Back to resultsCombination of Fluoroscopy and Ultrasonography Guidance in Sacroiliac Joint Injections
Primary Purpose
Sacroiliac Joint Somatic Dysfunction, Sacroiliac Joint Pain
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Combined ultrasonography and flouroscopy guided injeciton
Flouroscopy guided injection
Sponsored by
About this trial
This is an interventional treatment trial for Sacroiliac Joint Somatic Dysfunction focused on measuring Sacroiliac joint pain, Sacroiliac joint injection, Ultrasonography guided injection, Flouroscopy guided injection
Eligibility Criteria
Inclusion Criteria: Low back and/or gluteal pain and/or groin pain without radicular extension below the L4 level for more than 3 months Pain score greater than 3 according to NRS Unresponsiveness to conservative treatment (such as exercise, NSAID) At least 3 of the five sacroiliac provocation tests (FABER (Patrick), thigh thrust, Gaenslen, sacroiliac compression, and sacroiliac distraction tests) are positive Exclusion Criteria: Refusing to participate in the study Pregnancy Infective sacroiliitis Malignancy Osteoporosis Mechanical lumbosacral pathologies (spondylolisthesis, scoliosis, stenosis, etc.) Neurological finding in the lower extremity Pain spreading below the knee History of spinal surgery History of allergy to drugs to be injected (local anesthetic, contrast material, steroid allergy)
Sites / Locations
- SBU,Gaziler Physical Medicine and Rehabilitation Education and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Combined ultrasonography and flouroscopy guided injeciton
Flouroscopy guided injection
Arm Description
In 17 patients selected after randomization, the procedure will first be started with ultrasound and then continued with fluoroscopy.
In 17 patients selected after randomization, the procedure will be performed only through fluoroscopy.
Outcomes
Primary Outcome Measures
Processing Time
The processing time will be measured by the other researcher in the processing room with the help of a stopwatch. The stopwatch will be started when the needle touches the patient and will be stopped when the procedure is finished. It will be recorded in seconds
Secondary Outcome Measures
Fluoroscopy Time
The fluoroscopy time applied to the patient is automatically measured by the fluoroscopy device. This data will be saved
Kerma-area Product (μGy)
The kerma area product will be measured to measure the radiation level to which the patient is exposed. This data is automatically measured by the fluoroscopy device.
Visual Analogue Scale
Severity of pain was assessed using the standard 10 point VAS with 0 meant "no pain" at one end, and 10 meant "unbearable pain" at the other end
Oswestry Low Back Pain Disability Questionnaire
The Oswestry disability index will be used to evaluate how much the patients' low back pain limits their activities in daily life. This index was first created in 1980 . The questionnaire consists of 10 sections, each assessing limitations in different daily activities and functions. Each section is scored from 0 to 5. A score of 0 indicates that there is no restriction while doing that activity, while a score of 5 represents the highest level of restriction in that activity. The maximum score is 50. As the total score increases, the disability level of the individual increases. In 2004, Turkish validity study was carried out by Yakut et al.
Full Information
NCT ID
NCT05944861
First Posted
March 15, 2023
Last Updated
July 12, 2023
Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05944861
Brief Title
Combination of Fluoroscopy and Ultrasonography Guidance in Sacroiliac Joint Injections
Official Title
Combination of Fluoroscopy and Ultrasonography Guidance in Sacroiliac Joint Injections: Effect on Procedure Time and Radiation Exposure
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2023 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of this study is to investigate the effect of the application of sacroiliac joint injection guided by combination of ultrasonography and fluoroscopy on the duration of the procedure and the amount of radiation exposed during the procedure, compared to the application of only fluoroscopy-guided technique. Secondary objectives are to evaluate the effectiveness of the treatment with both methods and to record the adverse events that may be encountered during the procedure.
Detailed Description
The study was designed as prospective, randomized, controlled trial. The patients who meet the eligibility requirements will be randomized into two groups in a 1:1 ratio to fluoroscopy and ultrasound+fluoroscopy. Processing time will be recorded during injection. "Fluoroscopy time" (sec) and "kerma-area product" (μGy) automatically measured by the fluoroscopy device will be used to evaluate the radiation exposure. Pre-procedural visual analogue scale (VAS) scores and Oswestry Disability Index (ODI) values were noted all the patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacroiliac Joint Somatic Dysfunction, Sacroiliac Joint Pain
Keywords
Sacroiliac joint pain, Sacroiliac joint injection, Ultrasonography guided injection, Flouroscopy guided injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Combined ultrasonography and flouroscopy guided injeciton
Arm Type
Experimental
Arm Description
In 17 patients selected after randomization, the procedure will first be started with ultrasound and then continued with fluoroscopy.
