Clinical trial NCT03498859: Efficacy of Physiotherapist-supervised Rehabilitation After Proximal Humerus Fracture
Official title: Efficacy of Physiotherapist-supervised Rehabilitation After Two-part Proximal Humerus Fractures Treated Non-operatively. A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proximal Humeral Fracture
Keywords: Rehabilitation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Tampere University Hospital
name: Oslo University Hospital
name: Regionshospitalet Viborg, Skive
First posted: 2018-04-17
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* Demented
* 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

Primary outcomes:
measure: The Disability of the Arm, Shoulder and Hand (DASH)
timeFrame: Measured at 3 months after fracture
Secondary outcomes:
measure: The Disability of the Arm, Shoulder and Hand (DASH)
timeFrame: Measured at baseline and after 12 months
measure: Constant Murley Shoulder Score
timeFrame: Measured after 3 and 12 months.
measure: 15-dimentional health-realted quality of life instrument (15D)
timeFrame: Measured at baseline, after 3 and 12 months
measure: Pain catastrophizing Scale
timeFrame: Measured at baseline, after 3 and 12 months
measure: Generel Self-Efficacy scale
timeFrame: Measured at baseline, after 3 and 12 months
measure: Accelerometer based activity in the upper extremity
timeFrame: Measured at 3 and 12 months
Other outcomes:
measure: Follow up of the decliners
timeFrame: Measured at baseline and 3 months
measure: Cost-effectiveness
timeFrame: After 12 months
Locations:
city: Viborg
country: Denmark
facility: Viborg Regional Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
citation: Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.