Status:
COMPLETED
Evaluation the Impact of the "Pas" Technique Versus the "Standard" Technique on Radiation Exposure
Lead Sponsor:
Orthospine Advance Health, Inc.
Conditions:
Spine
Fluoroscopy for Spine Surgery
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare both techniques and analyze the data from the "Standard" technique to help design the "PAS" technique. In the "PAS" technique, investigators predetermine the di...
Detailed Description
PAS Technique Protocol: The following steps outline the PAS Technique. While the example below uses 6 injection sites, the approach can be adapted for different pain management procedures with a diff...
Eligibility Criteria
Inclusion
- \*\*\*\*
- Adult patients aged 19 and older
- No history of:
- Convictions
- Infections
- Cancer
- Contraindications for surgical procedures
- Patients scheduled for pain injections who:
- Agree to participate in the study
- Sign informed consent and IRB approval consent
- Complete preoperative, postoperative, and 1-week postoperative questionnaires
- Patients with chronic lower back pain (lasting over three months) that has not responded to conventional treatments (e.g., NSAIDs, back muscle strengthening, physiotherapy)
- Symptoms indicating facet pain, including:
- Lower back pain with or without radiation to the buttocks, thigh, or groin
- Pain increasing on hyperextension
- Pain during initial movements
- Focal tenderness over the facet joint when pressed
- Post-lumbar disc surgery patients with persistent pain but no MRI evidence of arachnoiditis or infection
- All procedures conducted under fluoroscopic guidance for spinal needle placement
- Data collection parameters:
- Gender, race, height, weight, BMI
- Radiation exposure from fluoroscopy dosage logbook
- Procedure time
- Horizontal and longitudinal distance measurements between spinal levels (in cm)
- Study period: October 1, 2023, to May 15, 2024
- \*\*
Exclusion
- \*\*
- Evidence of:
- Infection (elevated WBC \>12,000 or UTI)
- Neoplastic disease
- Possible pregnancy, bleeding diathesis, or anticoagulant therapy
- History of sensitivity to local anesthetics
- \*\*Preoperative and Postoperative Assessments:\*\*
- Visual Analog Scale (VAS)
- Numeric Pain Scale
- Disability Oswestry Index questionnaires
- Additional data collection for both cohorts:
- Patient demographics (age, gender, race, height, weight, BMI)
- Radiation exposure from fluoroscopy (in mGy)
- Procedure duration
- Horizontal and vertical distance measurements (in cm) between spinal needle placements
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2024
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT06918197
Start Date
October 1 2023
End Date
May 15 2024
Last Update
April 9 2025
Active Locations (1)
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1
University Surgery Center
Merced, California, United States, 95340