Clinical trial NCT06718296: Development of the Photographic Shoulder Scale
Official title: Development of a Photographic Shoulder Scale to Assess Shoulder Movements in Daily Activities
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Shoulder Pain
Keywords: Shoulder Pain
Photographic Assessment
Shoulder Pain Assessment Scale
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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.

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.

Detailed description: The aim of our study is to develop a photographic scale that includes daily life activities involving the shoulder to assess pain and function in patients with shoulder pain. Additionally, the study aims to evaluate the structural validity and internal consistency of the developed scale.

Hypotheses:

H0: The Photographic Shoulder Scale is not valid and reliable for individuals with shoulder pain.

H1: The Photographic Shoulder Scale is valid and reliable for individuals with shoulder pain.

In the research methodology, a Patient Information Form will be used to evaluate demographic and clinical information, along with the Photographic Shoulder Scale developed by us. Additionally, the ASES (American Shoulder and Elbow Surgeons) Scale will be used to assess shoulder pain and function, the Quick DASH scale 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.

Developing a specific photographic scale to assess daily life activities in patients with shoulder pain could be useful in clinical practice for helping patients understand the scope of thequestions. This scale could contribute to identifying the difficulties in daily activities caused by shoulder pain and assist clinicians in developing treatment plans. It may also help in identifying the disability in daily life activities due to shoulder pain.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Photographic Shoulder Scale
timeFrame: 1 day
Secondary outcomes:
measure: Quick DASH
timeFrame: 1 day
measure: SF-12
timeFrame: 1 day
measure: ASES
timeFrame: 1 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Çam and Sakura City Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.