Shoulder Pain SyndromeNCT07324343
Which Patient Group Shows Greater Improvement With Patient Education Alone in Rotator Cuff-Related Shoulder Pain? - A Cohort Study
A study testing Questionnaire Validation and Patient Education in people with Shoulder Pain Syndrome and Subacromial Pain Syndrome, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study is to determine the clinical effectiveness of patient education alone in individuals with rotator cuff-related shoulder pain and to identify which patient subgroups benefit more from this approach. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Pain Syndrome, Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
- What is being tested?
- Questionnaire Validation and Patient Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 1 Sep 2027
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 18-65 years
- Shoulder pain persisting for at least 4 weeks
- Diagnosed by an orthopedic physician with impingement, subacromial bursitis, rotator cuff (RC) tendinopathy, or partial tear
- Activity-related pain ≥3 on the NPRS
- Cognitively able to understand the education and provide written informed consent
Who cannot join
- History of shoulder surgery
- Diagnosis of frozen shoulder, full-thickness or massive rotator cuff (RC) tear, or instability
- Presence of neurological or psychiatric conditions that prevent exercise
- History of physical therapy-rehabilitation or injection treatment within the past 6 months
- Pain persisting for more than 12 months
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
İstanbul University Cerrahpasa Faculty of Health Sciences, İstanbul
Istanbul
Merve Koyuncu Cenikli Research Asistant, MSc, +90(0212) 414 15 00, merve.cenikli@iuc.edu.tr
About this study
The primary aim of this study is to determine the clinical effectiveness of patient education alone in individuals with rotator cuff-related shoulder pain and to identify which patient subgroups benefit more from this approach. In addition, the translation and cultural adaptation of the "Patient Knowledge Questionnaire (PKQ-RCRSP)" into Turkish will be carried out to measure the level of patient knowledge regarding patient education.
Read the detailed description
Individuals who present with shoulder pain to the Orthopedics and Traumatology Department, Shoulder-Elbow Surgery Outpatient Clinic of Göztepe Prof. Dr. Süleyman Yalçın City Hospital and who volunteer to participate will be included in our study. Before beginning the study, the purpose of the study will be explained to the participants, and all information regarding the study will be provided both verbally and in writing. Informed consent will be obtained from participants, confirming that they voluntarily agree to take part in the study. A total of 116 participants will be included in the study, and the PKQ-RCRSP questionnaire will be administered at baseline and after one week. Following the validation process, participants will receive two face-to-face patient education sessions. After the first patient education session, pain will be assessed at the 4th, 12th, and 24th week follow-ups using the Numerical Pain Rating Scale (NPRS); functional limitation will be assessed using the Shoulder Pain and Disability Index (SPADI); clinical improvement using the Global Rating of Change Scale (GRC); illness perception using the Brief Illness Perception Questionnaire (B-IPQ); patient knowledge level using the PKQ-RCRSP; health literacy using the European Health Literacy Survey-Short Form (HLS-EU-Q6); and physical activity level using the International Physical Activity Questionnaire (IPAQ).
- Conditions
- Shoulder Pain Syndrome, Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain, Patient Education
- Being tested
- Questionnaire Validation, Patient Education
- Keywords
- patient education, Rotator Cuff Related Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire ValidationBehavioural
During the Turkish adaptation of the PKQ-RCRSP questionnaire, written permission was obtained from the original developer. At least two experts independently translated the questionnaire into Turkish, and a single reconciled version was created. This version was back-translated by an independent translator to ensure semantic and conceptual equivalence. Revisions were made following expert panel review and pilot testing.
For validation, the PKQ-RCRSP will be administered to participants at baseline (V0). One week later (V1), the questionnaire will be repeated, and participants will be asked if their shoulder problem or knowledge has significantly changed in the past week. Those answering "Yes," who do not return, or who receive any intervention will be excluded from the test-retest analysis. Results from participants answering "No" will complete the test-retest analysis, and all participants' data will be included in other validity analyses. This concludes the validation phase.
Patient EducationBehavioural
Participants in this arm will receive structured patient education sessions for rotator cuff-related shoulder pain. The program consists of two 30-minute face-to-face sessions delivered by a physiotherapist with at least 5 years of experience in orthopedic rehabilitation. Educational topics include disease information, symptom management, treatment options, reducing fear of movement, exercise promotion, pain and stress management, physical activity recommendations, nutrition advice, and lifestyle-specific guidance. Informational brochures will be provided after the first session. The second session, delivered two weeks later, focuses on reviewing progress and enhancing motivation; no new information will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Patient Education | Experimental | Participants in this study will receive structured patient education sessions for rotator cuff-related shoulder pain. Receives: Behavioral: Questionnaire Validation; Behavioral: Patient Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale (NPRS)
Pain intensity assessed using the Numerical Pain Rating Scale (NPRS).
