Clinical trial NCT06359470: the Modified Reversed Contralateral Axial Rotation Position
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disc Prolapse With Radiculopathy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 90
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention 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
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Straight leg raising test
timeFrame: 48 hours
Secondary outcomes:
measure: Foraminal cross sectional area
timeFrame: 48 hours
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
References: