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

NCT06918197 | Completed

• 1 other identifier: IRB#2023-099
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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 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

Conditions

Spine; Fluoroscopy for Spine Surgery; Back Pain; Sacroiliac Joint

Keywords

Spine; PAS

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Numeric Pain Scale

  through study completion, an average of 6 months

Study Arms (2)

Standard Technique

ACTIVE COMPARATOR

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

PAS Technique

EXPERIMENTAL

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

Interventions

PAS Technique PROCEDURE

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.

PAS Technique

Standard Technique PROCEDURE

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.

Standard Technique

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orthospine Advance Health, Inc.: lead

Study Sites (1)

University Surgery Center

Merced, California, 95340, United States

Location

Related Publications (1)

• 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/

  PMID: 29262183 BACKGROUND

Related Links

• Epidural Steroid Injections

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary Oster, Metrowest IRB Chair

  Metro West Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Spinal Surgeon, Principal Investigator

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: April 9, 2025
• Study Start: October 1, 2023
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)