Clinical trial NCT00438750: Comparison of Occupational Therapy and Home Exercises for Adults With Operatively Treated Distal Radius Fractures
Official title: Prospective Randomized Comparison of Occupational Therapy vs Home Exercises After Volar Plate Fixation of a Fracture of the Distal Radius
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fractures
Keywords: distal radius fracture
rehabilitation
volar plate fixation
DASH questionnaire
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2007-02-22
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare to ways of rehabilitating after surgery for distal radius fractures treated operatively with a volar plate.

Detailed description: Operative treatment of distal radius fractures has become commonplace over the last three decades as our understanding of the relationship between the alignment of the distal radius and the function of the wrist and forearm has improved. Over the last 15 years there has been a trend towards more invasive, internal plate fixation of fractures of the distal radius. One argument in favor of internal fixation for these fractures is that it would be beneficial to allow early movement of the wrist articulation in an attempt to maximize final outcome. There is a difference in opinion among physicians on the importance of supervision of exercises in the recovery process. Some physicians advocate formal occupational therapy while other physicians believe that appropriate instructions for home exercises are just as good. A common belief is that the motivation of the patient plays an important part in recovery. In addition, Psychological and personality factors, such as pain anxiety, catastrophizing, and depression are strongly related to upper extremity specific health status and may also influence recovery. The goal of this study is to determine which protocol for exercises leads to better outcome in patients treated for distal radius with a volar plate. As a secondary goal and to generate hypotheses for later studies we would like to evaluate the influence of psychosocial factors on both objective (motion, grip strength) and subjective (DASH questionnaire) measures of functional recovery.

Eligibility criteria: Inclusion Criteria:

* Age 18 or greater.
* Isolated distal radial fracture.
* Fracture treated with volar plates, stable fixation.
* Initial treatment within 4 weeks of trauma.

Exclusion Criteria:

* Complex fractures that require additional or different material than volar plates.

Primary outcomes:
measure: Range of Motion in Degrees of the Wrists
timeFrame: 6 months
Secondary outcomes:
measure: Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
timeFrame: 6 months
measure: 10-point Ordinal Pain Scale
timeFrame: 6 months
measure: Pinch Strength
timeFrame: 6 months
measure: Gartland and Werley Score
timeFrame: 6 months
measure: Mayo Wrist Score
timeFrame: 6 months
measure: Grip Strength
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: David Ring, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: