Night Pain Module for Rotator Cuff-Related Shoulder Pain
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorIstanbul Physical Medicine Rehabilitation Training and Research Hospital
About this trial
Night pain is common in people with rotator cuff-related shoulder pain and may disturb sleep and daily life. It may include difficulty falling asleep, waking because of pain, increased pain during the night, difficulty returning to sleep, and pain when lying on the affected shoulder. However, night pain is often assessed with only one pain score or a yes/no question.
This study aims to develop and evaluate a short Night Pain Module for people with rotator cuff-related shoulder pain. The current draft contains eight items assessing different features of night pain during the previous seven days. The items may be revised after expert review and pilot testing. The validity and reliability of the final version will be examined in the main study. A subgroup of participants will complete the module again after 7-10 days. No treatment or experimental procedure will be given as part of the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 60 years
Shoulder pain lasting for at least six weeks
Anterolateral shoulder pain
Disqualifiers
Clinically evident frozen shoulder with restricted passive external rotation
Shoulder injection within the previous four weeks
Cervical radiculopathy
Acute shoulder trauma
Trial population
The study population will consist of adults aged 18-60 years with rotator cuff-related shoulder pain attending the physical medicine and rehabilitation outpatient clinics of the participating hospitals. Eligible participants will have anterolateral shoulder pain lasting at least six weeks and at least two positive shoulder provocation tests. Both female and male participants will be included. The study will not include healthy controls.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
275 Participants
are grouped into 1 trial groupGroup A: Adults With Rotator Cuff-Related Shoulder Pain
Trial outcomes
Primary outcomes
1
Psychometric Properties of the Night Pain Module
The validity and reliability of the final Night Pain Module will be evaluated. Content validity will be examined using item-level and scale-level content validity indices. Structural validity will be assessed using exploratory and confirmatory factor analyses. Internal consistency will be evaluated using Cronbach's alpha and item-total correlations. Test-retest reliability will be assessed using the intraclass correlation coefficient in clinically stable participants who complete the module again after 7-10 days.
Time frame
Baseline and 7-10 days after baseline for the retest subgroupSecondary outcomes
1
Relationship Between Night Pain Module Scores and Sleep Quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index, which has a total score ranging from 0 to 21. Higher scores indicate poorer sleep quality. The relationship between Night Pain Module scores and sleep quality will be examined. Module scores will also be compared between participants with better and poorer sleep quality.
Time frame
Baseline2
Relationship Between Night Pain Module Scores and Shoulder Pain and Disability
Shoulder pain and disability will be assessed using the Shoulder Pain and Disability Index. Its total score ranges from 0 to 100, with higher scores indicating greater shoulder pain and disability. Daytime shoulder pain intensity will also be measured using an 11-point numerical rating scale ranging from 0, indicating no pain, to 10, indicating the worst imaginable pain. The relationships of Night Pain Module scores with shoulder pain, disability, and daytime pain intensity will be examined.
Time frame
Baseline3
Relationship Between Night Pain Module Scores and Pain Catastrophizing
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale. The total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing. The relationship between Night Pain Module scores and pain catastrophizing will be examined to evaluate whether the module reflects cognitive and emotional features associated with the pain experience.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Lead sponsor
Mardin Training and Research Hospital
Collaborator
Beylikduzu State Hospital
Collaborator
Source ClinicalTrials.gov
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