Night Pain Module for Rotator Cuff-Related Shoulder Pain
Official title: Development and Psychometric Evaluation of a Night Pain Module in Rotator Cuff-Related Shoulder Pain
Run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital · NCT07838233 · Data updated 2026-11-12
Researchers are testing a short set of questions to measure night pain in people with rotator cuff–related shoulder pain to see if it reliably describes how sleep is affected.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 275 (estimated) |
| Sponsor | Istanbul Physical Medicine Rehabilitation Training and Research Hospital Government |
| Locations | 3 sites (Istanbul and 2 other locations) |
| Status | Recruiting |
| Started | October 1, 2026 |
| Main results expected | April 1, 2027 |
| Study ends | October 1, 2027 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT07838233 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–60 with at least six weeks of anterolateral shoulder pain and a clinical diagnosis of rotator cuff–related pain based on two or more positive provocative tests.
✕Probably not a fit
Patients with frozen shoulder, recent shoulder injections, cervical radiculopathy, acute shoulder trauma, or other conditions that limit participation may not benefit from the module development.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project aims to create and test a concise Night Pain Module to capture multiple aspects of night pain over the past week. The draft tool includes eight items addressing sleep onset, night-time awakenings, pain intensity at waking, pain during the night, positions that worsen pain, and return to sleep after waking. A multidisciplinary expert panel will review items for relevance and clarity, with pilot testing to refine the measure. The study will assess validity and reliability of the final version, with a subgroup re-evaluating the module after 7–10 days. No treatment or interventions are administered within the study.
Why it matters
Potential benefit: If successful, the Night Pain Module could provide a quick, reliable way for clinicians and researchers to quantify night pain and its impact on sleep for patients with rotator cuff–related shoulder pain.
How similar studies have gone: No randomized treatment testing is planned; prior work on night pain measurement in shoulder conditions suggests measurement development can improve symptom capture, but this specific module is novel in its concise, multi-item approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
Istanbul, Turkey (Türkiye) Recruiting -
Beylikduzu State Hospital
Istanbul, Turkey (Türkiye) Recruiting -
Mardin Training and Research Hospital
Mardin, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Taha Yasin YILDIRIM, M.D.
- Email: tyasinyildirim.ftr@gmail.com
- Phone: +90 534 220 77 17
Similar studies
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In older adults with rotator cuff–related shoulder pain, this study tests whether adding functional electrical stimulation to a shoulder exercise program improves muscle coordination and reduces impingement compared with exercises alone.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.