Proximal Humeral Fracture
Conditions
Keywords
Rehabilitation
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.
Interventions
OTHERPhysiotherapist-supervised training
The intervention is physiotherapist-supervised training once per week during 10 weeks.
OTHERHome-based training
The intervention is home-based training during 10 weeks
Sponsors
Tampere University Hospital
Oslo University Hospital
Regionshospitalet Viborg, Skive
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Disability of the Arm, Shoulder and Hand (DASH) | 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
| Measure | Time frame | Description |
|---|---|---|
| The Disability of the Arm, Shoulder and Hand (DASH) | Measured at baseline and after 12 months | 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 |
| Constant Murley Shoulder Score | Measured after 3 and 12 months. | 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 |
| 15-dimentional health-realted quality of life instrument (15D) | Measured at baseline, after 3 and 12 months | 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 |
| Generel Self-Efficacy scale | Measured at baseline, after 3 and 12 months | 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 |
| Accelerometer based activity in the upper extremity | Measured at 3 and 12 months | 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. |
| Pain catastrophizing Scale | Measured at baseline, after 3 and 12 months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Follow up of the decliners | Measured at baseline and 3 months | Patients declining to participate in the randomised trial will be invited to follow up visits, consisting of x-rays and identical questionnaires as used in the RCT |
| Cost-effectiveness | After 12 months | A cost-effectiveness analysis (QALY) of the two training modalities will be performed and a ratio will be estimated. |
Countries
Denmark, Norway
Outcome results
None listed