Efficacy of Physiotherapist-supervised Rehabilitation After Proximal Humerus Fracture

Proximal Humeral Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03498859
• Other study ID #: ProxHumRehab
• Status: Completed
• Phase: N/A
• Start date: April 24, 2018
• Est. completion date: January 25, 2022

Study information

• Verified date: December 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 25, 2022
• Est. primary completion date: January 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Proximal Humeral Fracture
• Shoulder Fractures

Intervention

Other:
• Physiotherapist-supervised training
The intervention is physiotherapist-supervised training once per week during 10 weeks.
• Home-based training
The intervention is home-based training during 10 weeks

Locations

Country	Name	City	State
Denmark	Viborg Regional Hospital	Viborg
Norway	Oslo University Hospital	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Oslo University Hospital, Regionshospitalet Viborg, Skive, Tampere University Hospital

Countries where clinical trial is conducted

Denmark,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Follow up of the decliners	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	Measured at baseline and 3 months
Other	Cost-effectiveness	A cost-effectiveness analysis (QALY) of the two training modalities will be performed and a ratio will be estimated.	After 12 months
Primary	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	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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