Shoulder PainNCT03894761
Night Pain in Patients With Rotator Cuff Syndrome
A study testing Night Pain in Patients with Rotator Cuff Syndrome in people with Shoulder Pain and Shoulder Impingement Syndrome, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the factors that may be associated with night pain in patients diagnosed with rotator cuff syndrome by clinical and magnetic resonance imaging. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Pain, Shoulder Impingement Syndrome, Shoulder Tendinitis
- What is being tested?
- Night Pain in Patients with Rotator Cuff Syndrome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Mar 2019to 30 Dec 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be diagnosed with rototor cuff pathology by magnetic resonance imaging
- Age range between 18-65 years old
- To be literate and cooperative
Who cannot join
- Having shoulder pathology other than rototor cuff pathology (Glenohumeral instability, Bisipital tendon lesions, Glenohumeral joint osteoarthritis, Acromioclavicular joint osteoarthritis, Milwaukee shoulder)
- Having complete rotator cuff tear
- Patients with a history of shoulder or cervical surgery
- The presence of cervical pathology
- Patients with a history of fracture in the shoulder with pain
- Local corticosteroid injection history for the shoulder (over the last 6 months) and using painkiller regularly
Show all 11Show fewer
- Physical therapy history for the shoulder (in the last 3 months)
- The presence of systemic inflammatory disease
- Malignancy
- Pregnancy
- A history of any psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: What Are the Factors Affecting Night Pain in Patients With Rotator Cuff Syndrome
The aim of this study is to determine the factors that may be associated with night pain in patients diagnosed with rotator cuff syndrome by clinical and magnetic resonance imaging.
Read the detailed description
Patients who were diagnosed as rotator cuff syndrome by clinical examination and magnetic resonance imaging will be included in this prospective study.
Demographic data (gender, age, education level, occupation), shoulder pain duration, history of trauma to the shoulder, smoking, dominant arm and diabetes will be questioned and body mass indexes will be calculated. Active shoulder range of motion of the patients will be measured by goniometer and recorded .
Specific tests, which are important for rotator cuff lesion, will be performed to determine whether they are positive or not.
Magnetic resonance imaging of the patients with shoulder pathology will be recorded.
A visual analog scale will be used to determine the intensity of day and night pain. Shoulder Shoulder Pain and Disability Index to assess shoulder disability of patients, SF-36 form will be filled by patient to evaluate the effect of shoulder pathology and Kinesiophobia Score to assess the avoidance of pain induced movement.
- Being tested
- Night Pain in Patients with Rotator Cuff Syndrome
- Keywords
- Pain, Shoulder, Rotator Cuff
- Medical subject headings
- Shoulder Pain, Shoulder Impingement Syndrome, Rotator Cuff Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Night Pain in Patients with Rotator Cuff SyndromeOther
The pain severity was evaluated using a 10 cm visual analogue scale , where 0 represented no pain, while 10 represented unbearable pain.At evaluation, the average of the pain during night for the last one week were inquired.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Rotator Cuff Syndrome | Other | The patients diagnosed with rotator cuff syndrome by clinical and magnetic resonance imaging. Receives: Other: Night Pain in Patients with Rotator Cuff Syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Night pain: visual analogue scale
The pain severity was evaluated using a 10 cm visual analogue scale , where 0 represented no pain, while 10 represented unbearable pain.At evaluation, the average of the pain during night for the last one week were inquired.
Measured: 7 day
Secondary outcomes (22)
Demographic datas
Gender, Age, Education Level, Job
Measured: 1 day
Daytime pain: visual analogue scale
The pain severity was evaluated using a 10 cm visual analogue scale , where 0 represented no pain, while 10 represented unbearable pain.At evaluation, the average of the pain during daytime for the last one week were inquired.
Measured: 7 day
Range of Motion of the Shoulder
The shoulder range of motion of the patients will be measured in the form of active range of motion and using a goniometer. The shoulder range of motion will be measured as flexion, extension, internal rotation, external rotation, abduction and adduction.
Measured: 1 day
Pathology in magnetic resonance imaging
The rotator cuff pathologies will be evaluated in MR imaging as subacromial-subdeltoid effusion, supraspinatus muscle tendinosis, supraspinatus muscle tear, supraspinatus muscle calcific tendinitis, infraspinatus muscle tendinosis, infraspinatus muscle tear, teres minör muscle tendinosis, teres minör muscle tear, subscapularis muscle tendinosis, subscapularis muscle tear.