Measured: İmmediately before the first education session, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
Secondary outcomes (1)
Patient Knowledge Questionnaire (PKQ-RCRSP)
Patient knowledge regarding rotator cuff-related shoulder pain assessed
Measured: Baseline, immediately before the first education session, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Sep 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Pain SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Koyuncu Cenikli, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324343
- Sponsor's protocol ID
- 2150061
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Patient Group Shows Greater Improvement With Patient Education Alone in Rotator Cuff-Related Shoulder Pain? - A Cohort Study
- ClinicalTrials.gov ID
- NCT07324343
- Acronym / sponsor ID
- 2150061
- Conditions
- Shoulder Pain Syndrome, Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain, Patient Education
- Keywords
- patient education, Rotator Cuff Related Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 7 Jan 2026 (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.
The primary aim of this study is to determine the clinical effectiveness of patient education alone in individuals with rotator cuff-related shoulder pain and to identify which patient subgroups benefit more from this approach. In addition, the translation and cultural adaptation of the "Patient Knowledge Questionnaire (PKQ-RCRSP)" into Turkish will be carried out to measure the level of patient knowledge regarding patient education.
Detailed description
Individuals who present with shoulder pain to the Orthopedics and Traumatology Department, Shoulder-Elbow Surgery Outpatient Clinic of Göztepe Prof. Dr. Süleyman Yalçın City Hospital and who volunteer to participate will be included in our study. Before beginning the study, the purpose of the study will be explained to the participants, and all information regarding the study will be provided both verbally and in writing. Informed consent will be obtained from participants, confirming that they voluntarily agree to take part in the study. A total of 116 participants will be included in the study, and the PKQ-RCRSP questionnaire will be administered at baseline and after one week. Following the validation process, participants will receive two face-to-face patient education sessions. After the first patient education session, pain will be assessed at the 4th, 12th, and 24th week follow-ups using the Numerical Pain Rating Scale (NPRS); functional limitation will be assessed using the Shoulder Pain and Disability Index (SPADI); clinical improvement using the Global Rating of Change Scale (GRC); illness perception using the Brief Illness Perception Questionnaire (B-IPQ); patient knowledge level using the PKQ-RCRSP; health literacy using the European Health Literacy Survey-Short Form (HLS-EU-Q6); and physical activity level using the International Physical Activity Questionnaire (IPAQ).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Education | Experimental | Behavioral: Questionnaire Validation, Behavioral: Patient EducationParticipants in this study will receive structured patient education sessions for rotator cuff-related shoulder pain. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals aged 18-65 years
- Shoulder pain persisting for at least 4 weeks
- Diagnosed by an orthopedic physician with impingement, subacromial bursitis, rotator cuff (RC) tendinopathy, or partial tear
- Activity-related pain ≥3 on the NPRS
- Cognitively able to understand the education and provide written informed consent
Key exclusion criteria (5 listed)
- History of shoulder surgery
- Diagnosis of frozen shoulder, full-thickness or massive rotator cuff (RC) tear, or instability
- Presence of neurological or psychiatric conditions that prevent exercise
- History of physical therapy-rehabilitation or injection treatment within the past 6 months
- Pain persisting for more than 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire ValidationDuring the Turkish adaptation of the PKQ-RCRSP questionnaire, written permission was obtained from the original developer. At least two experts independently translated the questionnaire into Turkish, and a single reconciled version was created. This version was back-translated by an independent translator to ensure semantic and conceptual equivalence. Revisions were made following expert panel review and pilot testing. For validation, the PKQ-RCRSP will be administered to participants at baseline (V0). One week later (V1), the questionnaire will be repeated, and participants will be asked if their shoulder problem or knowledge has significantly changed in the past week. Those answering "Yes," who do not return, or who receive any intervention will be excluded from the test-retest analysis. Results from participants answering "No" will complete the test-retest analysis, and all participants' data will be included in other validity analyses. This concludes the validation phase. | Behavioural | Patient Education |
| Patient EducationParticipants in this arm will receive structured patient education sessions for rotator cuff-related shoulder pain. The program consists of two 30-minute face-to-face sessions delivered by a physiotherapist with at least 5 years of experience in orthopedic rehabilitation. Educational topics include disease information, symptom management, treatment options, reducing fear of movement, exercise promotion, pain and stress management, physical activity recommendations, nutrition advice, and lifestyle-specific guidance. Informational brochures will be provided after the first session. The second session, delivered two weeks later, focuses on reviewing progress and enhancing motivation; no new information will be provided. | Behavioural | Patient Education |
Primary outcome
Numerical Pain Rating Scale (NPRS)
Time frame: İmmediately before the first education session, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
Pain intensity assessed using the Numerical Pain Rating Scale (NPRS).
1 secondary outcome
Patient Knowledge Questionnaire (PKQ-RCRSP)
Time frame: Baseline, immediately before the first education session, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.
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 3 Nov 2026.
- Individual participant dataSharing planned: No
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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?
A study testing Questionnaire Validation and Patient Education in people with Shoulder Pain Syndrome and Subacromial Pain Syndrome, 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 5 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 3 Nov 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?
Contact Merve KOYUNCU CENİKLİ Research asistant, MSc (+90(0212) 414 15 00, merve.cenikli@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Rating Scale (NPRS) (time frame: İmmediately before the first education session, and at 4 weeks, 12 weeks, and 24 weeks after the start of the education program.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026.