Night Pain in Patients With Rotator Cuff Syndrome

May 12, 2020 updated by: Alper Mengi, Gaziosmanpasa Research and Education Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Çanakkale, Turkey, 17100
        • Alper Mengi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
7 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Demographic datas
Time Frame: 1 day
Gender, Age, Education Level, Job
1 day
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.
7 day
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.
1 day
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.
1 day
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.
7 days
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 days
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.
7 days
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.
1 day
pain duration
Time Frame: 1 day
The duration of pain will be asked to patients as months.
1 day
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.
1 day
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.
1 day
smoking history
Time Frame: 6 months
Patients will be asked about their smoking habit for the last 6 months.
6 months
diabetes history
Time Frame: 1 day
The patients will be asked whether they have diabetes disease.
1 day
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.
1 day
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.
1 day
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.
1 day
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.
1 day
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.
1 day
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.
1 day
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.
1 day
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.
1 day
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gaziosmanpasa Research and Education Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alper Mengi, M.D., Gaziosmanpasa Research and Education Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 21, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13.06.18/69

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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