Post-traumatic Stiff Elbows
Conditions
Keywords
elbow, splint
Brief summary
Primary Question: When splinting is used to improve motion in post-traumatic stiff elbows, is there a significant difference in gains in motion achieved between static progressive or dynamic splint approaches? Secondary Question: Is there a significant difference in patient compliance with static progressive versus dynamic splint use, and does this effect final ulnohumeral motion outcomes?
Interventions
DEVICEStatic-Progressive Splint
Static progressive splinting is a well-established adjunct for restoring elbow motion. Such splints apply a static stress relaxation force to the elbow tissues, which is sequentially increased, as motion is achieved.
DEVICEDynamic Splint
Dynamic splints are a popular alternative, and apply a constant prolonged force to the tissues as additional motion is achieved.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All adult patients with post-traumatic elbow contractures in the Hand and Upper Extremity Service at Massachusetts General Hospital are eligible to for enrollment in this study regardless of sex, race or ethnicity.
Exclusion criteria
* Only English speaking patients will be eligible for the study since questionnaires have not been validated in other languages. * Vulnerable populations will not be recruited.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Arc of Flexion and Extension | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35 |
| 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. | 31 |
| Total | 66 |
Baseline characteristics
| Characteristic | Dynamic Splint | Static-progressive Splint | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 34 Participants | 64 Participants |
| Age Continuous | 45 years STANDARD_DEVIATION 12 | 43 years STANDARD_DEVIATION 13 | 44 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 31 participants | 35 participants | 66 participants |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 26 Participants |
| Sex: Female, Male Male | 18 Participants | 22 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 31 |
| serious Total, serious adverse events | 0 / 35 | 0 / 31 |
Outcome results
Primary
Change in Arc of Flexion and Extension
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.
Time frame: baseline and 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Static-progressive Splint | Change in Arc of Flexion and Extension | 39 Degrees |
| Dynamic Splint | Change in Arc of Flexion and Extension | 40 Degrees |
Secondary
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Static-progressive Splint | Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire | 26 units on a scale |
| Dynamic Splint | Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire | 28 units on a scale |