An observational study in Shoulder Pain and Rotator Cuff Related Shoulder Pain, sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital. Recruiting at 3 sites in Turkey (Türkiye). Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Observational
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.
Night pain is an important symptom in rotator cuff-related shoulder pain. It may affect falling asleep, cause waking during the night, increase the need to change position, and make it difficult to return to sleep. Pain may also increase when the person lies on the affected shoulder. These features may not be fully described by a single pain score. This study aims to develop a short and practical Night Pain Module that can assess the different features of night pain in clinical practice and research.
The current draft of the Night Pain Module contains eight items. These items assess difficulty falling asleep because of shoulder pain, the number of nights with pain-related waking, pain intensity at the time of waking, average shoulder pain during the night, increased pain when lying on the affected shoulder, pain relief after changing position, the need to change position because of pain, and difficulty returning to sleep after waking because of shoulder pain. Participants will answer the items based on their experience during the previous seven days. The number and wording of the items may be revised after expert panel review and pilot testing.
The development process will have three stages. First, the draft items will be reviewed by a multidisciplinary panel of 20 experts, including specialists in physical medicine and rehabilitation, orthopedics and traumatology, algology, and psychiatry. The experts will rate each item for clinical relevance, clarity, and ability to represent night pain. Their ratings will be used to assess content validity and to revise or remove items when necessary.
Second, the revised module will be tested in a pilot group of approximately 20-30 participants. The pilot assessment will examine whether the items are easy to understand, how long the module takes to complete, whether any items are frequently left unanswered, and whether responses are concentrated at the lowest or highest possible scores. The pilot data will not be included in the main psychometric analyses. Necessary changes will be made before the final version is used in the main study.
Third, the final version of the Night Pain Module will be evaluated in the main study sample. Its structure will be examined using exploratory and confirmatory factor analyses. These analyses will assess whether the items measure one general night pain concept or separate features, such as sleep-disturbing pain and position-related pain. Internal consistency and item-total relationships will also be evaluated.
Approximately 60 clinically stable participants who do not receive treatment for their shoulder during the interval will complete the module again after 7-10 days. These data will be used to assess test-retest reliability.
The clinical validity of the module will be evaluated by examining its relationships with the Pittsburgh Sleep Quality Index, the Shoulder Pain and Disability Index, daytime shoulder pain intensity, and the Pain Catastrophizing Scale. Module scores will also be compared between participants with better and poorer sleep quality. These analyses will show whether the module reflects the expected relationships between night pain, sleep, shoulder function, daytime pain, and pain-related thoughts. The study is observational and does not include treatment assignment or an invasive procedure.
735 studies on the registry are indexed under Shoulder Pain; 167 are open to participants now.
This study's planned enrollment of 275 is above the median of 84 across 135 observational studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →Istanbul Physical Medicine Rehabilitation Training and Research Hospital is the lead sponsor of 123 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
nclusion Criteria:
Neer test Hawkins-Kennedy test Jobe (Empty Can) test Painful Arc test Resisted External Rotation test
-Willingness to participate and ability to provide written
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults aged 18-60 years with shoulder pain lasting at least six weeks and a clinical diagnosis of rotator cuff-related shoulder pain. The diagnosis will be based on anterolateral shoulder pain and at least two positive clinical provocation tests. The study includes a single patient cohort without a healthy control group or an assigned intervention.
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 subgroup
Correlation 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: Baseline
Correlation 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: Baseline
Correlation 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: Baseline
Plan to share: No
Start is estimated for Oct 2026; primary completion for Apr 2027, 6 months later.
Of 49 non-industry observational studies under Shoulder Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 24. This study's planned 6 months is below that.
Counting every sponsor, half of 54 studies reached it within 12 months; a quarter within 4 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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