Evaluation the Impact of the "Pas" Technique Versus the "Standard" Technique on Radiation Exposure

Evaluation the Impact of the "Pas" Technique Versus the "Standard" Technique on Radiation Exposure, Procedure Efficiency, and Patient Outcome in Pain Management Injections

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 distances from the needles and place them all together using our initial target needle marker in the objective anatomic landmark. Will randomized patients assigning them either in cohort 1 control "Standard" of care technique and cohort 2 "PAS" technique. After only utilizing the "Standard" of care technique, will obtain the measurements and distances from the needles inserted in patients under fluoroscopic guidance for the different pain procedures. The data will help demonstrate that is possible to predict the needle placement replicating with confidence good outcomes using the "PAS" technique to reduce the radiation exposure and time. Our data will justify the use of the "PAS" technique to become an alternative to the "Standard" of care technique for a faster, efficient, and replicable needle placement for diminished radiation exposure, to avoid complications and consistent good outcomes

Study Overview

• Status: Completed
• Conditions: Back Pain; Spine; Fluoroscopy for Spine Surgery; Sacroiliac Joint
• Intervention / Treatment: Procedure: Standard Technique; Procedure: PAS Technique

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 different number of needle injection sites as needed.

Timer: Begin stopwatch for entire procedure from start to medication insertion. Positioning: The patient is placed in a prone position on the fluoroscopic table. Time out was performed.

Skin Preparation: Clean the injection site with an antiseptic solution and drape it to maintain sterility.

Anesthesia: Administer intravenous sedation Identification of Anatomical Landmark:The spinous process was located and marked as the reference point (SP), which was then used as a guide for the following steps.

Marking Target Points: Using the spinous process (SP) as the anatomical landmark and X-ray guided fluoroscopy, Target Point 1 (TP1) was identified and its position verified. The X value (the horizontal distance from the SP to TP1) was measured. This X value was not just a guide but the exact horizontal distance used for the placement of all subsequent target points. For the vertical distance between target points, a consistent distance of 3 cm was applied. This value was determined as the average vertical distance between the target points based on prior findings.

Refer to Figure 2 for a detailed illustration of the target point positions in relation to the spinous process and the distances applied.

Horizontal Distance (X Values):

The X value represents the horizontal distance from the spinous process (SP) to each target point (TP).

The X value measured for TP1 was used as the fixed horizontal distance for all target points on both sides of the SP.

For target points on the opposite side of the SP, the same X value was mirrored.

Thus, for the entire procedure:

TP1 and TP4 were placed at an equal X distance to the right and left of the SP, respectively.

TP2 and TP5 followed the same X distance as TP1 and TP4, located on their respective sides of the SP.

Vertical Distance (Y Values):

The Y value represents the vertical distance between the target points. A consistent vertical distance was applied between the target points. This was determined as the average distance between the target points based on prior findings.

Therefore:

TP2 was positioned 3 cm below TP1. TP3 was positioned 3 cm above TP1. TP5 was positioned 3 cm below TP4. TP6 was positioned 3 cm above TP4.

Final Verification: One final fluoroscopic image was taken to verify the accurate placement of all needles at the marked target points.

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Merced, California, United States, 95340
      • University Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

**Inclusion Criteria:**

• 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 Criteria:**

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Technique; Standard Technique is the standard protocol for the pain management procedures completed in this study such as Medical Branch Block, Radiofrequency Ablation, Sacroiliac Joint Block, and Transforaminal Epidural	Procedure: Standard Technique; In the "Standard" or "Traditional "technique, the spinal needles are used to localize the anatomical objective using fluoroscopic guidance for each needle placement. Traditionally, each needle is placed individually with a spot radiological view before placement and after placement of each needle to confirm the localization.
Experimental: PAS Technique; 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 different number of needle injection sites as needed. Timer: Begin stopwatch for entire procedure from start to medication insertion. Positioning: The patient is placed in a prone position on the fluoroscopic table. Time out was performed. Skin Preparation: Clean the injection site with an antiseptic solution and drape it to maintain sterility. Anesthesia: Administer intravenous sedation Identification of Anatomical Landmark:The spinous process was located and marked as the reference point (SP), which was then used as a guide for the following steps. Marking Target Points: Using the spinous process (SP) as the anatomical landmark and X-ray guided fluoroscopy, Target Point 1 (TP1) was identified and its position verified. The X value (the horizontal distance from the SP to TP1) was measured.	Procedure: PAS Technique; 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 different number of needle injection sites as needed. Timer: Begin stopwatch for entire procedure from start to medication insertion. Positioning: The patient is placed in a prone position on the fluoroscopic table. Time out was performed. Skin Preparation: Clean the injection site with an antiseptic solution and drape it to maintain sterility. Anesthesia: Administer intravenous sedation Identification of Anatomical Landmark:The spinous process was located and marked as the reference point (SP), which was then used as a guide for the following steps. Marking Target Points: Using the spinous process (SP) as the anatomical landmark and X-ray guided fluoroscopy, Target Point 1 (TP1) was identified and its position verified. The X value (the horizontal distance from the SP to TP1) was measured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation Exposure	Examined Radiation Exposure amount from Fluoroscopic Guidance on Patient	through study completion, an average of 6 months
Radiation Exposure	radiation exposure from the fluoroscopy dosage logbook	During the index procedure (from first fluoroscopy activation to last activation on Day 0; ≤ 20 min)
Procedure length in time	Total Procedure Time	During the index procedure (from anesthesia induction to application of the final bandage after injection on Day 0; measured in minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Pain Scale	Examined Pain Index's before and After procedure Numeric Pain Scale from 1-10, one being the least pain and ten being the most- higher the pain score, the worse the outcome.	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Orthospine Advance Health, Inc.
• Investigators: Study Chair: Mary Oster, Metrowest IRB Chair, Metro West Medical Center

Publications and helpful links

General Publications

• Patel K, Chopra P, Martinez S, Upadhyayula S. Epidural Steroid Injections. 2024 Jun 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470189/

Helpful Links

• Epidural Steroid Injections

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): May 15, 2024
• Study Completion (Actual): May 15, 2024

Study Registration Dates

• First Submitted: November 3, 2024
• First Submitted That Met QC Criteria: April 6, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 6, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Spine; PAS
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: IRB#2023-099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Investigators have no reason to disclose participant data but if requested, investigators will share data using the correct necessary steps protecting patient privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No