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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Turkey (Türkiye)1 site
  • Alper Mengi

    Çanakkale, 17100

Other trials in Turkey (Türkiye)

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 groups in NCT03894761
Study groupRoleWhat they receive
Patients with Rotator Cuff SyndromeOtherThe 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.

  1. 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)
  1. Demographic datas

    Gender, Age, Education Level, Job

    Measured: 1 day

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. pain duration

    The duration of pain will be asked to patients as months.

    Measured: 1 day

  10. history of trauma to the shoulder

    It will be questioned whether patients had a history of trauma to the shoulder before.

    Measured: 1 day

  11. 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

  12. smoking history

    Patients will be asked about their smoking habit for the last 6 months.

    Measured: 6 months

  13. diabetes history

    The patients will be asked whether they have diabetes disease.

    Measured: 1 day

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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.

  1. First posted29 Mar 2019
  2. Study start21 Mar 2019
  3. Primary completion30 Dec 2019
  4. Study completion30 Dec 2019

Resources

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)
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

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.

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