain occurs. When the patient reported feeling radiating pain the angle between the bed and the leg was recorded by a goniometer
Measured: 48 hours
Secondary outcomes (1)
Foraminal cross sectional area
The foraminal area was defined as the outline of the LIVF. It is measured by the boundary of the adjacent superior and inferior vertebral pedicles, the posterosuperior portion of the inferior vertebral body, the posterior portion of the intervertebral disc, the posteroinferior portion of the superior vertebral body, and the anterior portion of ligamentum flavum
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start5 Nov 2022
- Primary completion1 Oct 2023
- Study completion14 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disc Prolapse With RadiculopathyStudies 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
- Sequential
- Model description
- This study was conducted on ninety male patients (30 in each group), ages ranged from 20 - 40 years old, and were diagnosed with unilateral lumbar disc prolapse (group1: L3-L4), (group 2: L4- L5) and (group 3: L5-S1) for at least three months in a radiology center specialized in the spine (Egyscan center). Each group was imaged three times (from the supine position, then from the oblique position after 10 minutes, and finally from the oblique position again after 48 hours). The oblique image was taken during a specific trunk position the modified reversed contralateral rotation (side-lying with side bending to the non-affected side and rotation to non affected side).The CSA of LIVF and SLR test was assessed at the three times of testing
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noha Khaled Shoukry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Noha Khaled Shoukry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359470
- Sponsor's protocol ID
- CaiUni
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 11 Apr 2024
- 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 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D CT Scan of the Modified Reversed Contralateral Axial Rotation Position in Patients With Lumbar Disc Prolapse. A New Manual Nerve Decompression Position.
- ClinicalTrials.gov ID
- NCT06359470
- Acronym / sponsor ID
- CaiUni
- Conditions
- Disc Prolapse With Radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Noha Khaled ShoukryUniversity, hospital or other
- Study start
- 5 Nov 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 14 Jan 2024 (actual)
- First posted
- 11 Apr 2024 (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.
This study aimed to investigate the effect of specific three-dimensional (3D) positions of the trunk on patients with lumbar discogenic pain with radiculopathy aiming to find a position that directly decompresses the impinged root as well as the effect of this position on the CSA of the L3-L4, L4-L5 and L5-S1 intervertebral foramen (IVF) using 3D-CT scan imaging of the real spine
Detailed description
Background: Management of lumbar discogenic pain is complex and there is ongoing debate over both surgical and conventional conservative treatments. Purpose: This study aimed to investigate the real-time effect of specific three-dimensional (3D) positions of the trunk on patients with lumbar discogenic pain with radiculopathy aiming to find a position that directly decompresses the impinged root as well as the effect of this position on the CSA of the L3-L4, L4-L5 and L5-S1 intervertebral foramen (IVF) using 3D-CT scan imaging of the real spine. Methods: This study was conducted on ninety male patients (30 in each group), ages ranged from 20 - 40 years old, and were diagnosed with unilateral lumbar disc prolapse (group1: L3-L4), (group 2: L4- L5) and (group 3: L5-S1) for at least three months in a radiology center specialized in the spine (Egyscan center). Each group was imaged three times (from the supine position, then from the oblique position after 10 minutes, and finally from the oblique position again after 48 hours). The oblique image was taken during a specific trunk position the modified reversed contralateral rotation (side-lying on a hard pillow with side bending to the non-affected side and rotation to non affected side).The CSA of LIVF and SLR test were assessed at the three times of testing Results: The mixed design MANOVA revealed that the mean values of the LIVF CSA and the SLR significantly increased in the reversed contralateral rotation position after 48 hours compared to the same position after 10 minutes and the supine position in the three tested groups (P=0.001). Moreover, the LIVF CSA and the SLR significantly increased in the reversed contralateral rotation position after 10 minutes compared to the supine position in the three tested groups (P=0.001). Conclusion: Modified reversed contralateral rotation of the trunk has a real-time decompressing effect on patients with lumbar disc prolapse as well as a significantly increasing effect on the CSA of L3-L4, L4-L5 and L5-S1 IVF in the three tested groups. Changing the spine position from supine to the modified reversed contralateral rotation position had a great clinical value on patients with lumbar discogenic pain with radiculopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study was conducted on ninety male patients (30 in each group), ages ranged from 20 - 40 years old, and were diagnosed with unilateral lumbar disc prolapse (group1: L3-L4), (group 2: L4- L5) and (group 3: L5-S1) for at least three months in a radiology center specialized in the spine (Egyscan center). Each group was imaged three times (from the supine position, then from the oblique position after 10 minutes, and finally from the oblique position again after 48 hours). The oblique image was taken during a specific trunk position the modified reversed contralateral rotation (side-lying with side bending to the non-affected side and rotation to non affected side).The CSA of LIVF and SLR test was assessed at the three times of testing
| Arm | Type | Receives |
|---|---|---|
| positioning | Experimental | Other: Positioning techniquethe supine position, then from the oblique position after 10 minutes, and finally from the oblique position again after 48 hours |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All patients had a second-grade disc bulge (2-3mm) which was detected from the T2 axial view of MRI. All patients had radiculopathy due to lumbar disc prolapse. The diagnosis was confirmed by physical, neurological examination (motor assessment, sensory assessment, reflexes), and radiological assessment (CT or MRI)
Key exclusion criteria (1 listed)
- bilateral and multilevel disc prolapse, sequestrated , migrated and disc herniation defined by MRI , acute onset of pain (pain less than three months), presence of active infection in the lumbar spine, any spinal deformities e.g., moderate, or severe scoliosis deformity (Cobb angle ≥ 25°), postoperative cases, Cauda equine lesion, the presence of any comorbidities, history of patients who suffered from cancer, unexplained weight loss, immunosuppression, prolonged use of steroids, intravenous drug use, urinary tract infection, pain that is increased or unrelieved by rest, fever, significant trauma related to age, bladder or bowel incontinence, urinary retention (with overflow incontinence), saddle anesthesia, loss of anal sphincter tone, major motor weakness in lower extremities, fever, and vertebral tenderness
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 |
|---|---|---|
| Positioning techniqueFirst time of testing: Firstly, the patients were scanned in the conventional neutral supine position and a 3D-CT scan was taken. Second time of testing: after 10 minutes, the patients were scanned in the modified reversed contralateral rotation (side-lying on a hard pillow with side bending to the non-affected side and rotation to non affected side). This is achieved through instructing the participant to first lie on the side lying on a wedge pillow (that is flexible with dimensions of 30 cm in height and 75 cm in length) to achieve trunk side bending to non-affected side this pillow is the same for all patients, then the patient/participant rotated to the affected side (pelvis on the trunk rotation), and 3D-CT scan. Third time of testing: after 48 hours, the patients were scanned in the modified reversed contralateral rotation. | Other | positioning |
Primary outcome
Straight leg raising test
Time frame: 48 hours
With the patient in the supine position and the hips were neutral, neither abducted nor adducted nor rotated, the investigator lifted the leg slowly while the knee was kept in extended position. Each leg is raised separately until pain occurs. When the patient reported feeling radiating pain the angle between the bed and the leg was recorded by a goniometer
1 secondary outcome
Foraminal cross sectional area
Time frame: 48 hours
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 11 Apr 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positioning technique in people with Disc Prolapse With Radiculopathy, run by Noha Khaled Shoukry at 1 site in Egypt.
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 1 inclusion and 1 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 11 Apr 2024. 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 Egypt. 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?
Straight leg raising test (time frame: 48 hours). 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 11 Apr 2024.