Comparison of Occupational Therapy and Home Exercises for Adults With Operatively Treated Distal Radius Fractures

Distal Radius Fractures Clinical Trial

Official title:

Prospective Randomized Comparison of Occupational Therapy vs Home Exercises After Volar Plate Fixation of a Fracture of the Distal Radius

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00438750
• Other study ID #: 2006-P-001157
• Status: Completed
• Phase: N/A
• First received: February 20, 2007
• Last updated: June 1, 2012
• Start date: January 2007
• Est. completion date: May 2010

Study information

• Verified date: June 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Distal Radius Fractures
• Fractures, Bone
• Radius Fractures

Intervention

Other:
• Independent Excercises
Subjects provided with wrist splint and instructions for independent exercises to perform at home on their own. Subjects were advised to perform exercises as often as possible, but at least three to four times a day for a minimum of thirty minutes. There was no formal strengthening program.
• Occupational Therapy
Subjects were prescribed formal occupational therapy with supervised exercises to regain digit, wrist, and forearm motion and to strengthen the hand. The content, frequency, and duration of the rehabilitation program were at the discretion of the treating hand therapist.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of Motion in Degrees of the Wrists	Mean arc of wrist flexion and extension six months after surgery.; Normal/expected range of motion for arc of wrist flexion and extension is approximately 160 degrees.	6 months	No
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.; Mean and standard deviations are identical for both arms.	6 months	No
Secondary	10-point Ordinal Pain Scale	A ten point scale for pain at rest, with 0 as no pain and 10 as worst pain ever.	6 months	No
Secondary	Pinch Strength	Pinch strength measured with the B&L pinch gauge.; B&L Engineering is the official name of the company (nowhere is there an expansion of this acronym).	6 months	No
Secondary	Gartland and Werley Score	An objective evaluation of wrist function with 0 to 2 as excellent, 3-8 as good, 9-20 as fair, and 21 and above as poor range of motion.	6 months	No
Secondary	Mayo Wrist Score	A composite score based on pain intensity, range of motion, grip strength, and functional status. The scale is as follows: below 60 is poor, 60-80 is satisfactory, 80-90 is good, and 90-100 is excellent.	6 months	No
Secondary	Grip Strength	Measured with use of a grip meter as the average of three attempts.	6 months	No