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Comparison of Early and Late Therapy for Adults With Non-Operatively Treated Proximal Humerus Fractures

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00438633
First received: February 20, 2007
Last updated: July 20, 2012
Last verified: July 2012
History of Changes
  Purpose

The purpose of the study is to compare two common ways of rehabilitating after proximal humerus fractures treated non-operatively.


Condition
Proximal Humeral Fractures

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early vs Delayed Physical Therapy (Exercises) for Non-Operatively-Treated Proximal Humerus Fractures: A Prospective Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • shoulder flexion [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • shoulder pain Likert scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • external and internal rotation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • abduction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • DASH and Constant scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 60
Study Start Date: February 2005
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Subjects who begin therapy immediately after diagnosis of injury.
2
Subjects who delay therapy for 3 weeks after diagnosis of injury.

Detailed Description:

Proximal humerus fractures with limited displacement and fractures that occur in older, less active or infirm patients are treated non-operatively. There is a general impression, supported by some data, that better function is obtained with immediate initiation of shoulder exercises. However, there is some concern that this may contribute to nonunion of the fracture and may be unnecessary. Some researchers have demonstrated better outcomes with immediate rehabilitation with pendulum movements. Others have shown similar functional outcomes when rehabilitation begins approximately a month after injury, or when radiographs show signs of bone healing, and this delay is associated with lower rates of non-union and malunion occurrence.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients from the MGH Hand and Upper Extremity or Trauma service

Criteria

Inclusion Criteria:

  • Male and Female patients.
  • Any race
  • Older than 18y
  • Diagnosed with proximal humeral fracture clinically and confirmed by imaging studies: X rays and/or CT Scans.
  • Any type of proximal humeral fracture according to the Neer or AO classification system.
  • Patient should have received non-operative treatment.

Exclusion Criteria:

  • Patients younger than 18 y.
  • Patients with multiple other fractures.
  • Patients that have received surgical treatment including closed reduction and percutaneous fixation, open reduction and internal fixation (plates, screws, pins, tension wire bands, cerclage wiring and/or intramedullary nailing) and/or articular shoulder prosthesis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438633

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: NCT00438633     History of Changes
Other Study ID Numbers: 2004-P-002235
Study First Received: February 20, 2007
Last Updated: July 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
proximal humerus fracture
rehabilitation
non-operative treatment
DASH and Constant instruments

Additional relevant MeSH terms:
Humeral Fractures
Shoulder Fractures
Arm Injuries
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on March 03, 2015