Musculoskeletal PainNCT03466307
Ultrasonographic Parameters and Life Quality in Nocturnal Shoulder Pain
An observational study of Musculoskeletal Pain, run by Suleyman Demirel University.
Trial summary
This study aimed to investigate the effects of nocturnal pain on clinical and ultrasonographic parameters in patients with rotator cuff tendinopathy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Ultrasonography
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 15 Oct 2017
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged over 18 years diagnosed with rotator cuff tendinopathy attending our physical medicine and rehabilitation outpatient clinic and healthy volunteers
Who may be able to join
- Patients aged over 18 years diagnosed with rotator cuff tendinopathy
Who cannot join
- Severe limitation and pain in head and neck movements
- Loss of strength
- Sensation and reflexes loss in the upper extremity
- Limitation in passive shoulder movements on physical examination
- Systemic rheumatic disease
- Diabetes mellitus
Show all 17Show fewer
- Malignant disease
- Active infection
- Intraarticular injection
- Trauma
- Dementia
- History of surgery
- Bilateral should pain
- Psychiatric discomfort
- Smoking history
- Antiinflammatory drugs or received physical therapy within the last 3 months
- Beck depression score of higher than 13.
About this study
Official title: Comparison of Clinical and Ultrasonographic Parameters of Rotator Cuff Tendinopathy Patients With and Without Nocturnal Pain
This study aimed to investigate the effects of nocturnal pain on clinical and ultrasonographic parameters in patients with rotator cuff tendinopathy.
Read the detailed description
Thirty patients with nocturnal pain, 30 patients without nocturnal pain, and 30 healthy subjects were included in the study. The demographic characteristics and body mass indexes of the patients were recorded. The visual analogue scale was used to determine pain severity. The American Shoulder and Elbow Surgeons Scale Assessment, Short Form-36 and Beck Depression Inventory were used to determine patients' shoulder function, general quality of life and depression levels, respectively. The peak systolic velocity and resistive index of anterior circumflex humeral artery was assessed with power doppler ultrasonography.The peak systolic velocity and resistive index of anterior circumflex humeral artery values of the affected and unaffected sides were compared.
- Conditions
- Musculoskeletal Pain
- Being tested
- Ultrasonography
- Keywords
- Nocturnal pain, shoulder pain, ultrasonography, resistive index, quality of life, anterior circumflex humeral artery
- Medical subject headings
- Musculoskeletal Pain, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDevice
Ultrasonographic examination of shoulder
| Study group | Role | What they receive |
|---|---|---|
| Group A | Thirty patients with nocturnal shoulder pain Receives: Device: Ultrasonography | |
| Group B | Thirty patients without nocturnal shoulder pain Receives: Device: Ultrasonography | |
| Group C | Healthy controls Receives: Device: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior circumflex humeral artery peak systolic velocity
Ultrasonographic examination
Measured: 1 week
Anterior circumflex humeral artery resistive index
Ultrasonographic examination
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start1 Jan 2015
- Primary completion1 Jul 2016
- Study completion15 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiğdem Aydoğan, Suleyman Demirel University
- Investigators
- Çiğdem Aydoğan, Principal investigator, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466307
- Sponsor's protocol ID
- 198
- Status last verified
- Mar 2018
- First submitted
- 21 Feb 2018
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical and Ultrasonographic Parameters of Rotator Cuff Tendinopathy Patients With and Without Nocturnal Pain
- ClinicalTrials.gov ID
- NCT03466307
- Acronym / sponsor ID
- 198
- Conditions
- Musculoskeletal Pain
- Keywords
- Nocturnal pain, shoulder pain, ultrasonography, resistive index, quality of life, anterior circumflex humeral artery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 15 Oct 2017 (actual)
- First posted
- 15 Mar 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 aimed to investigate the effects of nocturnal pain on clinical and ultrasonographic parameters in patients with rotator cuff tendinopathy.
Detailed description
Thirty patients with nocturnal pain, 30 patients without nocturnal pain, and 30 healthy subjects were included in the study. The demographic characteristics and body mass indexes of the patients were recorded. The visual analogue scale was used to determine pain severity. The American Shoulder and Elbow Surgeons Scale Assessment, Short Form-36 and Beck Depression Inventory were used to determine patients' shoulder function, general quality of life and depression levels, respectively. The peak systolic velocity and resistive index of anterior circumflex humeral artery was assessed with power doppler ultrasonography.The peak systolic velocity and resistive index of anterior circumflex humeral artery values of the affected and unaffected sides were compared.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Device: UltrasonographyThirty patients with nocturnal shoulder pain |
| Group B | – | Device: UltrasonographyThirty patients without nocturnal shoulder pain |
| Group C | – | Device: UltrasonographyHealthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged over 18 years diagnosed with rotator cuff tendinopathy attending our physical medicine and rehabilitation outpatient clinic and healthy volunteers
Key inclusion criteria (1 listed)
- Patients aged over 18 years diagnosed with rotator cuff tendinopathy
Key exclusion criteria (17 listed)
- Severe limitation and pain in head and neck movements
- Loss of strength
- Sensation and reflexes loss in the upper extremity
- Limitation in passive shoulder movements on physical examination
- Systemic rheumatic disease
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 |
|---|---|---|
| UltrasonographyUltrasonographic examination of shoulder | Device | Group A, Group B, Group C |
Primary outcome
Anterior circumflex humeral artery peak systolic velocity
Time frame: 1 week
Ultrasonographic examination
Anterior circumflex humeral artery resistive index
Time frame: 1 week
Ultrasonographic examination
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 15 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
Çiğdem Aydoğan principal investigator
Suleyman Demirel University
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Pain, run by Suleyman Demirel 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 17 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 15 Mar 2018. 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.
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?
Anterior circumflex humeral artery peak systolic velocity (time frame: 1 week). The study lists 2 primary outcomes in all. 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 15 Mar 2018.