Night Pain in Patients With Rotator Cuff Syndrome

NCT ID: NCT03894761

Last Updated: 2020-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-21
• Study Completion Date: 2019-12-30

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.

Conditions

Shoulder Pain; Shoulder Impingement Syndrome; Shoulder Tendinitis; Rotator Cuff Tear

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with Rotator Cuff Syndrome

The patients diagnosed with rotator cuff syndrome by clinical and magnetic resonance imaging.

Group Type: OTHER

Night Pain in Patients with Rotator Cuff Syndrome

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gaziosmanpasa Research and Education Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Alper Mengi

Medical Doctor, Physiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alper Mengi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Gaziosmanpasa Research and Education Hospital

Locations

Alper Mengi

Çanakkale, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

13.06.18/69

Identifier Type: -

Identifier Source: org_study_id