Skip to main content
OpenTrials
Completed

NCT Number: NCT02096653

Fluoroscopically-guided Versus Landmark-guided Sacroiliac Joint Injections

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sacroiliac Joint Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naval Hospital-San Diego, San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18;
  • Low back pain principally below the L5 vertebra;
  • Three out of 6 positive SI joint provocative maneuvers;
  • Agreed to undergo SI joint injection for diagnostic/ therapeutic purposes;
  • Average pain score > 3/10 over the past week;
  • Pain duration > 6 weeks;

Exclusion criteria

  • Previous SI joint injection;
  • Leg pain > back pain or lower leg pain > upper leg pain
  • Active inflammatory spondyloarthropathy (e.g. ankylosing spondylitis);
  • Untreated coagulopathy;
  • Allergy to contrast dye or bupivacaine;
  • Pain > 20 years in duration;
  • Poorly controlled psychiatric (e.g. PTSD) or medical (congestive heart failure) condition

Treatment and study plan

X-ray SI joint steroid injection

Procedure

Injection of steroid and local anesthetic into the joint cavity using fluoroscopic guidance

Landmark-guided SI steroid injection

Procedure

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)

Primary outcomes

  1. Average Back Pain at 1 Month Measured Using the Numeric Pain Scale

    Time frame: 1 month from the start of treatment

    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.

Secondary outcomes

  1. Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index

    Time frame: 1 month after the start of treatment

    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.

  2. Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale

    Time frame: 1 month from the start of treatment

    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.

  3. Average Back Pain at 3 Months Measured Using the Numeric Pain Scale

    Time frame: 3 months from the start of treatment

    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.

  4. Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale

    Time frame: 3 months after the start of treatment

    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.

  5. Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index

    Time frame: 3 months after the start of treatment

    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.

  6. Patient satisfaction of the procedure at 1 month measured using the Likert Scale

    Time frame: 1 month

    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.

  7. Patient satisfaction of the procedure at 3 months measured using the Likert Scale

    Time frame: 3 months

    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.

  8. Positive categorical outcome

    Time frame: 1 month

    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

  9. Positive categorical outcome

    Time frame: 3 months

    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

  10. Positive diagnostic blocks

    Time frame: 6 hours

    The percentage of participants who experience greater or equal to 50% pain relief based on their pain diary

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 26, 2014
Registry last updated
Feb 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.