Proximal Humeral FractureNCT03498859
Efficacy of Physiotherapist-supervised Rehabilitation After Proximal Humerus Fracture
A study testing Physiotherapist-supervised training and Home-based training in people with Proximal Humeral Fracture, run by University of Aarhus at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Proximal Humeral Fracture
- What is being tested?
- Physiotherapist-supervised training and Home-based training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Apr 2018to 25 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
Read the 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.
- Conditions
- Proximal Humeral Fracture
- Being tested
- Physiotherapist-supervised training, Home-based training
- Keywords
- Rehabilitation
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapist-supervised trainingOther
The intervention is physiotherapist-supervised training once per week during 10 weeks.
Home-based trainingOther
The intervention is home-based training during 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Home-based training | Other | 10 weeks of home-based training with no supervision of a physiotherapist Receives: Other: Home-based training |
| Physiotherapist-supervised training | Other | Physiotherapist-supervised training once per week during 10 weeks in addition to home-based training Receives: Other: Physiotherapist-supervised training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at 3 months after fracture
Secondary outcomes (6)
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: 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: 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: 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: 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: 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: Measured at 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start24 Apr 2018
- Primary completion25 Jan 2022
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Proximal Humeral FractureStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital, Oslo University Hospital, Regionshospitalet Viborg, Skive
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498859
- Sponsor's protocol ID
- ProxHumRehab
- Status last verified
- Dec 2022
- First submitted
- 3 Apr 2018
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35727196
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Physiotherapist-supervised Rehabilitation After Two-part Proximal Humerus Fractures Treated Non-operatively. A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03498859
- Acronym / sponsor ID
- ProxHumRehab
- Conditions
- Proximal Humeral Fracture
- Keywords
- Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Tampere University Hospital, Oslo University Hospital, Regionshospitalet Viborg, Skive
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based training | Other | Other: Home-based training10 weeks of home-based training with no supervision of a physiotherapist |
| Physiotherapist-supervised training | Other | Other: Physiotherapist-supervised trainingPhysiotherapist-supervised training once per week during 10 weeks in addition to home-based training |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- •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
Key exclusion criteria (15 listed)
- Refuse to participate in the study
- Younger than 60 years old
- Non-independent
- Demented
- Does no understand written and spoken guidance in local language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapist-supervised trainingThe intervention is physiotherapist-supervised training once per week during 10 weeks. | Other | Physiotherapist-supervised training |
| Home-based trainingThe intervention is home-based training during 10 weeks | Other | Home-based training |
Primary outcome
The Disability of the Arm, Shoulder and Hand (DASH)
Time frame: 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
6 secondary outcomes
The Disability of the Arm, Shoulder and Hand (DASH)
Time frame: Measured at baseline and after 12 months
Constant Murley Shoulder Score
Time frame: Measured after 3 and 12 months.
15-dimentional health-realted quality of life instrument (15D)
Time frame: Measured at baseline, after 3 and 12 months
Pain catastrophizing Scale
Time frame: Measured at baseline, after 3 and 12 months
Generel Self-Efficacy scale
Time frame: Measured at baseline, after 3 and 12 months
Accelerometer based activity in the upper extremity
Time frame: Measured at 3 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Derived from this study: PubMed 35727196Handoll 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapist-supervised training and Home-based training in people with Proximal Humeral Fracture, run by University of Aarhus at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Disability of the Arm, Shoulder and Hand (DASH) (time frame: Measured at 3 months after fracture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03498859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.