NCT06718296

Brief Summary

Shoulder pain is a common cause of musculoskeletal complaints that affects home and work activities, as well as quality of life. It is the third most common musculoskeletal issue after spinal and knee pathologies. The prognosis for individuals with shoulder pain can vary, with approximately 50% still reporting symptoms six months after seeking primary care. In addition to pain, functional limitations can occur, interfering with work, hobbies, and social or sports activities. A large group of patients report persistent shoulder pain with a high rate of sick leave. As a result, the total economic cost associated with shoulder pain also becomes a significant concern. The most frequently reported clinical pathologies associated with chronic shoulder pain are rotator cuff disorders, adhesive capsulitis, and glenohumeral osteoarthritis, which collectively constitute the largest portion of all shoulder pain pathologies. Patient-reported outcome measures (PROMs) are often used to assess functional loss and disability in patients. These outcome measures provide evidence about patients' perceptions of treatment and offer data on the long-term effectiveness of interventions. For this purpose, many shoulder-specific questionnaires have been developed. Developing a tool that uses photographs representing activities to measure how much patients struggle with daily life activities could be an important alternative for shoulder patients. An example of such a scale is the Photograph Series of Daily Activities-Short Electronic Version (PHODA-SeV), which was developed for low back pain. A different photographic scale has also been developed to assess avoidance behavior in patients with shoulder pain. Similarly, developing a specific photographic scale to assess daily life activities in patients with shoulder pain could be useful in clinical practice, as it would help patients better understand the scope of the questions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

December 15, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

9 months

First QC Date

December 1, 2024

Last Update Submit

December 5, 2024

Conditions

Keywords

Shoulder PainPhotographic AssessmentShoulder Pain Assessment Scale

Outcome Measures

Primary Outcomes (1)

  • Photographic Shoulder Scale

    In the rehabilitation of the upper extremity musculoskeletal system, a 4-person team consisting of physiotherapists and orthopedists with theoretical and practical experience has prepared 30 activities consisting of movements commonly used in daily life. The team asked 3 specialists, "How important do you think it is to ask patients with shoulder pain about this activity?" and removed activities that the specialists deemed inappropriate, resulting in 16 activities. Photos were taken for these activities, and a scale consisting of 16 photos was applied as a pilot test to a group of 15 patients with shoulder pain. A question was asked, "Does this photo represent the activity as described?" Feedback on the topic was gathered. A scale was also added for pain assessment, using a rating from 0 to 10. The designed scale consists of two sections: the first section assesses pain, and the second section contains photo-based questions measuring daily life activities.

    1 day

Secondary Outcomes (3)

  • Quick DASH

    1 day

  • SF-12

    1 day

  • ASES

    1 day

Study Arms (1)

Study group

All individuals participating in the study will sign an 'Informed Consent Form', and they will be informed about what they need to do as part of the study, what situations may arise, and any questions they have will be addressed. In the research methodology, a Patient Information Form will be used to evaluate demographic and clinical information. The ASES Scale will be used to assess shoulder pain and function, the Quick DASH will be used to measure the level of disability and functional limitations, and the SF-12 Scale will be used to assess quality of life. All scales applied to the patients will be completed within one day. The re-test of the Photographic Shoulder Scale will be conducted 7 days later. Individuals who are being followed at the Orthopedics and Traumatology Department of Başakşehir Çam and Sakura City Hospital and meet the inclusion criteria will be included in the study.

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Individuals who are being followed at the Orthopedics and Traumatology Department of Başakşehir Çam and Sakura City Hospital and meet the inclusion criteria will be included in the study.

You may qualify if:

  • Individuals with traumatic or non-traumatic shoulder pain lasting for more than 3 months

You may not qualify if:

  • Individuals with neurological and/or rheumatological diseases
  • Active local or systemic infections
  • A history of cancer
  • Severe visual impairments
  • Patients with traumatic conditions awaiting surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Crookes T, Wall C, Byrnes J, Johnson T, Gill D. Chronic shoulder pain. Aust J Gen Pract. 2023 Nov;52(11):753-758. doi: 10.31128/AJGP-04-23-6790.

    PMID: 37935145BACKGROUND
  • Sousa CO, Nascimento JDS, Pozzi F, Kardouni JR, Michener LA. Shoulder Performance Activity Test (SPAT) for People With Shoulder Pain: Feasibility, Reliability, and Validity. Phys Ther. 2023 Mar 3;103(3):pzad006. doi: 10.1093/ptj/pzad006.

    PMID: 37172131BACKGROUND
  • Ansanello W, Dos Reis FJJ, Tozzo MC, Zatiti SCA, Meulders A, Vlaeyen JWS, de Oliveira AS. Development of the Avoidance Daily Activities Photo Scale for Patients With Shoulder Pain. Phys Ther. 2022 Feb 1;102(2):pzab268. doi: 10.1093/ptj/pzab268.

    PMID: 34935976BACKGROUND

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's degree graduate

Study Record Dates

First Submitted

December 1, 2024

First Posted

December 5, 2024

Study Start

December 15, 2024

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

December 10, 2024

Record last verified: 2024-12

Locations