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

NCT ID: NCT01241916

Last Updated: 2012-07-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2010-09-30

Brief Summary

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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?"

Detailed Description

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Conditions

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Post-traumatic Stiff Elbows

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Static-progressive splint

Group Type EXPERIMENTAL

Static-Progressive Splint

Intervention Type 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

Group Type EXPERIMENTAL

Dynamic Splint

Intervention Type DEVICE

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

Interventions

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Static-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.

Intervention Type DEVICE

Dynamic Splint

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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David C. Ring, MD

Director of Research, Hand Service

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2003P001441

Identifier Type: -

Identifier Source: org_study_id

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