Shoulder FracturesNCT05302089
Rehabilitation Following Displaced Proximal Humerus Fractures
A study testing Pain management and shoulder bandage, One-time physiotherapy instruction and Usual rehabilitation care in people with Shoulder Fractures, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
Proximal humerus fractures (PHFs) are the third most common non-vertebral fractures in the elderly. Most elderly experience loss of function following a PHF regardless of treatment. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Shoulder Fractures
- What is being tested?
- Pain management and shoulder bandage, One-time physiotherapy instruction and Usual rehabilitation care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 5 May 2022to 20 Jan 2025
- 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
- Patients aged 60 years or above with displaced PHFs (Neer's definition) including 2-, 3-, or 4-part fractures after a low energy trauma will be recruited.
- Prior to first visit in the outpatient clinic all patients with PHFs will be screened for eligibility based on initial radiographs and medical records by an experienced orthopaedic consultant (senior author SB) at Zealand University Hospital, Køge, Denmark. The senior author classifies fracture categories.
- Patients should be cognitively capable of answering patient-reported outcome measures.
Who cannot join
- Dependent on daily personal care for basic activities of daily living
- Diagnosed with dementia or institutionalized
- Does not understand written and spoken guidance in Danish
- Pathological fracture or previous fracture in the same proximal humerus
- Concomitant injury or fracture.
- Polytrauma, high-energy trauma, or multiple fractures
Show all 11Show fewer
- Fracture dislocation or articular surface fracture
- Isolated tuberosity fracture
- Fractures not expected to heal by non-surgical treatment (no bony contact between head and shaft in both views)
- The senior author considers the patient unsuitable to attend the study for medical reasons (substance abuse, affective or psychotic disorders, apoplexy, chronic pain, malignant disease)
- Symptomatic glenohumeral osteoarthritis, rheumatoid arthritis, or rotator cuff-arthropathy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Orthopaedics, Zealand University Hospital
Køge, 4600
About this study
Official title: The Effect of Rehabilitation Following Non-surgical Management of Displaced Proximal Humerus Fractures: a Randomized Clinical Trial
Proximal humerus fractures (PHFs) are the third most common non-vertebral fractures in the elderly. Most elderly experience loss of function following a PHF regardless of treatment. A Cochrane review from 2015 concluded that surgical management is not superior to non-surgical management, and that the optimal non-surgical management after PHF is not known. Therefore, the aim of this study is to evaluate the effectiveness of usual rehabilitation care after displaced PHF compared with one-time physiotherapy instruction.
Read the detailed description
Proximal humerus fractures (PHFs) are the closely related to osteoporosis. The lifetime risk of suffering a PHF in females aged 50 or above is 13%. About half of the fractures are minimally displaced and usually managed by short immobilization, analgetics, and early mobilization. The remaining half of the patients suffer from displaced fractures, traditionally managed surgically by open reduction and internal fixation or shoulder replacement. Within the last decades, an increasing number of high-quality randomized controlled trials (RCTs) and meta-analyses have failed to document the superiority of surgical management in displaced PHFs. Therefore, an increasing number of patients are being offered nonsurgical treatment consisting of immobilization followed by rehabilitation that may vary across countries and regions. Most elderly experience loss of function following a PHF regardless of treatment. However, optimal management and recovery of function are paramount to prevent a substantial impact on the patient's independent living and morbidity. A systematic review and metaanalysis from 2021 concluded a need for high-quality RCTs to substantiate the current evidence regarding the need for supervision after a PHF.
It is assumed that rehabilitation delivered as structured training benefits patients with PHFs, but this is not known from current evidence. It is possible that patients are even harmed with intensive training programmes. Most RCTs with a non-surgically treated group use the same exercise intervention in the two groups to best identify the difference between surgery and non-surgical treatment. Therefore, the effect of training cannot be concluded from these studies. This is supported by an expectation of more nonsurgically treated displaced PHFs due to the growing evidence of no benefit from surgery. The current study is a prerequisite for future rehabilitation studies comparing different training modalities. Therefore, this study aims is to evaluate the effectiveness of usual rehabilitation care after displaced PHF compared with one-time physiotherapy instruction.
- Conditions
- Shoulder Fractures
- Being tested
- Pain management and shoulder bandage, One-time physiotherapy instruction, Usual rehabilitation care
- Keywords
- Proximal humerus fractures, Proximal humeral fractures, Randomized controlled trial, Shoulder fractures, Non-operative treatment, 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.
Pain management and shoulder bandageOther
All Patients receive standard pain management according to the local guidelines and a sling and swathe on the day of injury. After 10 to 14 days, all patients will receive a sling for optional use for one to two weeks and be randomized after oral and written informed consent.
