Efficacy of Physiotherapist-supervised Rehabilitation After Two-part Proximal Humerus Fractures Treated Non-operatively. A Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- The Disability of the Arm, Shoulder and Hand (DASH)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Undisplaced fracture
- •Isolated tuberculum fracture
- •Fracture has no precondition to ossify by conservative treatment (no bony contact between fracture parts or the humeral shaft is in contact with the articular surface)
- •Treating surgeon considers patient unsuitable to attend the study on medical basis
Arms & Interventions
Home-based training
10 weeks of home-based training with no supervision of a physiotherapist
Intervention: Home-based training (Other)
Physiotherapist-supervised training
Physiotherapist-supervised training once per week during 10 weeks in addition to home-based training
Intervention: Physiotherapist-supervised training (Other)
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)