Trial Outcomes & Findings for Ultrasound-guided Injection for DeQuervain's (NCT NCT02038634)

Results Overview

Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire. Questions 1-30, the scale is a 1-5 scale (1=no difficulty; 2=mild difficulty; 3=moderate difficulty; 4=severe difficulty; 5=unable) DASH Disability/Symptom Score = \[(sum of n responses)/n) -1\] x 25. A lower score is a better outcome. The Dash is based on a scale of 0-100. Our scores were averaged and the Mean scores are what we reported. Total scores are listed below. US Guided Group - Dash #1 (Min=25, Mean=58, Max=90) n=12; Dash #2 (Min=3, Mean=38, Max=91) n=12; Dash #3 (Min=6, Mean=42, Max=71) n=10; 1 Year Dash (Min=0, Mean =29, Max=91) n=12. Non-US Guided Group - Dash #1 (Min=23, Mean=39, Max=61) n=3; Dash #2 (Min=0, Mean=11, Max=22) n=3; Dash #3 (Min=7, Mean=30, Max=49) n=3; 1 Year Dash (Min=0, Mean=9, Max=25) n=3.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

16 participants

Primary outcome timeframe

Prior to injection (Dash #1), 6-8 weeks (Dash #2), 12-16 weeks (Dash #3), and 1 year (Dash #4) post-injection

Results posted on

2022-12-28

Participant Flow

Participants were recruited based by the PI between August 2013 and April 2021. The first participant was enrolled on August 5, 2014 and the last participant was enrolled on December 9, 2018

16 met inclusion criteria and were randomized to treatment.

Participant milestones

Participant milestones
Measure	Unguided Injections Corticosteroid injection (betamethasone) without ultrasound guidance. Betamethasone	Ultrasound-guided Injections Corticosteroid injections (betamethasone) under ultrasound guidance. Betamethasone Ultrasound: Ultrasound guided injection using GE Healthcare LOGIQ e Ultrasound
Overall Study STARTED	3	13
Overall Study COMPLETED	3	12
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Unguided Injections Corticosteroid injection (betamethasone) without ultrasound guidance. Betamethasone	Ultrasound-guided Injections Corticosteroid injections (betamethasone) under ultrasound guidance. Betamethasone Ultrasound: Ultrasound guided injection using GE Healthcare LOGIQ e Ultrasound
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Unguided Injections n=3 Participants Corticosteroid injection (betamethasone) without ultrasound guidance. Betamethasone	Ultrasound-guided Injections n=13 Participants Corticosteroid injections (betamethasone) under ultrasound guidance. Betamethasone Ultrasound: Ultrasound guided injection using GE Healthcare LOGIQ e Ultrasound	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=3 Participants	0 Participants n=13 Participants	0 Participants n=16 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=3 Participants	11 Participants n=13 Participants	13 Participants n=16 Participants
Age, Categorical >=65 years	1 Participants n=3 Participants	2 Participants n=13 Participants	3 Participants n=16 Participants
Sex: Female, Male Female	2 Participants n=3 Participants	13 Participants n=13 Participants	15 Participants n=16 Participants
Sex: Female, Male Male	1 Participants n=3 Participants	0 Participants n=13 Participants	1 Participants n=16 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Prior to injection (Dash #1), 6-8 weeks (Dash #2), 12-16 weeks (Dash #3), and 1 year (Dash #4) post-injection

Population: We enrolled 3 subjects into the Unguided Injection Arm and 13 subjects into the Ultrasound-Guided Injection Arm, however no further data was analyzed due to early termination of study.

Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire. Questions 1-30, the scale is a 1-5 scale (1=no difficulty; 2=mild difficulty; 3=moderate difficulty; 4=severe difficulty; 5=unable) DASH Disability/Symptom Score = \[(sum of n responses)/n) -1\] x 25. A lower score is a better outcome. The Dash is based on a scale of 0-100. Our scores were averaged and the Mean scores are what we reported. Total scores are listed below. US Guided Group - Dash #1 (Min=25, Mean=58, Max=90) n=12; Dash #2 (Min=3, Mean=38, Max=91) n=12; Dash #3 (Min=6, Mean=42, Max=71) n=10; 1 Year Dash (Min=0, Mean =29, Max=91) n=12. Non-US Guided Group - Dash #1 (Min=23, Mean=39, Max=61) n=3; Dash #2 (Min=0, Mean=11, Max=22) n=3; Dash #3 (Min=7, Mean=30, Max=49) n=3; 1 Year Dash (Min=0, Mean=9, Max=25) n=3.

Outcome measures

Outcome measures
Measure	Unguided Injections n=3 Participants Corticosteroid injection (betamethasone) without ultrasound guidance. Betamethasone	Ultrasound-guided Injections n=13 Participants Corticosteroid injections (betamethasone) under ultrasound guidance. Betamethasone Ultrasound: Ultrasound guided injection using GE Healthcare LOGIQ e Ultrasound
DASH - "Disabilities of the Arm, Shoulder, and Hand" Score At Baseline, and Change From Baseline at 6-8 Weeks, 12-16 Weeks, and at 1 Year Dash #1 Pre-Injection	39 score on a scale Interval 23.0 to 61.0	58 score on a scale Interval 25.0 to 90.0
DASH - "Disabilities of the Arm, Shoulder, and Hand" Score At Baseline, and Change From Baseline at 6-8 Weeks, 12-16 Weeks, and at 1 Year Dash #2 6-8 Weeks	11 score on a scale Interval 0.0 to 22.0	38 score on a scale Interval 3.0 to 91.0
DASH - "Disabilities of the Arm, Shoulder, and Hand" Score At Baseline, and Change From Baseline at 6-8 Weeks, 12-16 Weeks, and at 1 Year Dash #3 12-16 Weeks	30 score on a scale Interval 7.0 to 49.0	42 score on a scale Interval 6.0 to 71.0
DASH - "Disabilities of the Arm, Shoulder, and Hand" Score At Baseline, and Change From Baseline at 6-8 Weeks, 12-16 Weeks, and at 1 Year Dash #4 - 1 Year	9 score on a scale Interval 0.0 to 25.0	29 score on a scale Interval 0.0 to 91.0

Adverse Events

Unguided Injections

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ultrasound-guided Injections

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

Karen Gonzalez

Medical College of Wisconsin

Phone: 414-955-3221

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place