Trial Outcomes & Findings for A Prospective Randomized Trial of Static-Progressive Versus Dynamic Splinting for Post-Traumatic Elbow Stiffness (NCT NCT01241916)

NCT ID: NCT01241916

Last Updated: 2012-07-03

Results Overview

Active ulnohumeral motion will be measured using a hand-held goniometer by the co-investigator not involved in the care of the patient at enrollment and 6 months after enrollment.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 66 participants
• Primary outcome timeframe: baseline and 6 months
• Results posted on: 2012-07-03

Participant Flow

Participant milestones

Measure	Static-progressive Splint Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.	Dynamic Splint Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
Overall Study STARTED	35	31
Overall Study COMPLETED	28	21
Overall Study NOT COMPLETED	7	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Prospective Randomized Trial of Static-Progressive Versus Dynamic Splinting for Post-Traumatic Elbow Stiffness

Baseline characteristics by cohort

Measure	Static-progressive Splint n=35 Participants Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.	Dynamic Splint n=31 Participants Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.	Total n=66 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	30 Participants n=7 Participants	64 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age Continuous	43 years STANDARD_DEVIATION 13 • n=5 Participants	45 years STANDARD_DEVIATION 12 • n=7 Participants	44 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	31 participants n=7 Participants	66 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6 months

Active ulnohumeral motion will be measured using a hand-held goniometer by the co-investigator not involved in the care of the patient at enrollment and 6 months after enrollment.

Outcome measures

Measure	Static-progressive Splint n=28 Participants Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.	Dynamic Splint n=24 Participants Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
Change in Arc of Flexion and Extension	39 Degrees Interval -10.0 to 85.0	40 Degrees Interval -15.0 to 70.0

SECONDARY outcome

Timeframe: 12 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

Measure	Static-progressive Splint n=28 Participants Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.	Dynamic Splint n=21 Participants Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire	26 units on a scale Interval 2.0 to 77.0	28 units on a scale Interval 3.0 to 76.0

Adverse Events

Static-progressive Splint

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dynamic Splint

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: dring@partners.org

Results disclosure agreements

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