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OpenTrials
Completed

NCT Number: NCT01241916

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

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?"

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Key information

Conditions

Post-traumatic Stiff Elbows

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Static-Progressive Splint

Device

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.

Dynamic Splint

Device

Dynamic splints are a popular alternative, and apply a constant prolonged force to the tissues as additional motion is achieved.

Primary outcomes

  1. Change in Arc of Flexion and Extension

    Time frame: 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 outcomes

  1. Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2003
Primary completion
2009
Study completion
2010
First posted
Nov 16, 2010
Registry last updated
Jul 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.