Clinical trial Recruiting at 3 sites Observational Ages 18 to 60

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 typeObservational
Ages18 Years to 60 Years
SexAll
Enrollment275 (estimated)
SponsorIstanbul Physical Medicine Rehabilitation Training and Research Hospital
Government
Locations3 sites (Istanbul and 2 other locations)
StatusRecruiting
StartedOctober 1, 2026
Main results expectedApril 1, 2027
Study endsOctober 1, 2027
Registry record updatedOctober 27, 2026
Trial IDNCT07838233 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.