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Trial Outcomes & Findings for Particulate Corticosteroid Versus Non-particulate Corticosteroid for Sacroiliac Joint Injection (NCT NCT03166761)

NCT ID: NCT03166761

Last Updated: 2024-07-10

Results Overview

Numeric pain rating score, 11 point scale (0-10) filled out on a form indicating the degree of relief/discomfort after the injection. Pain was assessed monthly from baseline to 3 months following the injection. The average value at month 3 is reported.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

41 participants

Primary outcome timeframe

Baseline to 3 months; Average value at month 3 reported

Results posted on

2024-07-10

Participant Flow

18 of the 41 patients enrolled had a negative diagnostic response to initial injection and were not followed due to the negative screen after enrollment

Participant milestones

Participant milestones
Measure
Dexamethasone
dexamethasone injected into the sacroiliac joint Dexamethasone: Dexamethasone injection into the sacroiliac joint
Triamcinolone
triamcinolone injected into the sacroiliac joint Triamcinolone Acetonide: Triamcinolone injection into the sacroiliac joint
Overall Study
STARTED
9
14
Overall Study
COMPLETED
9
10
Overall Study
NOT COMPLETED
0
4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Particulate Corticosteroid Versus Non-particulate Corticosteroid for Sacroiliac Joint Injection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Dexamethasone
n=9 Participants
dexamethasone injected into the sacroiliac joint Dexamethasone: Dexamethasone injection into the sacroiliac joint
Triamcinolone
n=14 Participants
triamcinolone injected into the sacroiliac joint Triamcinolone Acetonide: Triamcinolone injection into the sacroiliac joint
Total
n=23 Participants
Total of all reporting groups
Age, Continuous
59.8 years
STANDARD_DEVIATION 19.1 • n=5 Participants
56.5 years
STANDARD_DEVIATION 15.7 • n=7 Participants
57.8 years
STANDARD_DEVIATION 16.8 • n=5 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
9 Participants
n=7 Participants
14 Participants
n=5 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
5 Participants
n=7 Participants
9 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
White
9 Participants
n=5 Participants
13 Participants
n=7 Participants
22 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 3 months; Average value at month 3 reported

Numeric pain rating score, 11 point scale (0-10) filled out on a form indicating the degree of relief/discomfort after the injection. Pain was assessed monthly from baseline to 3 months following the injection. The average value at month 3 is reported.

Outcome measures

Outcome measures
Measure
Dexamethasone
n=9 Participants
dexamethasone injected into the sacroiliac joint Dexamethasone: Dexamethasone injection into the sacroiliac joint
Triamcinolone
n=10 Participants
triamcinolone injected into the sacroiliac joint Triamcinolone Acetonide: Triamcinolone injection into the sacroiliac joint
Pain Using Numeric Pain Rating Score
4.2 units on a scale
Standard Deviation 2.7
4.4 units on a scale
Standard Deviation 2.1

Adverse Events

Dexamethasone

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Triamcinolone

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Byron Schneider

Vanderbilt University Medical Center

Phone: (615)936-7708

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place