Night Pain Module for Rotator Cuff-Related Shoulder Pain

NCT07838233 | Not Yet Recruiting

• 1 other identifier: IstPRMTRH-TYY2
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Shoulder Pain; Rotator Cuff Related Shoulder Pain

Keywords

Night pain; Sleep quality; Validity and reliability; scale devolopment; rotator cuff syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 7-10 days after baseline for the retest subgroup

Secondary Outcomes (3)

• Relationship Between Night Pain Module Scores and Sleep Quality

  Baseline

• Relationship Between Night Pain Module Scores and Shoulder Pain and Disability

  Baseline

• Relationship Between Night Pain Module Scores and Pain Catastrophizing

  Baseline

Study Arms (1)

Adults With Rotator Cuff-Related Shoulder Pain

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead
• Mardin Training and Research Hospital: collaborator
• Beylikduzu State Hospital: collaborator

Study Sites (3)

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, 34186, Turkey (Türkiye)

Location

Beylikduzu State Hospital

Istanbul, 34500, Turkey (Türkiye)

Location

Mardin Training and Research Hospital

Mardin, 47100, Turkey (Türkiye)

Location

Related Publications (3)

• Longo UG, Facchinetti G, Marchetti A, Candela V, Risi Ambrogioni L, Faldetta A, De Marinis MG, Denaro V. Sleep Disturbance and Rotator Cuff Tears: A Systematic Review. Medicina (Kaunas). 2019 Aug 8;55(8):453. doi: 10.3390/medicina55080453.

  PMID: 31398952 BACKGROUND

• Mulligan EP, Brunette M, Shirley Z, Khazzam M. Sleep quality and nocturnal pain in patients with shoulder disorders. J Shoulder Elbow Surg. 2015 Sep;24(9):1452-7. doi: 10.1016/j.jse.2015.02.013. Epub 2015 Apr 1.

  PMID: 25842028 BACKGROUND

• Lewis J. Rotator cuff related shoulder pain: Assessment, management and uncertainties. Man Ther. 2016 Jun;23:57-68. doi: 10.1016/j.math.2016.03.009. Epub 2016 Mar 26.

  PMID: 27083390 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Taha Yasin YILDIRIM, M.D.

CONTACT

+90 534 220 77 17; tyasinyildirim.ftr@gmail.com

Eser Kalaoğlu, M.D.

CONTACT

+90 536 814 14 99; eserkalaoglu@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 24, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3)