Shoulder PainNCT06718296
Development of the Photographic Shoulder Scale
An observational study of Shoulder Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Shoulder Pain
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2024to 1 Dec 2027
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- Individuals with traumatic or non-traumatic shoulder pain lasting for more than 3 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Çam and Sakura City Hospital
Istanbul
Derya Çelik, Derya Celik,Professor, +901111111111, derya.celik@iuc.edu.tr
About this study
Official title: Development of a Photographic Shoulder Scale to Assess Shoulder Movements in Daily Activities
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.
Read the 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.
- Conditions
- Shoulder Pain
- Keywords
- Shoulder Pain, Photographic Assessment, Shoulder Pain Assessment Scale
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (3)
Quick DASH
It was designed to differentiate and assess the physical disability and symptoms in patients with musculoskeletal disorders of the upper extremity. The primary component of the questionnaire, Quick DASH, consists of 11 items, each of which is rated on a 5-point ordinal scale (17). To calculate the total DASH score, all responses are summed and averaged. This value is then subtracted by 1, multiplied by 25, and provides a total score between 0-100 (with 100 being the worst score).
Measured: 1 day
SF-12
The Short Form 12 (SF-12) scale will be used to assess health-related quality of life. The SF-12 is a shortened version of the SF-36 Health Quality Scale. It consists of 2 components: physical and mental health. The scale includes 12 questions that assess physical, social, and mental health. A higher score indicates a better state of health and improved quality of life, while a lower score indicates a deterioration in health.
Measured: 1 day
ASES
The ASES (American Shoulder and Elbow Surgeons) Scale consists of two sections: pain and functionality. The pain assessment includes one question, while the functionality assessment consists of 10 questions. The pain question is rated from 0 (no pain) to 10 (the worst pain imaginable). The functionality questions use a four-point Likert scale, ranging from 0 (cannot do) to 3 (not difficult). The total score ranges from 0 to 100.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start15 Dec 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tulay Ulku SEVIM, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718296
- Sponsor's protocol ID
- uHbM3J19
- Status last verified
- Apr 2026
- First submitted
- 1 Dec 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37935145Sousa 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.
PubMed 37172131Ansanello 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.
PubMed 34935976
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Photographic Shoulder Scale to Assess Shoulder Movements in Daily Activities
- ClinicalTrials.gov ID
- NCT06718296
- Acronym / sponsor ID
- uHbM3J19
- Conditions
- Shoulder Pain
- Keywords
- Shoulder Pain, Photographic Assessment, Shoulder Pain Assessment Scale
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Individuals with traumatic or non-traumatic shoulder pain lasting for more than 3 months
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Photographic Shoulder Scale
Time frame: 1 day
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.
3 secondary outcomes
Quick DASH
Time frame: 1 day
SF-12
Time frame: 1 day
ASES
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Background: PubMed 37935145Crookes 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.
- Background: PubMed 37172131Sousa 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.
- Background: PubMed 34935976Ansanello 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.
Related trials for Shoulder Pain
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Photographic Shoulder Scale (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06718296, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.