Measured: 1 day
The Shoulder Pain and Disability Index
The Shoulder Pain and Disability Index (SPDA) is a self-administered questionnaire that consists of two dimensions (for pain and for functional activities). The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use.
Each of the 13 items is to be rated with a number from 0 to 10:
- For the pain score (first 5 items): 0 means no pain and 10 means worst pain imaginable;
- For the disability score (last 8 items): 0 means no impairment and 10 means the patient requires help to perform that action.
Scores could theoretically range from 0 to 100 with higher scores indicating greater impairment. The total SPADI score was calculated by averaging the pain and disability subscale scores. The total SPADI score could also range from 0 to 100.
Measured: 7 days
Tampa Scale of Kinesiophobia
Tampa Scale of Kinesiophobia is a 17-item self report checklist using a 4-point Likert scale that was developed as a measure of fear of movement or (re)injury.
The TSK is a self-completed questionnaire and the range of scores are from 17 to 68 where the higher scores indicate an increasing degree of kinesiophobia.
Measured: 7 days
The Short Form-36
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: 7 days
Body mass index
The formula is Body mass index = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.
Measured: 1 day
pain duration
The duration of pain will be asked to patients as months.
Measured: 1 day
history of trauma to the shoulder
It will be questioned whether patients had a history of trauma to the shoulder before.
Measured: 1 day
dominant hand and affected arm side
The patients will be asked which hands are dominant (right or left), and the side with shoulder pain (right or lelft) will be recorded.
Measured: 1 day
smoking history
Patients will be asked about their smoking habit for the last 6 months.
Measured: 6 months
diabetes history
The patients will be asked whether they have diabetes disease.
Measured: 1 day
Hawkins test
Hawkins test is performed by elevating the patient's arm forward to 90 degrees while forcibly internally rotating the shoulder. Patients will be evaluated for positive test or negative test.
Measured: 1 day
Neer test
Neer test is performed by placing the arm in forced flexion with the arm fully pronated . The scapula is stabilized during the maneuver to prevent scapulothoracic motion. Patients will be evaluated for positive test or negative test.
Measured: 1 day
Painful arc test
The patient fully abducts their arm in the scapular plane , and is considered positive if the patient reports pain between 60 degrees and 120 degrees of abduction.
Measured: 1 day
Jobe test
The patient's arm elevates to 90 degrees in the scapular plane, with the elbow extended, full internal rotation, and pronation of the forearm. This results in a thumbs-down position, as if the patient were pouring liquid out of a can, and the patient tries to resist this motion. This test is considered positive if the patient experiences pain or weakness with resistance.
Measured: 1 day
drop-arm test
This test is performed by passively abducting the patient's shoulder, then observing as the patient slowly lowers the arm to the waist. Patients will be evaluated for positive test or negative test.
Measured: 1 day
Patte test
The examiner places the patient's arm to 90 degrees in the scapular plane and flexes the elbow to 90 degrees . The patient is then asked to externally rotate against resistance. The test is positive if the patient is unable to perform external rotation.
Measured: 1 day
External rotation test
The examiner passively flexes the patient's elbow to 90 degrees and brings the shoulder into a position of 20 degrees of scaption. Next, the examiner passively takes the patient's shoulder into a position of maximal lateral rotation. The patient in then instructed to hold that position. A positive test is if the patient cannot maintain the position and the shoulder rotates internally.
Measured: 1 day
Lag sign test
The elbow is passively flexed to 90° and the shoulder abducted to 90° and held 5° off maximal external rotation. The patient is then asked to maintain the position actively while the examiner releases the wrist while maintaining support through the elbow.Patients will be evaluated for positive test or negative test.
Measured: 1 day
Gerber lift-off test
The patient is examined in standing and is asked to place their hand behind their back with the dorsum of the hand resting in the region of the mid- lumbar spine. The dorsum of the hand is raised off the back by maintaining or increasing internal rotation of the humerus and extension at the shoulder.
