Trial Outcomes & Findings for Corticosteroid Injection for Common Upper Extremity Problems (NCT NCT00438672)

Results Overview

The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

64 participants

Primary outcome timeframe

6 months

Results posted on

2012-05-28

Participant Flow

Participant milestones

Participant milestones
Measure	Dexamethasone Cohort Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine	Placebo (Lidocaine Only) Cohort Single injection of 2 mL 1% lidocaine
Overall Study STARTED	31	33
Overall Study COMPLETED	24	24
Overall Study NOT COMPLETED	7	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Dexamethasone Cohort Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine	Placebo (Lidocaine Only) Cohort Single injection of 2 mL 1% lidocaine
Overall Study Lost to Follow-up	7	9

Baseline Characteristics

Corticosteroid Injection for Common Upper Extremity Problems

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexamethasone Cohort n=31 Participants Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine	Placebo (Lidocaine Only) Cohort n=33 Participants Single injection of 2 mL 1% lidocaine	Total n=64 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=99 Participants	31 Participants n=107 Participants	62 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	2 Participants n=107 Participants	2 Participants n=206 Participants
Age Continuous	48 years STANDARD_DEVIATION 8 • n=99 Participants	49 years STANDARD_DEVIATION 10 • n=107 Participants	49 years STANDARD_DEVIATION 9 • n=206 Participants
Sex: Female, Male Female	19 Participants n=99 Participants	18 Participants n=107 Participants	37 Participants n=206 Participants
Sex: Female, Male Male	12 Participants n=99 Participants	15 Participants n=107 Participants	27 Participants n=206 Participants
Region of Enrollment United States	31 participants n=99 Participants	33 participants n=107 Participants	64 participants n=206 Participants

PRIMARY outcome

Timeframe: 6 months

The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function.

Outcome measures

Outcome measures
Measure	Dexamethasone Cohort n=24 Participants Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine	Placebo (Lidocaine Only) Cohort n=24 Participants Single injection of 2 mL 1% lidocaine
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire	18 units on a scale Standard Deviation 20	13 units on a scale Standard Deviation 19

PRIMARY outcome

Timeframe: 6 months

Pain is measured on a 10 cm long line that starts at 0 on the left and ends with 10 on the right. A score of 0 represents no pain at all, and a score of 10 represents the worst pain ever. The individual score is measured using a measuring rod, measuring the distance from the left border in centimeters.

Outcome measures

Outcome measures
Measure	Dexamethasone Cohort n=24 Participants Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine	Placebo (Lidocaine Only) Cohort n=24 Participants Single injection of 2 mL 1% lidocaine
Visual Analog Scale for Pain	2.4 units on a scale Standard Deviation 2.9	1.7 units on a scale Standard Deviation 2.2

Adverse Events

Dexamethasone Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo (Lidocaine Only) Cohort

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. David Ring

Massachusetts General Hospital

Phone: 617-724-3953

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place