Efficacy of Physiotherapist-supervised Rehabilitation After Proximal Humerus Fracture

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Proximal Humeral Fracture

Intervention / Treatment
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* Other: Physiotherapist-supervised training
* Other: Home-based training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Home-based training<br>10 weeks of home-based training with no supervision of a physiotherapist | Other: Home-based training<br>* The intervention is home-based training during 10 weeks<br>|
| Other: Physiotherapist-supervised training<br>Physiotherapist-supervised training once per week during 10 weeks in addition to home-based training | Other: Physiotherapist-supervised training<br>* The intervention is physiotherapist-supervised training once per week during 10 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Disability of the Arm, Shoulder and Hand (DASH) | 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 | Measured at 3 months after fracture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Disability of the Arm, Shoulder and Hand (DASH) | 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 | Measured at baseline and after 12 months | 
| Constant Murley Shoulder Score | Subjective and objective measurement of the shoulder function. Measures on a 0-100 scale, where a lower score indicates greater disability. The scores will be compared between the 2 groups | Measured after 3 and 12 months. | 
| 15-dimentional health-realted quality of life instrument (15D) | Patient reported outcome measure of health related quality of life. A set of utility or preference weights is used to generate the 15D score (single index number) on a 0-1 scale, where a higher score indicates a poor health related quality of life. The scores will be compared between the 2 groups | Measured at baseline, after 3 and 12 months | 
| Pain catastrophizing Scale | Patient reported outcome measure. Measures on a 0-53 scale, where a higher score indicates a higher levels of pain catastrophizing thinking. The scores will be compared between the 2 groups. Also the correlation with DASH scores will be investigated | Measured at baseline, after 3 and 12 months | 
| Generel Self-Efficacy scale | Patient reported outcome measure. Measures on a 10-40 scale, where a higher score indicates a higher degree of self-efficacy. The scores will be compared between the 2 groups. Also the correlation with DASH scores will be investigated | Measured at baseline, after 3 and 12 months | 
| Accelerometer based activity in the upper extremity | The patient is wearing a censor above the elbow on both arms, that measures the level of upper extremity activity for three consecutive days. It measures the number of movements under and above shoulder hight and classify them into either high or low intensity movements. The asymmetry between the fractured and the healthy arm will be estimated and compared between the groups. | Measured at 3 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation