Frozen ShoulderNCT02169206
Clinical Trial on Frozen Shoulder Using Bilateral Shoulder Radiography in Different Position
A study testing Bilateral shoulder anteroposterior radiography in people with Frozen Shoulder, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
This study on frozen shoulder addressed the null hypothesis that there is no difference in the motion of scapula against the thoracic wall between affected and non-affected shoulder. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- Bilateral shoulder anteroposterior radiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteIran
- Study dates
- Oct 2012to Jan 2014
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients with unilateral shoulder pain lasted for more than one month, accompanied by passive and active limitation of range of motion in all directions
Who cannot join
- bilateral involvement, history of trauma, history of surgery on the affected shoulder, history of fracture, shoulder osteoarthritis, symptoms less than one month and any signs of rotator cuff tear. MRI will be done to rull out the rotator cuff tear.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Mashhad University of Medical Sciences
Mashhad, Razavi Khorasan Province, 91375-345
About this study
This study on frozen shoulder addressed the null hypothesis that there is no difference in the motion of scapula against the thoracic wall between affected and non-affected shoulder.
Read the detailed description
Adult patients with unilateral shoulder pain lasted for more than one month, accompanied by passive and active limitation of range of motion in all directions will be included. Patients with bilateral involvement, history of trauma, history of surgery on the affected shoulder, history of fracture, shoulder osteoarthritis, symptoms less than one month and any signs of rotator cuff tear will be excluded. MR imaging will be done to exclude other pathologies and frank rotator cuff tear.
- Conditions
- Frozen Shoulder
- Being tested
- Bilateral shoulder anteroposterior radiography
- Keywords
- Frozen shoulder, scapulothoracic angle, scapulohumeral angle, acromiohumeral distance, center equator distance, shoulder radiography
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral shoulder anteroposterior radiographyRadiation
- Patient standing with the tube in front and 105 cm far from the shoulder radiating perpendicular to the cassette in the back, both arms hanging aside the trunk in 0 degrees of arm abduction, 0 degrees of rotation and 0 degrees of extension with the thumb facing forward to obtain true bilateral shoulder anteroposterior view. Voltage and exposure time differs regarding each person's body mass.
- In the same position, the patient only elevates the arm up to 90 degrees of abduction.
| Study group | Role | What they receive |
|---|---|---|
| shoulder radiography | Other | Bilateral shoulder AP standard plain x-ray in 0 and 90 degrees of arm abduction. Non-affected shoulder is used to be compared with the affected shoulder. Receives: Radiation: Bilateral shoulder anteroposterior radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic parameter (scapulothoracic angle) measured in angle
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startOct 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Reza Kachooei, Mashhad University of Medical Sciences
- Investigators
- Mohammad H Ebrahimzadeh, M.D., Study director, Mashhad University of Medical SciencesAmir R Kachooei, M.D., Principal investigator, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169206
- Sponsor's protocol ID
- 910177
- Status last verified
- Jun 2014
- First submitted
- 19 Jun 2014
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on Frozen Shoulder Using Bilateral Shoulder Radiography in Different Position
- ClinicalTrials.gov ID
- NCT02169206
- Acronym / sponsor ID
- 910177
- Conditions
- Frozen Shoulder
- Keywords
- Frozen shoulder, scapulothoracic angle, scapulohumeral angle, acromiohumeral distance, center equator distance, shoulder radiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 23 Jun 2014 (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.
This study on frozen shoulder addressed the null hypothesis that there is no difference in the motion of scapula against the thoracic wall between affected and non-affected shoulder.
Detailed description
Adult patients with unilateral shoulder pain lasted for more than one month, accompanied by passive and active limitation of range of motion in all directions will be included. Patients with bilateral involvement, history of trauma, history of surgery on the affected shoulder, history of fracture, shoulder osteoarthritis, symptoms less than one month and any signs of rotator cuff tear will be excluded. MR imaging will be done to exclude other pathologies and frank rotator cuff tear.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| shoulder radiography | Other | Radiation: Bilateral shoulder anteroposterior radiographyBilateral shoulder AP standard plain x-ray in 0 and 90 degrees of arm abduction. Non-affected shoulder is used to be compared with the affected shoulder. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients with unilateral shoulder pain lasted for more than one month, accompanied by passive and active limitation of range of motion in all directions
Key exclusion criteria (1 listed)
- bilateral involvement, history of trauma, history of surgery on the affected shoulder, history of fracture, shoulder osteoarthritis, symptoms less than one month and any signs of rotator cuff tear. MRI will be done to rull out the rotator cuff tear.
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 |
|---|---|---|
| Bilateral shoulder anteroposterior radiography1. Patient standing with the tube in front and 105 cm far from the shoulder radiating perpendicular to the cassette in the back, both arms hanging aside the trunk in 0 degrees of arm abduction, 0 degrees of rotation and 0 degrees of extension with the thumb facing forward to obtain true bilateral shoulder anteroposterior view. Voltage and exposure time differs regarding each person's body mass. 2. In the same position, the patient only elevates the arm up to 90 degrees of abduction. | Radiation | shoulder radiography |
Primary outcome
Radiographic parameter (scapulothoracic angle) measured in angle
Time frame: one year
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 23 Jun 2014.
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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.
Mohammad H Ebrahimzadeh, M.D. study director
Mashhad University of Medical Sciences
Amir R Kachooei, M.D. principal investigator
Mashhad University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral shoulder anteroposterior radiography in people with Frozen Shoulder, run by Mashhad University of Medical Sciences at 1 site in Iran.
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 1 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 23 Jun 2014. 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 Iran. 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?
Radiographic parameter (scapulothoracic angle) measured in angle (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2014.