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
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
nclusion Criteria:
* Age between 18 and 60 years
* Shoulder pain lasting for at least six weeks
* Anterolateral shoulder pain
* Clinical diagnosis of rotator cuff-related shoulder pain based on at least two positive results among the following tests:
Neer test Hawkins-Kennedy test Jobe (Empty Can) test Painful Arc test Resisted External Rotation test
-Willingness to participate and ability to provide written informed consent
Exclusion Criteria:
* Clinically evident frozen shoulder with restricted passive external rotation
* Shoulder injection within the previous four weeks
* Cervical radiculopathy
* Acute shoulder trauma
* Marked muscle weakness suggesting a full-thickness rotator cuff tear
* Calcific tendinitis
* Neurological or systemic disease that prevents participation
* Pregnancy, postpartum period, or breastfeeding
* Inability to provide informed consent
Primary outcome measure(s)
Psychometric Properties of the Night Pain Module — Baseline and 7-10 days after baseline for the retest subgroup 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.
Trial sites (3)
Facility
City
Region
Status
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
Istanbul
Turkey (Türkiye)
Beylikduzu State Hospital
Istanbul
Turkey (Türkiye)
Mardin Training and Research Hospital
Mardin
Turkey (Türkiye)
More Istanbul Physical Medicine Rehabilitation Training and Research Hospital trials in Turkey
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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