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Night Pain in Patients With Rotator Cuff Syndrome

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ClinicalTrials.gov Identifier: NCT03894761
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Alper Mengi, Gaziosmanpasa Taksim Research and Education Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Shoulder Pain Shoulder Impingement Syndrome Shoulder Tendinitis Rotator Cuff Tear Other: Night Pain in Patients with Rotator Cuff Syndrome Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: What Are the Factors Affecting Night Pain in Patients With Rotator Cuff Syndrome
Actual Study Start Date : March 21, 2019
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : October 30, 2019

Arm Intervention/treatment
Patients with Rotator Cuff Syndrome
The patients diagnosed with rotator cuff syndrome by clinical and magnetic resonance imaging.
Other: Night Pain in Patients with Rotator Cuff Syndrome
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Demographic datas [ Time Frame: 1 day ]
    Gender, Age, Education Level, Job

  2. Daytime 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 daytime for the last one week were inquired.

  3. Range of Motion of the Shoulder [ Time Frame: 1 day ]
    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.

  4. Pathology in magnetic resonance imaging [ Time Frame: 1 day ]
    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.

  5. The Shoulder Pain and Disability Index [ Time Frame: 7 days ]

    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.


  6. Tampa Scale of Kinesiophobia [ Time Frame: 7 days ]

    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.


  7. The Short Form-36 [ Time Frame: 7 days ]
    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.

  8. Body mass index [ Time Frame: 1 day ]
    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.

  9. pain duration [ Time Frame: 1 day ]
    The duration of pain will be asked to patients as months.

  10. history of trauma to the shoulder [ Time Frame: 1 day ]
    It will be questioned whether patients had a history of trauma to the shoulder before.

  11. dominant hand and affected arm side [ Time Frame: 1 day ]
    The patients will be asked which hands are dominant (right or left), and the side with shoulder pain (right or lelft) will be recorded.

  12. smoking history [ Time Frame: 6 months ]
    Patients will be asked about their smoking habit for the last 6 months.

  13. diabetes history [ Time Frame: 1 day ]
    The patients will be asked whether they have diabetes disease.

  14. Hawkins test [ Time Frame: 1 day ]
    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.

  15. Neer test [ Time Frame: 1 day ]
    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.

  16. Painful arc test [ Time Frame: 1 day ]
    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.

  17. Jobe test [ Time Frame: 1 day ]
    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.

  18. drop-arm test [ Time Frame: 1 day ]
    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.

  19. Patte test [ Time Frame: 1 day ]
    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.

  20. External rotation test [ Time Frame: 1 day ]
    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.

  21. Lag sign test [ Time Frame: 1 day ]
    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.

  22. Gerber lift-off test [ Time Frame: 1 day ]

    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.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • To be diagnosed with rototor cuff pathology by magnetic resonance imaging
  • Age range between 18-65 years old
  • To be literate and cooperative

Exclusion Criteria:

  • Having shoulder pathology other than rototor cuff pathology
  • 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)
  • Physical therapy history for the shoulder (in the last 3 months)
  • The presence of systemic inflammatory disease
  • Malignancy
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03894761


Contacts
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Contact: Omer Necati Develioglu, M.D. +90 212 945 30 00 taksimetikkurul@gmail.com
Contact: Alper Mengi, M.D. +90 537 651 03 85 a_mengi22@hotmail.com

Locations
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Turkey
Alper Mengi Recruiting
Istanbul, Turkey
Contact: Alper Mengi, M.D.    +90 537 651 03 85    a_mengi22@hotmail.com   
Sponsors and Collaborators
Gaziosmanpasa Taksim Research and Education Hospital
Investigators
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Principal Investigator: Alper Mengi, M.D. Gaziosmanpasa Taksim Research and Education Hospital

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Responsible Party: Alper Mengi, Medical Doctor, Physiatrist, Gaziosmanpasa Taksim Research and Education Hospital
ClinicalTrials.gov Identifier: NCT03894761     History of Changes
Other Study ID Numbers: 13.06.18/69
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alper Mengi, Gaziosmanpasa Taksim Research and Education Hospital:
Pain
Shoulder
Rotator Cuff
Additional relevant MeSH terms:
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Shoulder Impingement Syndrome
Shoulder Pain
Tendinopathy
Syndrome
Rotator Cuff Injuries
Disease
Pathologic Processes
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Muscular Diseases