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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00438750
First received: February 20, 2007
Last updated: June 1, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention
Distal Radius Fractures
 Other: Independent Excercises
Other: Occupational Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Comparison of Occupational Therapy vs Home Exercises After Volar Plate Fixation of a Fracture of the Distal Radius

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Range of Motion in Degrees of the Wrists [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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.


  • 10-point Ordinal Pain Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    A ten point scale for pain at rest, with 0 as no pain and 10 as worst pain ever.

  • Pinch Strength [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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).


  • Gartland and Werley Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Mayo Wrist Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Grip Strength [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured with use of a grip meter as the average of three attempts.


Enrollment: 94
Study Start Date: January 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Independent Home Exercises
Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
 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.
Experimental: Formal Therapy
Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
 Other: 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438750

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: David Ring, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: David C. Ring, MD, Principal Investigator; Director of Research, Hand Service, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00438750     History of Changes
Other Study ID Numbers: 2006-P-001157
Study First Received: February 20, 2007
Results First Received: March 27, 2012
Last Updated: June 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
distal radius fracture
rehabilitation
volar plate fixation
DASH questionnaire

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries

ClinicalTrials.gov processed this record on May 16, 2013