One-time physiotherapy instructionOther
Patients are offered a one-time physiotherapy instruction about the course of pain and suggestions for quick and safe return to activities of daily living within the first three months post-injury.
Usual rehabilitation careOther
At the visit 10-14 days after the injury, the orthopaedic consultant (senior author SB) will refer the patient to usual rehabilitation care with a physiotherapist in a municipality close to the patient´s home. The physiotherapist then schedules the start date, typically three weeks after the injury. The rehabilitation content and duration is planned according to the choice of the local treating physiotherapist in consultation with the patient.
| Study group | Role | What they receive |
|---|---|---|
| One-time physiotherapy instruction | Experimental | One-time physiotherapy instruction and no usual rehabilitation care Receives: Other: Pain management and shoulder bandage; Other: One-time physiotherapy instruction |
| Usual rehabilitation care | Active comparator | One-time physiotherapy instruction and usual rehabilitation care Receives: Other: Pain management and shoulder bandage; Other: One-time physiotherapy instruction; Other: Usual rehabilitation care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Shoulder Score (OSS)
Patient administered shoulder specific score, score ranges between between 0 and 48, with a higher score implying a greater degree of disability.
Measured: 6 months
Secondary outcomes (4)
European Quality of life-5 Dimensions-Three-Level (EQ-5D-3L)
Health-related quality of life, index score: < 0 to 1 (full health), with anchoring of death as 0.
Measured: 6 months
European Quality of life-5 Dimensions-Three-Level (EQ-5D-3L)
Health-related quality of life, index score: < 0 to 1 (full health), with anchoring of death as 0.
Measured: 12 months
Conversion to surgery
Number of patients converting to surgery
Measured: 6 months
Oxford Shoulder Score (OSS)
Patient administered shoulder specific score, score ranges between between 0 and 48, with a higher score implying a greater degree of disability.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start5 May 2022
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
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 Shoulder FracturesStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, University of Copenhagen
- Responsible party
- Sponsor
- Investigators
- Behnam Liaghat, MSc, Principal investigator, Zealand University Hospital, University of Southern DenmarkStig Brorson, PhD, Study director, Zealand University Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302089
- Sponsor's protocol ID
- PHF_rehab
- Status last verified
- Jan 2025
- First submitted
- 14 Mar 2022
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised data on group level will be made available upon reasonable request after the primary publications have been published.
Publications
Liaghat B, Brorson S. Effect of structured rehabilitation versus non-structured rehabilitation following non-surgical management of displaced proximal humerus fractures: a protocol for a randomised clinical trial. BMJ Open. 2022 Oct 17;12(10):e064156. doi: 10.1136/bmjopen-2022-064156.
PubMed 36253041
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rehabilitation Following Non-surgical Management of Displaced Proximal Humerus Fractures: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05302089
- Acronym / sponsor ID
- PHF_rehab
- Conditions
- Shoulder Fractures
- Keywords
- Proximal humerus fractures, Proximal humeral fractures, Randomized controlled trial, Shoulder fractures, Non-operative treatment, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark, University of Copenhagen
- Study start
- 5 May 2022 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 31 Mar 2022 (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.
Proximal humerus fractures (PHFs) are the third most common non-vertebral fractures in the elderly. Most elderly experience loss of function following a PHF regardless of treatment. A Cochrane review from 2015 concluded that surgical management is not superior to non-surgical management, and that the optimal non-surgical management after PHF is not known. Therefore, the aim of this study is to evaluate the effectiveness of usual rehabilitation care after displaced PHF compared with one-time physiotherapy instruction.
Detailed description
Proximal humerus fractures (PHFs) are the closely related to osteoporosis. The lifetime risk of suffering a PHF in females aged 50 or above is 13%. About half of the fractures are minimally displaced and usually managed by short immobilization, analgetics, and early mobilization. The remaining half of the patients suffer from displaced fractures, traditionally managed surgically by open reduction and internal fixation or shoulder replacement. Within the last decades, an increasing number of high-quality randomized controlled trials (RCTs) and meta-analyses have failed to document the superiority of surgical management in displaced PHFs. Therefore, an increasing number of patients are being offered nonsurgical treatment consisting of immobilization followed by rehabilitation that may vary across countries and regions. Most elderly experience loss of function following a PHF regardless of treatment. However, optimal management and recovery of function are paramount to prevent a substantial impact on the patient's independent living and morbidity. A systematic review and metaanalysis from 2021 concluded a need for high-quality RCTs to substantiate the current evidence regarding the need for supervision after a PHF.
