Humeral FractureEarly Phase 1NCT02467803
Shoulder Functional Outcomes of Patients With Proximal Humerus Fractures: Comparison of Two Different Treatment Protocol
A Early Phase 1 study testing Scapula mobilization and Shoulder ROM exercises in people with Humeral Fracture, run by Hacettepe University.
Trial summary
Fractures of the proximal humerus and the humeral head are most common injuries and the management is challenging. Functional therapy with short immobilization, followed by an accelerated physiotherapy protocol, is a simple, convenient, noninvasive, and efficient management option. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Humeral Fracture
- What is being tested?
- Scapula mobilization and Shoulder ROM exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jan 2016
- Phase
- Early Phase 1
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be recruited if they have radiologically proven, closed fracture of the humerus according to American Orthopedics and Neer classification.
Who cannot join
- skeletally immature patients
- patients presenting to the hospital 10 days or more after injury
- patients with open fractures or multiple trauma
- pre-existing illness affecting the function of the upper limb, such as multiple sclerosis, paraplegia, and others
- patients with a history of drug or alcohol abuse
- patients with cooperation problems or problems in attending all scheduled study visits.
Trial locations and contacts
No sites are listed yet.
Hande Guney, PhD contact
About this study
Fractures of the proximal humerus and the humeral head are most common injuries and the management is challenging. Functional therapy with short immobilization, followed by an accelerated physiotherapy protocol, is a simple, convenient, noninvasive, and efficient management option. This prospective randomized study is aim to assess the function of the upper extremity of patients who will be assigned to nonoperative treatment of a proximal humeral fracture. The primary objective is the Constant score. Secondary objectives are the Disabilities of the Arm, Shoulder, and Hand (DASH) instrument, measurement of shoulder range of motion (ROM), pain and depression level with Beck Depression Scale.
Read the detailed description
In this prospective randomized controlled trial, informed consent forms were obtained from all participants and they were informed about the study based on the Declaration of Helsinki. The study was approved by local ethics committee of Hacettepe University (GO13/55). After comprehensive clinical evaluation, subjects were randomly assigned to the intervention group or the control group, using Random Allocation Software. The intervention group received scapular mobilization with upper extremity ROM exercises, the control group received only shoulder ROM exercises.
Patients with a radiographically proven, closed fracture of the proximal humerus admitted to the emergency department of Hacettepe University Hospital, who were considered suitable for primary nonoperative management by the orthopedic surgeon on charge, were asked to participate in this investigation.
The exclusion criteria are (1) skeletally immature patients (2) patients presenting to the hospital 10 days or more after injury (3) patients with open fractures or multiple trauma (4) pre-existing illness affecting the function of the upper limb, such as multiple sclerosis, paraplegia, and others (5) patients with a history of drug or alcohol abuse (6) patients with cooperation problems or problems in attending all scheduled study visits.
Patients' demographics (ie, gender, age, profession, smoking, concomitant diseases, medication) and injury characteristics (ie, accident type, energy level of trauma, concomitant injuries, fracture classification) will be recorded. Patients will be asked to rate their upper limb function 1 week before the accident to determine their baseline DASH score using the extended 3-modular questionnaire.13 Normalized DASH scores range from 0 (perfect function) to 100 (functionless extremity/joint).
Radiographs will be obtained in anterior-posterior projection and Neer's view upon admission in the emergency department and after manipulation. Additional computed tomography (CT) scans will be ordered at the discretion of the treating surgeon. Fractures were classified according to the American Orthopedics and Neer scheme by the orthopedic surgeon.
The intervention group will receive scapular mobilization after the sling will be removed. Scapular mobilization will be applied 3 times a week, a total of 24 sessions for 8 weeks. Each session lasted around 15-20 minutes. The shoulder flexion and abduction ROM exercises will be showed to the patients and performed 3 times, 10 sets on each day after the sling will be removed.
The control group will only perform the shoulder ROM exercises. Patients will be monitored and physically examined on the day sling removed (approximately 4 week after injury), 3 and 6 months after injury. Primary outcome measures comprised raw Constant scores and differences to the contralateral, healthy shoulder. The Constant score will show the change from baseline in shoulder functional outcomes at 6 months after injury) Pain levels will be measured on a 0-10 cm (0=no pain, 10=severe pain) visual analogue scale (VAS). The Constant score, DASH, pain level, shoulder ROM and Beck Depression Scale will be recorded on the day sling removed and 6 months after injury. Plain radiographs of the injured shoulder in 2 planes were obtained to determine fracture healing.
- Conditions
- Humeral Fracture
- Being tested
- Scapula mobilization, Shoulder ROM exercises
- Keywords
- humeral fracture, exercise, musculoskeletal manipulations
- Medical subject headings
- Humeral Fractures, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scapula mobilizationOther
Shoulder ROM exercisesOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | We applied scapula mobilization with shoulder ROM exercises Receives: Other: Scapula mobilization; Other: Shoulder ROM exercises |
| Control | Other | We applied only shoulder ROM exercises Receives: Other: Shoulder ROM exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant Score
Measured: Patients will be followed for 6 months. The differences between baseline score and at the end of 6 months score will be assessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2016 (estimated)
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 Humeral FractureStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HANDE GUNEY, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467803
- Sponsor's protocol ID
- GO13/55
- Status last verified
- May 2015
- First submitted
- 26 May 2015
- Last updated
- 10 Jun 2015
- Results posted
- 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 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shoulder Functional Outcomes of Patients With Proximal Humerus Fractures: Comparison of Two Different Treatment Protocol
- ClinicalTrials.gov ID
- NCT02467803
- Acronym / sponsor ID
- GO13/55
- Conditions
- Humeral Fracture
- Keywords
- humeral fracture, exercise, musculoskeletal manipulations
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jan 2016 (estimated)
- First posted
- 10 Jun 2015 (estimated)
- 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.
