Night Pain in Patients With Rotator Cuff Syndrome

Shoulder Pain Clinical Trial

Official title:

What Are the Factors Affecting Night Pain in Patients With Rotator Cuff Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03894761
• Other study ID #: 13.06.18/69
• Status: Completed
• Phase: N/A
• Start date: March 21, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: May 2020
• Source: Gaziosmanpasa Taksim Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 (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

• 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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear
• Shoulder Impingement Syndrome
• Shoulder Pain
• Shoulder Tendinitis
• Syndrome
• Tendinopathy

Intervention

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.

Locations

Country	Name	City	State
Turkey	Alper Mengi	Çanakkale

Sponsors (1)

Lead Sponsor	Collaborator
Gaziosmanpasa Taksim Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 day
Secondary	Demographic datas	Gender, Age, Education Level, Job	1 day
Secondary	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.	7 day
Secondary	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.	1 day
Secondary	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.	1 day
Secondary	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.	7 days
Secondary	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.	7 days
Secondary	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.	7 days
Secondary	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.	1 day
Secondary	pain duration	The duration of pain will be asked to patients as months.	1 day
Secondary	history of trauma to the shoulder	It will be questioned whether patients had a history of trauma to the shoulder before.	1 day
Secondary	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.	1 day
Secondary	smoking history	Patients will be asked about their smoking habit for the last 6 months.	6 months
Secondary	diabetes history	The patients will be asked whether they have diabetes disease.	1 day
Secondary	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.	1 day
Secondary	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.	1 day
Secondary	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.	1 day
Secondary	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.	1 day
Secondary	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.	1 day
Secondary	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.	1 day
Secondary	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.	1 day
Secondary	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.	1 day
Secondary	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.	1 day