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NCT07838233
Night Pain Module for Rotator Cuff-Related Shoulder Pain
Conditions: Shoulder Pain, Rotator Cuff Related Shoulder Pain
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Enrollment: 275
Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Location: Istanbul Physical Medicine and Rehabilitation Training and Research Hospital Istanbul
Summary
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
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
Source: ClinicalTrials.gov (NCT07838233). StuddyBuddy aggregates publicly available trial information.