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Clinical Trials/NCT03498859
NCT03498859
Completed
Not Applicable

Efficacy of Physiotherapist-supervised Rehabilitation After Two-part Proximal Humerus Fractures Treated Non-operatively. A Randomised Controlled Trial

University of Aarhus2 sites in 2 countries70 target enrollmentApril 24, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Proximal Humeral Fracture
Sponsor
University of Aarhus
Enrollment
70
Locations
2
Primary Endpoint
The Disability of the Arm, Shoulder and Hand (DASH)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This study investigates the efficacy of physiotherapist-supervised training once per week during 10 weeks compared to home-based training during 10 weeks, after proksimal humerus fracture.

Detailed Description

Proximal humerus fracture is the third most common fracture in elderly people after hip and colles fracture, and are often caused by fall and osteoporosis. These fractures are highly related to morbidity and mortality among elderly people and consumes considerably health care resources. More than 70% of the proximal humerus fracture patients are over 60 years of age and 75% are female. Only sparse evidence reveals to what extend the patients need rehabilitation and how it should be implemented in the treatment strategy. In Denmark as well as in Finland the rehabilitation after proximal humerus fractures takes place in local centers in the municipalities, and the rehabilitation offered to the patients varies significantly. Currently in Denmark there are no national clinical guidelines to support the rehabilitation strategy.

Registry
clinicaltrials.gov
Start Date
April 24, 2018
End Date
January 25, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Low energy proximal humeral displaced (more than 5mm or 30 degrees) two-part fracture where fracture line emerges through the surgical (or anatomical) neck, treated non-operatively

Exclusion Criteria

  • Refuse to participate in the study
  • Younger than 60 years old
  • Non-independent
  • Does no understand written and spoken guidance in local language
  • Pathological fracture or previous fracture in the same proximal humerus
  • Other operational injuries in the same upper limb
  • Major nerve injury (e.g. Complete radialis- or delta palsy)
  • Open fracture
  • Multi-trauma patient
  • Fracture dislocation or head splitting fracture

Outcomes

Primary Outcomes

The Disability of the Arm, Shoulder and Hand (DASH)

Time Frame: Measured at 3 months after fracture

Patient reported outcome measure of physical function in the upper extremity. Measures on a 0-100 scale, where a higher score indicates greater disability. The scores will be compared between the 2 groups

Secondary Outcomes

  • Constant Murley Shoulder Score(Measured after 3 and 12 months.)
  • Pain catastrophizing Scale(Measured at baseline, after 3 and 12 months)
  • The Disability of the Arm, Shoulder and Hand (DASH)(Measured at baseline and after 12 months)
  • 15-dimentional health-realted quality of life instrument (15D)(Measured at baseline, after 3 and 12 months)
  • Generel Self-Efficacy scale(Measured at baseline, after 3 and 12 months)
  • Accelerometer based activity in the upper extremity(Measured at 3 and 12 months)

Study Sites (2)

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