SpineNCT06918197
Evaluation the Impact of the "Pas" Technique Versus the "Standard" Technique on Radiation Exposure
A study testing PAS Technique and Standard Technique in people with Spine and Fluoroscopy for Spine Surgery, run by Orthospine Advance Health, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Spine, Fluoroscopy for Spine Surgery, Back Pain
- What is being tested?
- PAS Technique and Standard Technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 19 and older
- No history of:
- Convictions
- Infections
- Cancer
- Contraindications for surgical procedures
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- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Spine, Fluoroscopy for Spine Surgery, Back Pain, Sacroiliac Joint
- Being tested
- PAS Technique, Standard Technique
- Keywords
- Spine, PAS
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAS TechniqueProcedure or surgery
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.
Standard TechniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: PAS Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation Exposure
Examined Radiation Exposure amount from Fluoroscopic Guidance on Patient
Measured: through study completion, an average of 6 months
Radiation Exposure
radiation exposure from the fluoroscopy dosage logbook
Measured: During the index procedure (from first fluoroscopy activation to last activation on Day 0; ≤ 20 min)
Procedure length in time
Total Procedure Time
Measured: 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
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.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Oct 2023
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SpineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthospine Advance Health, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Garcia-Diaz, Mercy Medical Center
- Investigators
- Mary Oster, Metrowest IRB Chair, Study chair, Metro West Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918197
- Sponsor's protocol ID
- IRB#2023-099
- Status last verified
- Apr 2025
- First submitted
- 3 Nov 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Investigators have no reason to disclose participant data but if requested, investigators will share data using the correct necessary steps protecting patient privacy.
Publications
Patel K, Chopra P, Martinez S, Upadhyayula S. Epidural Steroid Injections. 2024 Jun 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470189/
PubMed 29262183
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Impact of the "Pas" Technique Versus the "Standard" Technique on Radiation Exposure, Procedure Efficiency, and Patient Outcome in Pain Management Injections
- ClinicalTrials.gov ID
- NCT06918197
- Acronym / sponsor ID
- IRB#2023-099
- Conditions
- Spine, Fluoroscopy for Spine Surgery, Back Pain, Sacroiliac Joint
- Keywords
- Spine, PAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Orthospine Advance Health, Inc.University, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Technique | Active comparator | Procedure: Standard TechniqueStandard 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 |
| PAS Technique | Experimental | Procedure: PAS TechniquePAS 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Adult patients aged 19 and older
- No history of:
- Convictions
- Infections
- Cancer
Key exclusion criteria (14 listed)
- Evidence of:
- Infection (elevated WBC >12,000 or UTI)
- Neoplastic disease
- Possible pregnancy, bleeding diathesis, or anticoagulant therapy
- History of sensitivity to local anesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAS TechniquePAS 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 or surgery | PAS Technique |
| Standard TechniqueIn 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. | Procedure or surgery | Standard Technique |
Primary outcome
Radiation Exposure
Time frame: through study completion, an average of 6 months
Examined Radiation Exposure amount from Fluoroscopic Guidance on Patient
Radiation Exposure
Time frame: During the index procedure (from first fluoroscopy activation to last activation on Day 0; ≤ 20 min)
radiation exposure from the fluoroscopy dosage logbook
Procedure length in time
Time frame: During the index procedure (from anesthesia induction to application of the final bandage after injection on Day 0; measured in minutes)
Total Procedure Time
1 secondary outcome
Numeric Pain Scale
Time frame: through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Background: PubMed 29262183Patel K, Chopra P, Martinez S, Upadhyayula S. Epidural Steroid Injections. 2024 Jun 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470189/
- Epidural Steroid InjectionsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Investigators have no reason to disclose participant data but if requested, investigators will share data using the correct necessary steps protecting patient privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Oster, Metrowest IRB Chair study chair
Metro West Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAS Technique and Standard Technique in people with Spine and Fluoroscopy for Spine Surgery, run by Orthospine Advance Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation Exposure (time frame: through study completion, an average of 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06918197, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.