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Efficacy of Physiotherapist-supervised Rehabilitation After Proximal Humerus Fracture

Primary Purpose

Proximal Humeral Fracture

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Physiotherapist-supervised training
Home-based training
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proximal Humeral Fracture focused on measuring Rehabilitation

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Viborg Regional Hospital
  • Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Home-based training

Physiotherapist-supervised training

Arm Description

10 weeks of home-based training with no supervision of a physiotherapist

Physiotherapist-supervised training once per week during 10 weeks in addition to home-based training

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
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.

Full Information

First Posted
April 3, 2018
Last Updated
January 4, 2023
Sponsor
University of Aarhus
Collaborators
Tampere University Hospital, Oslo University Hospital, Regionshospitalet Viborg, Skive
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1. Study Identification

Unique Protocol Identification Number
NCT03498859
Brief Title
Efficacy of Physiotherapist-supervised Rehabilitation After Proximal Humerus Fracture
Official Title
Efficacy of Physiotherapist-supervised Rehabilitation After Two-part Proximal Humerus Fractures Treated Non-operatively. A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 24, 2018 (Actual)
Primary Completion Date
January 25, 2022 (Actual)
Study Completion Date
January 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Tampere University Hospital, Oslo University Hospital, Regionshospitalet Viborg, Skive

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proximal Humeral Fracture
Keywords
Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home-based training
Arm Type
Other
Arm Description
10 weeks of home-based training with no supervision of a physiotherapist
Arm Title
Physiotherapist-supervised training
Arm Type
Other
Arm Description
Physiotherapist-supervised training once per week during 10 weeks in addition to home-based training
Intervention Type
Other
Intervention Name(s)
Physiotherapist-supervised training
Intervention Description
The intervention is physiotherapist-supervised training once per week during 10 weeks.
Intervention Type
Other
Intervention Name(s)
Home-based training
Intervention Description
The intervention is home-based training during 10 weeks
Primary Outcome Measure Information:
Title
The Disability of the Arm, Shoulder and Hand (DASH)
Description
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
Time Frame
Measured at 3 months after fracture
Secondary Outcome Measure Information:
Title
The Disability of the Arm, Shoulder and Hand (DASH)
Description
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
Time Frame
Measured at baseline and after 12 months
Title
Constant Murley Shoulder Score
Description
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
Time Frame
Measured after 3 and 12 months.
Title
15-dimentional health-realted quality of life instrument (15D)
Description
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
Time Frame
Measured at baseline, after 3 and 12 months
Title
Pain catastrophizing Scale
Description
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
Time Frame
Measured at baseline, after 3 and 12 months
Title
Generel Self-Efficacy scale
Description
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
Time Frame
Measured at baseline, after 3 and 12 months
Title
Accelerometer based activity in the upper extremity
Description
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.
Time Frame
Measured at 3 and 12 months
Other Pre-specified Outcome Measures:
Title
Follow up of the decliners
Description
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
Time Frame
Measured at baseline and 3 months
Title
Cost-effectiveness
Description
A cost-effectiveness analysis (QALY) of the two training modalities will be performed and a ratio will be estimated.
Time Frame
After 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Viborg Regional Hospital
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
35727196
Citation
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.
Results Reference
derived

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Efficacy of Physiotherapist-supervised Rehabilitation After Proximal Humerus Fracture

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