Efficacy of Physiotherapist-supervised Rehabilitation After Proximal Humerus Fracture

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

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.

Study Overview

• Status: Completed
• Conditions: Proximal Humeral Fracture
• Intervention / Treatment: Other: Home-based training; Other: Physiotherapist-supervised training

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Viborg, Denmark, 8800
    • Viborg Regional Hospital
• Norway
  • Oslo, Norway
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Cost-effectiveness	A cost-effectiveness analysis (QALY) of the two training modalities will be performed and a ratio will be estimated.	After 12 months

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Oslo University Hospital; Tampere University Hospital; Regionshospitalet Viborg, Skive

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2018
• Primary Completion (Actual): January 25, 2022
• Study Completion (Actual): January 25, 2022

Study Registration Dates

• First Submitted: April 3, 2018
• First Submitted That Met QC Criteria: April 13, 2018
• First Posted (Actual): April 17, 2018

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation
• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: ProxHumRehab

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No