Arm Title
Flouroscopy guided injection
Arm Type
Active Comparator
Arm Description
In 17 patients selected after randomization, the procedure will be performed only through fluoroscopy.
Intervention Type
Other
Intervention Name(s)
Combined ultrasonography and flouroscopy guided injeciton
Intervention Description
In the ultrasound+fluoroscopy group, the sacroiliac injection will be started under ultrasound guidance. With the help of ultrasound, when sacral 2 foramen is seen the needle will be advanced to the entrance of the sacroiliac joint under real-time in-plane view. After considering intra-articular placement, fluoroscopy guidance will be initiated. An anteroposterior image will be taken to confirm whether contrast material is within the joint. If intra-articular placement is not achieved after contrast medium infiltration, needle reposition will be performed under fluoroscopy for correct needle placement. After the intraarticular contrast pattern is seen, 1 ml of 40 mg methylprednisolone + 1 ml of 1% lidocaine mixture will be injected.
Intervention Type
Other
Intervention Name(s)
Flouroscopy guided injection
Intervention Description
In the fluoroscopy group, the advancement of the needle into the sacroiliac joint will be performed by taking anteroposterior and lateral views. In the same way, the needle tip will be placed in the inferior of the sacroiliac joint, and contrast material distribution examination and injection of the drug will be performed as in the ultrasound + fluoroscopy group.
Primary Outcome Measure Information:
Title
Processing Time
Description
The processing time will be measured by the other researcher in the processing room with the help of a stopwatch. The stopwatch will be started when the needle touches the patient and will be stopped when the procedure is finished. It will be recorded in seconds
Time Frame
during the intervention
Secondary Outcome Measure Information:
Title
Fluoroscopy Time
Description
The fluoroscopy time applied to the patient is automatically measured by the fluoroscopy device. This data will be saved
Time Frame
during the intervention
Title
Kerma-area Product (μGy)
Description
The kerma area product will be measured to measure the radiation level to which the patient is exposed. This data is automatically measured by the fluoroscopy device.
Time Frame
during the intervention
Title
Visual Analogue Scale
Description
Severity of pain was assessed using the standard 10 point VAS with 0 meant "no pain" at one end, and 10 meant "unbearable pain" at the other end
Time Frame
baseline, change from baseline VAS at 1 month after intervention
Title
Oswestry Low Back Pain Disability Questionnaire
Description
The Oswestry disability index will be used to evaluate how much the patients' low back pain limits their activities in daily life. This index was first created in 1980 . The questionnaire consists of 10 sections, each assessing limitations in different daily activities and functions. Each section is scored from 0 to 5. A score of 0 indicates that there is no restriction while doing that activity, while a score of 5 represents the highest level of restriction in that activity. The maximum score is 50. As the total score increases, the disability level of the individual increases. In 2004, Turkish validity study was carried out by Yakut et al.
Time Frame
baseline, change from baseline VAS at 1 month after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Low back and/or gluteal pain and/or groin pain without radicular extension below the L4 level for more than 3 months
Pain score greater than 3 according to NRS
Unresponsiveness to conservative treatment (such as exercise, NSAID)
At least 3 of the five sacroiliac provocation tests (FABER (Patrick), thigh thrust, Gaenslen, sacroiliac compression, and sacroiliac distraction tests) are positive
Exclusion Criteria:
Refusing to participate in the study
Pregnancy
Infective sacroiliitis
Malignancy
Osteoporosis
Mechanical lumbosacral pathologies (spondylolisthesis, scoliosis, stenosis, etc.)
Neurological finding in the lower extremity
Pain spreading below the knee
History of spinal surgery
History of allergy to drugs to be injected (local anesthetic, contrast material, steroid allergy)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serdar KESIKBURUN, MD
Phone
+903122911402
Email
serdarkb@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmet Onur CAKIRYILMAZ, MD
Phone
+905333873359
Email
ocakiryilmaz@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serdar KESIKBURUN, MD
Organizational Affiliation
SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
City
Ankara
State/Province
Cankaya
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serdar KESIKBURUN, MD, Associate Professor
Phone
+903122911402
Email
serdarkb@gmail.com
First Name & Middle Initial & Last Name & Degree
Ahmet Onur CAKIRYILMAZ, MD
Phone
+905333873359
Email
ocakiryilmaz@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Combination of Fluoroscopy and Ultrasonography Guidance in Sacroiliac Joint Injections
We'll reach out to this number within 24 hrs