It is assumed that rehabilitation delivered as structured training benefits patients with PHFs, but this is not known from current evidence. It is possible that patients are even harmed with intensive training programmes. Most RCTs with a non-surgically treated group use the same exercise intervention in the two groups to best identify the difference between surgery and non-surgical treatment. Therefore, the effect of training cannot be concluded from these studies. This is supported by an expectation of more nonsurgically treated displaced PHFs due to the growing evidence of no benefit from surgery. The current study is a prerequisite for future rehabilitation studies comparing different training modalities. Therefore, this study aims is to evaluate the effectiveness of usual rehabilitation care after displaced PHF compared with one-time physiotherapy instruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-time physiotherapy instruction | Experimental | Other: Pain management and shoulder bandage, Other: One-time physiotherapy instructionOne-time physiotherapy instruction and no usual rehabilitation care |
| Usual rehabilitation care | Active comparator | Other: Pain management and shoulder bandage, Other: One-time physiotherapy instruction, Other: Usual rehabilitation careOne-time physiotherapy instruction and usual rehabilitation care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 60 years or above with displaced PHFs (Neer's definition) including 2-, 3-, or 4-part fractures after a low energy trauma will be recruited.
- Prior to first visit in the outpatient clinic all patients with PHFs will be screened for eligibility based on initial radiographs and medical records by an experienced orthopaedic consultant (senior author SB) at Zealand University Hospital, Køge, Denmark. The senior author classifies fracture categories.
- Patients should be cognitively capable of answering patient-reported outcome measures.
Key exclusion criteria (11 listed)
- Dependent on daily personal care for basic activities of daily living
- Diagnosed with dementia or institutionalized
- Does not understand written and spoken guidance in Danish
- Pathological fracture or previous fracture in the same proximal humerus
- Concomitant injury or fracture.
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 |
|---|---|---|
| Pain management and shoulder bandageAll Patients receive standard pain management according to the local guidelines and a sling and swathe on the day of injury. After 10 to 14 days, all patients will receive a sling for optional use for one to two weeks and be randomized after oral and written informed consent. | Other | One-time physiotherapy instruction, Usual rehabilitation care |
| One-time physiotherapy instructionPatients are offered a one-time physiotherapy instruction about the course of pain and suggestions for quick and safe return to activities of daily living within the first three months post-injury. | Other | One-time physiotherapy instruction, Usual rehabilitation care |
| Usual rehabilitation careAt the visit 10-14 days after the injury, the orthopaedic consultant (senior author SB) will refer the patient to usual rehabilitation care with a physiotherapist in a municipality close to the patient´s home. The physiotherapist then schedules the start date, typically three weeks after the injury. The rehabilitation content and duration is planned according to the choice of the local treating physiotherapist in consultation with the patient. | Other | Usual rehabilitation care |
Primary outcome
Oxford Shoulder Score (OSS)
Time frame: 6 months
Patient administered shoulder specific score, score ranges between between 0 and 48, with a higher score implying a greater degree of disability.
4 secondary outcomes
European Quality of life-5 Dimensions-Three-Level (EQ-5D-3L)
Time frame: 6 months
European Quality of life-5 Dimensions-Three-Level (EQ-5D-3L)
Time frame: 12 months
Conversion to surgery
Time frame: 6 months
Oxford Shoulder Score (OSS)
Time frame: 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 11 Feb 2025.
- Derived from this study: PubMed 36253041Liaghat B, Brorson S. Effect of structured rehabilitation versus non-structured rehabilitation following non-surgical management of displaced proximal humerus fractures: a protocol for a randomised clinical trial. BMJ Open. 2022 Oct 17;12(10):e064156. doi: 10.1136/bmjopen-2022-064156.
- Individual participant dataSharing planned: No. Anonymised data on group level will be made available upon reasonable request after the primary publications have been published.
Related trials for Shoulder Fractures
RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruitingObservational study
Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
Anterior Shoulder Instability
Not yet recruiting
Study on Outcomes of Proximal Humerus Fractures
Proximal Humerus Fracture
Recruiting
Comparison of Surgical Techniques for Anterior Shoulder Instability
Surgeons, Shoulder Instability
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.
Behnam Liaghat, MSc principal investigator
Zealand University Hospital, University of Southern Denmark
Stig Brorson, PhD study director
Zealand University Hospital, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain management and shoulder bandage, One-time physiotherapy instruction and Usual rehabilitation care in people with Shoulder Fractures, run by Zealand University Hospital at 1 site in Denmark.
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 3 inclusion and 11 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 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Oxford Shoulder Score (OSS) (time frame: 6 months). 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 NCT05302089, 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 11 Feb 2025.