Clinical trial NCT03894761: Night Pain in Patients With Rotator Cuff Syndrome
Official title: What Are the Factors Affecting Night Pain in Patients With Rotator Cuff Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Shoulder Impingement Syndrome
Shoulder Tendinitis
Rotator Cuff Tear
Keywords: Pain
Shoulder
Rotator Cuff
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2019-03-29
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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 (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

Primary outcomes:
measure: Night pain: visual analogue scale
timeFrame: 7 day
Secondary outcomes:
measure: Demographic datas
timeFrame: 1 day
measure: Daytime pain: visual analogue scale
timeFrame: 7 day
measure: Range of Motion of the Shoulder
timeFrame: 1 day
measure: Pathology in magnetic resonance imaging
timeFrame: 1 day
measure: The Shoulder Pain and Disability Index
timeFrame: 7 days
measure: Tampa Scale of Kinesiophobia
timeFrame: 7 days
measure: The Short Form-36
timeFrame: 7 days
measure: Body mass index
timeFrame: 1 day
measure: pain duration
timeFrame: 1 day
measure: history of trauma to the shoulder
timeFrame: 1 day
measure: dominant hand and affected arm side
timeFrame: 1 day
measure: smoking history
timeFrame: 6 months
measure: diabetes history
timeFrame: 1 day
measure: Hawkins test
timeFrame: 1 day
measure: Neer test
timeFrame: 1 day
measure: Painful arc test
timeFrame: 1 day
measure: Jobe test
timeFrame: 1 day
measure: drop-arm test
timeFrame: 1 day
measure: Patte test
timeFrame: 1 day
measure: External rotation test
timeFrame: 1 day
measure: Lag sign test
timeFrame: 1 day
measure: Gerber lift-off test
timeFrame: 1 day
Other outcomes:
Locations:
city: Çanakkale
country: Turkey
facility: Alper Mengi
Study officials:
affiliation: Gaziosmanpasa Research and Education Hospital
name: Alper Mengi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: