Trial Outcomes & Findings for Pain Outcomes Following Intralesional Corticosteroid Injections (NCT NCT03630198)

NCT ID: NCT03630198

Last Updated: 2021-03-11

Results Overview

Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 31 participants
• Primary outcome timeframe: Assessed 1 minute after the injection (in clinic)
• Results posted on: 2021-03-11

Participant Flow

Participant milestones

Measure	Corticosteroid With Lidocaine This arm will include an injection mixture of corticosteroid and lidocaine Corticosteroid with lidocaine: Intralesional corticosteroid injection	Corticosteroid With Normal Saline This arm will include a mixture of corticosteroid and normal saline. The purpose of normal saline is to keep the volume and concentration similar when compared to the injections containing lidocaine. Corticosteroid with normal saline: Intralesional corticosteroid injection
Overall Study STARTED	13	18
Overall Study COMPLETED	13	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Corticosteroid With Lidocaine n=13 Participants This arm will include an injection mixture of corticosteroid and lidocaine Corticosteroid with lidocaine: Intralesional corticosteroid injection	Corticosteroid With Normal Saline n=18 Participants This arm will include a mixture of corticosteroid and normal saline. The purpose of normal saline is to keep the volume and concentration similar when compared to the injections containing lidocaine. Corticosteroid with normal saline: Intralesional corticosteroid injection	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=13 Participants	0 Participants n=18 Participants	0 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=13 Participants	18 Participants n=18 Participants	31 Participants n=31 Participants
Age, Categorical >=65 years	0 Participants n=13 Participants	0 Participants n=18 Participants	0 Participants n=31 Participants
Age, Continuous	33 years STANDARD_DEVIATION 18.2 • n=13 Participants	52 years STANDARD_DEVIATION 19.2 • n=18 Participants	43 years STANDARD_DEVIATION 20.3 • n=31 Participants
Sex: Female, Male Female	6 Participants n=13 Participants	10 Participants n=18 Participants	16 Participants n=31 Participants
Sex: Female, Male Male	7 Participants n=13 Participants	8 Participants n=18 Participants	15 Participants n=31 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	13 Participants n=13 Participants	18 Participants n=18 Participants	31 Participants n=31 Participants

PRIMARY outcome

Timeframe: Assessed 1 minute after the injection (in clinic)

Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever.

Outcome measures

Measure	Corticosteroid With Lidocaine n=13 Participants This arm will include an injection mixture of corticosteroid and lidocaine Corticosteroid with lidocaine: Intralesional corticosteroid injection	Corticosteroid With Normal Saline n=18 Participants This arm will include a mixture of corticosteroid and normal saline. The purpose of normal saline is to keep the volume and concentration similar when compared to the injections containing lidocaine. Corticosteroid with normal saline: Intralesional corticosteroid injection
Pain Outcome: Visual Analog Scale	5.4 Score on a scale Standard Deviation 2.4	2.7 Score on a scale Standard Deviation 2.3

POST_HOC outcome

Timeframe: Assessed at 6 hours and 24 hours after injection

Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever.

Outcome measures

Measure	Corticosteroid With Lidocaine n=13 Participants This arm will include an injection mixture of corticosteroid and lidocaine Corticosteroid with lidocaine: Intralesional corticosteroid injection	Corticosteroid With Normal Saline n=18 Participants This arm will include a mixture of corticosteroid and normal saline. The purpose of normal saline is to keep the volume and concentration similar when compared to the injections containing lidocaine. Corticosteroid with normal saline: Intralesional corticosteroid injection
Pain Outcome: Visual Analog Scale Pain (6 hour)	0.9 Score on a scale Standard Deviation 2.1	0.1 Score on a scale Standard Deviation 1.5
Pain Outcome: Visual Analog Scale Pain (24 hour)	0 Score on a scale Standard Deviation 0	0 Score on a scale Standard Deviation 0

Adverse Events

Corticosteroid With Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Corticosteroid With Normal Saline

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

Dr. Brian Drolet

Vanderbilt Univeristy Medical center

Phone: 615-322-2918

Email: brian.c.drolet@vumc.org

Results disclosure agreements

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