Fluoroscopically-guided Versus Landmark-guided Sacroiliac Joint Injections

Sacroiliac Joint Pain Clinical Trial

Official title:

Randomized, Controlled, Double-blind, Comparative-effectiveness Study Comparing Fluoroscopically-guided and Landmark-guided Sacroiliac Joint Injections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096653
• Other study ID #: NA_00092414
• Status: Completed
• Phase: N/A
• First received: March 22, 2014
• Last updated: February 5, 2018
• Start date: May 2014
• Est. completion date: November 2017

Study information

• Verified date: February 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, the investigators are attempting to determine whether intra- or extra-articular injections are more effective; the relative prevalence rate of intra-articular and extra-articular SI joint pain; and the accuracy of extra-articular injections using fluoroscopy as the reference standard. 124 consecutive patients with mechanical low back pain below L5, tenderness overlying the SI joint(s) and at least 3 positive provocative maneuvers will be randomized to receive SI joint injections by 2 different approaches.

Group 1 will receive fluoroscopically-guided injections into the joint. Group 2 will receive landmark-guided injections into the tender area around the joint. In order to determine whether the injection in group 2 was intra-articular or extra-articular, an x-ray will be done after the injection to ascertain the location of contrast spread. The primary outcome measure will be pain relief at 1-month. Patients who obtain benefit at 1-month will be followed at 3-months, while those who fail to obtain benefit will exit the study to receive alternative care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Age > 18;

2. Low back pain principally below the L5 vertebra;

3. Three out of 6 positive SI joint provocative maneuvers;

4. Agreed to undergo SI joint injection for diagnostic/ therapeutic purposes;

5. Average pain score > 3/10 over the past week;

6. Pain duration > 6 weeks;

Exclusion Criteria:

1. Previous SI joint injection;

2. Leg pain > back pain or lower leg pain > upper leg pain

3. Active inflammatory spondyloarthropathy (e.g. ankylosing spondylitis);

4. Untreated coagulopathy;

5. Allergy to contrast dye or bupivacaine;

6. Pain > 20 years in duration;

7. Poorly controlled psychiatric (e.g. PTSD) or medical (congestive heart failure) condition

Related Conditions & MeSH terms

• Arthralgia
• Sacroiliac Joint Pain

Intervention

Procedure:
• X-ray SI joint steroid injection
Injection of steroid and local anesthetic into the joint cavity using fluoroscopic guidance
• Landmark-guided SI steroid injection
Injection of steroid into the joint area based on palpation. The injection may be inside the joint (intra-articular) or outside the joint in the ligaments (extra-articular)

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Penn State	Hershey	Pennsylvania
United States	Walter Reed National Military Medical Center	Rockville	Maryland
United States	Naval Hospital-San Diego	San Diego	California

Sponsors (5)

Lead Sponsor	Collaborator
Johns Hopkins University	Milton S. Hershey Medical Center, Uniformed Services University of the Health Sciences, United States Naval Medical Center, San Diego, Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cohen SP, Chen Y, Neufeld NJ. Sacroiliac joint pain: a comprehensive review of epidemiology, diagnosis and treatment. Expert Rev Neurother. 2013 Jan;13(1):99-116. doi: 10.1586/ern.12.148. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Back Pain at 1 Month Measured Using the Numeric Pain Scale	This outcome measure compares the average back pain at baseline to the average back pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The group receiving fluoroscopically-guided intra-articular injection is compared to the group receiving landmark-guided injections.	1 month from the start of treatment
Secondary	Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index	Functional capacity measured using Oswestry disability index. The range of possible scores for Oswestry Disability Index are 0-100. 0 is equated with no disability and 100 is the maximum disability possible.	1 month after the start of treatment
Secondary	Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale	This outcome measure compares the worst back pain at baseline to the worst back pain at 1 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The group receiving fluoroscopically-guided intra-articular injection is compared to the group receiving landmark-guided injections.	1 month from the start of treatment
Secondary	Average Back Pain at 3 Months Measured Using the Numeric Pain Scale	This outcome measure compares the average back pain at baseline to the average back pain at 3 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The group receiving fluoroscopically-guided intra-articular injection is compared to the group receiving landmark-guided injections.	3 months from the start of treatment
Secondary	Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale	This outcome measure compares the worst back pain at baseline to the worst back pain at 3 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The group receiving fluoroscopically-guided intra-articular injection is compared to the group receiving landmark-guided injections.	3 months after the start of treatment
Secondary	Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index	Functional capacity measured using Oswestry disability index. The range of possible scores for Oswestry Disability Index are 0-100. 0 is equated with no disability and 100 is the maximum disability possible.	3 months after the start of treatment
Secondary	Patient satisfaction of the procedure at 1 month measured using the Likert Scale	Patient satisfaction is measured at 1 month after the procedure using the Likert Scale. The range of possible scores for the Likert Scale are 1-5. I being very unsatisfied and 5 being very satisfied.	1 month
Secondary	Patient satisfaction of the procedure at 3 months measured using the Likert Scale	Patient satisfaction is measured at 1 month after the procedure using the Likert Scale. The range of possible scores for the Likert Scale are 1-5. I being very unsatisfied and 5 being very satisfied.	3 months
Secondary	Positive categorical outcome	Decrease in average back pain score at 1 month of greater or equal to 2 points coupled with a satisfaction score > 3 on a 1-5 scale	1 month
Secondary	Positive categorical outcome	Decrease in average back pain score at 3 months of greater or equal to 2 points coupled with a satisfaction score > 3 on a 1-5 scale	3 months
Secondary	Positive diagnostic blocks	The percentage of participants who experience greater or equal to 50% pain relief based on their pain diary	6 hours