Fractures of the proximal humerus and the humeral head are most common injuries and the management is challenging. Functional therapy with short immobilization, followed by an accelerated physiotherapy protocol, is a simple, convenient, noninvasive, and efficient management option. This prospective randomized study is aim to assess the function of the upper extremity of patients who will be assigned to nonoperative treatment of a proximal humeral fracture. The primary objective is the Constant score. Secondary objectives are the Disabilities of the Arm, Shoulder, and Hand (DASH) instrument, measurement of shoulder range of motion (ROM), pain and depression level with Beck Depression Scale.
Detailed description
In this prospective randomized controlled trial, informed consent forms were obtained from all participants and they were informed about the study based on the Declaration of Helsinki. The study was approved by local ethics committee of Hacettepe University (GO13/55). After comprehensive clinical evaluation, subjects were randomly assigned to the intervention group or the control group, using Random Allocation Software. The intervention group received scapular mobilization with upper extremity ROM exercises, the control group received only shoulder ROM exercises.
Patients with a radiographically proven, closed fracture of the proximal humerus admitted to the emergency department of Hacettepe University Hospital, who were considered suitable for primary nonoperative management by the orthopedic surgeon on charge, were asked to participate in this investigation.
The exclusion criteria are (1) skeletally immature patients (2) patients presenting to the hospital 10 days or more after injury (3) patients with open fractures or multiple trauma (4) pre-existing illness affecting the function of the upper limb, such as multiple sclerosis, paraplegia, and others (5) patients with a history of drug or alcohol abuse (6) patients with cooperation problems or problems in attending all scheduled study visits.
Patients' demographics (ie, gender, age, profession, smoking, concomitant diseases, medication) and injury characteristics (ie, accident type, energy level of trauma, concomitant injuries, fracture classification) will be recorded. Patients will be asked to rate their upper limb function 1 week before the accident to determine their baseline DASH score using the extended 3-modular questionnaire.13 Normalized DASH scores range from 0 (perfect function) to 100 (functionless extremity/joint).
Radiographs will be obtained in anterior-posterior projection and Neer's view upon admission in the emergency department and after manipulation. Additional computed tomography (CT) scans will be ordered at the discretion of the treating surgeon. Fractures were classified according to the American Orthopedics and Neer scheme by the orthopedic surgeon.
The intervention group will receive scapular mobilization after the sling will be removed. Scapular mobilization will be applied 3 times a week, a total of 24 sessions for 8 weeks. Each session lasted around 15-20 minutes. The shoulder flexion and abduction ROM exercises will be showed to the patients and performed 3 times, 10 sets on each day after the sling will be removed.
The control group will only perform the shoulder ROM exercises. Patients will be monitored and physically examined on the day sling removed (approximately 4 week after injury), 3 and 6 months after injury. Primary outcome measures comprised raw Constant scores and differences to the contralateral, healthy shoulder. The Constant score will show the change from baseline in shoulder functional outcomes at 6 months after injury) Pain levels will be measured on a 0-10 cm (0=no pain, 10=severe pain) visual analogue scale (VAS). The Constant score, DASH, pain level, shoulder ROM and Beck Depression Scale will be recorded on the day sling removed and 6 months after injury. Plain radiographs of the injured shoulder in 2 planes were obtained to determine fracture healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Scapula mobilization, Other: Shoulder ROM exercisesWe applied scapula mobilization with shoulder ROM exercises |
| Control | Other | Other: Shoulder ROM exercisesWe applied only shoulder ROM exercises |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients will be recruited if they have radiologically proven, closed fracture of the humerus according to American Orthopedics and Neer classification.
Key exclusion criteria (6 listed)
- skeletally immature patients
- patients presenting to the hospital 10 days or more after injury
- patients with open fractures or multiple trauma
- pre-existing illness affecting the function of the upper limb, such as multiple sclerosis, paraplegia, and others
- patients with a history of drug or alcohol abuse
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 |
|---|---|---|
| Scapula mobilization | Other | Intervention |
| Shoulder ROM exercises | Other | Control, Intervention |
Primary outcome
Constant Score
Time frame: Patients will be followed for 6 months. The differences between baseline score and at the end of 6 months score will be assessed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
- 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.
Hande Guney, PhD contact
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Scapula mobilization and Shoulder ROM exercises in people with Humeral Fracture, run by Hacettepe University.
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 6 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: status not confirmed, as of the sponsor's last update on 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hande Guney, PhD (hande.guney@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant Score (time frame: Patients will be followed for 6 months. The differences between baseline score and at the end of 6 months score will be assessed.). 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 NCT02467803, 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 10 Jun 2015.