Efficacy of Physiotherapist-supervised Rehabilitation After Proximal Humerus Fracture

Not Applicable

Completed

• Conditions: Proximal Humeral Fracture
• Interventions: Other: Home-based training; Other: Physiotherapist-supervised training

• Registration Number: NCT03498859
• Lead Sponsor: University of Aarhus

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 Timeline

• Study First Submitted: 2018-04-03
• Study First Submitted QC: 2018-04-13
• Study First Posted: 2018-04-17
• Study Start: 2018-04-24
• Primary Completion: 2022-01-25
• Study Completion: 2022-01-25
• Status Verified: 2022-12
• Last Update Submitted: 2023-01-04
• Last Update Posted: 2023-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home-based training	Home-based training	10 weeks of home-based training with no supervision of a physiotherapist
Physiotherapist-supervised training	Physiotherapist-supervised training	Physiotherapist-supervised training once per week during 10 weeks in addition to home-based training

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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.

Trial Locations

Locations (2)

Oslo University Hospital; 🇳🇴 Oslo, Norway

Viborg Regional Hospital; 🇩🇰 Viborg, Denmark