Inability to move the dorsum off the back constitutes an abnormal lift-off test and indicates subscapularis rupture or dysfunction.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start21 Mar 2019
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alper Mengi, Gaziosmanpasa Research and Education Hospital
- Investigators
- Alper Mengi, M.D., Principal investigator, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894761
- Sponsor's protocol ID
- 13.06.18/69
- Status last verified
- May 2020
- First submitted
- 21 Mar 2019
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are the Factors Affecting Night Pain in Patients With Rotator Cuff Syndrome
- ClinicalTrials.gov ID
- NCT03894761
- Acronym / sponsor ID
- 13.06.18/69
- Keywords
- Pain, Shoulder, Rotator Cuff
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 29 Mar 2019 (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.
The aim of this study is to determine the factors that may be associated with night pain in patients diagnosed with rotator cuff syndrome by clinical and magnetic resonance imaging.
Detailed description
Patients who were diagnosed as rotator cuff syndrome by clinical examination and magnetic resonance imaging will be included in this prospective study.
Demographic data (gender, age, education level, occupation), shoulder pain duration, history of trauma to the shoulder, smoking, dominant arm and diabetes will be questioned and body mass indexes will be calculated. Active shoulder range of motion of the patients will be measured by goniometer and recorded .
Specific tests, which are important for rotator cuff lesion, will be performed to determine whether they are positive or not.
Magnetic resonance imaging of the patients with shoulder pathology will be recorded.
A visual analog scale will be used to determine the intensity of day and night pain. Shoulder Shoulder Pain and Disability Index to assess shoulder disability of patients, SF-36 form will be filled by patient to evaluate the effect of shoulder pathology and Kinesiophobia Score to assess the avoidance of pain induced movement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Rotator Cuff Syndrome | Other | Other: Night Pain in Patients with Rotator Cuff SyndromeThe patients diagnosed with rotator cuff syndrome by clinical and magnetic resonance imaging. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To be diagnosed with rototor cuff pathology by magnetic resonance imaging
- Age range between 18-65 years old
- To be literate and cooperative
Key exclusion criteria (11 listed)
- Having shoulder pathology other than rototor cuff pathology (Glenohumeral instability, Bisipital tendon lesions, Glenohumeral joint osteoarthritis, Acromioclavicular joint osteoarthritis, Milwaukee shoulder)
- Having complete rotator cuff tear
- Patients with a history of shoulder or cervical surgery
- The presence of cervical pathology
- Patients with a history of fracture in the shoulder with pain
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 |
|---|---|---|
| Night Pain in Patients with Rotator Cuff SyndromeThe pain severity was evaluated using a 10 cm visual analogue scale , where 0 represented no pain, while 10 represented unbearable pain.At evaluation, the average of the pain during night for the last one week were inquired. | Other | Patients with Rotator Cuff Syndrome |
Primary outcome
Night pain: visual analogue scale
Time frame: 7 day
The pain severity was evaluated using a 10 cm visual analogue scale , where 0 represented no pain, while 10 represented unbearable pain.At evaluation, the average of the pain during night for the last one week were inquired.
22 secondary outcomes
Demographic datas
Time frame: 1 day
Daytime pain: visual analogue scale
Time frame: 7 day
Range of Motion of the Shoulder
Time frame: 1 day
Pathology in magnetic resonance imaging
Time frame: 1 day
The Shoulder Pain and Disability Index
Time frame: 7 days
Tampa Scale of Kinesiophobia
Time frame: 7 days
The Short Form-36
Time frame: 7 days
Body mass index
Time frame: 1 day
pain duration
Time frame: 1 day
history of trauma to the shoulder
Time frame: 1 day
dominant hand and affected arm side
Time frame: 1 day
smoking history
Time frame: 6 months
diabetes history
Time frame: 1 day
Hawkins test
Time frame: 1 day
Neer test
Time frame: 1 day
Painful arc test
Time frame: 1 day
Jobe test
Time frame: 1 day
drop-arm test
Time frame: 1 day
Patte test
Time frame: 1 day
External rotation test
Time frame: 1 day
Lag sign test
Time frame: 1 day
Gerber lift-off test
Time frame: 1 day
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 13 May 2020.
- Individual participant dataSharing planned: No
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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.
Alper Mengi, M.D. principal investigator
Gaziosmanpasa Research and Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Night Pain in Patients with Rotator Cuff Syndrome in people with Shoulder Pain and Shoulder Impingement Syndrome, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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 13 May 2020. 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 Turkey (Türkiye). 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?
Night pain: visual analogue scale (time frame: 7 day). 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 13 May 2020.