the Modified Reversed Contralateral Axial Rotation Position

NCT06359470 | Completed

• 1 other identifier: CaiUni
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Disc Prolapse With Radiculopathy

Outcome Measures

Primary Outcomes (1)

• 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

  48 hours

Secondary Outcomes (1)

• Foraminal cross sectional area

  48 hours

Study Arms (1)

positioning

EXPERIMENTAL

the supine position, then from the oblique position after 10 minutes, and finally from the oblique position again after 48 hours

Other: Positioning technique

Interventions

Positioning technique OTHER

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.

positioning

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Noha Khaled Shoukry: lead

Study Sites (1)

Faculty of Physical Therapy

Giza, 12556, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer

Model Details: 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

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 11, 2024
• Study Start: November 5, 2022
• Primary Completion: October 1, 2023
• Study Completion: January 14, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)