Rotator Cuff TearARCSNCT07667257
Preoperative Central Sensitization and Postoperative Outcomes After Arthroscopic Rotator Cuff Repair
An observational study of Rotator Cuff Tear, run by Medipol University.
Trial summary
This prospective observational study aims to investigate the effect of preoperative central sensitization on postoperative clinical outcomes in patients undergoing arthroscopic rotator cuff repair. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Arthroscopic Rotator Cuff Repair
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2026to 30 Dec 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients aged 18-65 years with a rotator cuff tear confirmed by clinical examination and magnetic resonance imaging (MRI) who are scheduled to undergo arthroscopic rotator cuff repair at the Department of Orthopedics and Traumatology of a single tertiary care center. Eligible patients who meet the inclusion criteria and provide written informed consent will be consecutively enrolled. Preoperative and postoperative clinical evaluations, including assessment of central sensitization, pain, and shoulder function, will be performed according to the study protocol.
Who may be able to join
- Age between 18 and 65 years
- Diagnosis of rotator cuff tear confirmed by clinical examination and magnetic resonance imaging (MRI)
- Scheduled to undergo arthroscopic rotator cuff repair
- Ability to understand and complete study questionnaires
- Willingness to participate and provide informed consent
Who cannot join
- Previous surgery on the affected shoulder.
- Concomitant shoulder disorders requiring additional surgical procedures (e.g., fracture, instability, advanced glenohumeral osteoarthritis).
- History of inflammatory rheumatic disease, active infection, or malignancy affecting the shoulder.
- Neurological disorders that may influence pain perception or upper extremity function.
- Severe psychiatric illness or cognitive impairment preventing completion of the questionnaires.
- Pregnancy.
- Inability or unwillingness to provide written informed consent.
- Inability to attend the postoperative 3-month follow-up evaluation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Central Sensitization on Postoperative Clinical Outcomes in Patients Undergoing Arthroscopic Rotator Cuff Repair
This prospective observational study aims to investigate the effect of preoperative central sensitization on postoperative clinical outcomes in patients undergoing arthroscopic rotator cuff repair. Central sensitization, characterized by an increased responsiveness of the central nervous system to pain stimuli, has been associated with persistent pain and poor functional recovery in various musculoskeletal disorders. However, its impact on outcomes following arthroscopic rotator cuff repair has not been fully elucidated.
Adult patients diagnosed with a rotator cuff tear by clinical examination and magnetic resonance imaging (MRI) and scheduled for arthroscopic repair will be enrolled. Preoperative central sensitization will be assessed using the Central Sensitization Inventory (CSI), while pain intensity and shoulder function will be evaluated using the Visual Analog Scale (VAS) and the Shoulder Pain and Disability Index (SPADI), respectively. Clinical assessments will be performed preoperatively and at postoperative 3 months. The study aims to determine whether preoperative central sensitization is associated with postoperative pain and functional recovery after arthroscopic rotator cuff repair.
Read the detailed description
This prospective, single-center, observational study is designed to evaluate the impact of preoperative central sensitization on postoperative clinical outcomes in patients undergoing arthroscopic rotator cuff repair. Rotator cuff tears are among the most common causes of shoulder pain and functional disability, and although arthroscopic repair generally provides satisfactory outcomes, a considerable proportion of patients continue to experience persistent pain and functional limitations after surgery.
Recent evidence suggests that pain perception is influenced not only by structural pathology but also by alterations in central pain processing mechanisms. Central sensitization is characterized by an increased responsiveness of the central nervous system to sensory stimuli and has been associated with greater pain severity, impaired physical function, and poorer quality of life in patients with musculoskeletal disorders. However, the influence of preoperative central sensitization on postoperative recovery following arthroscopic rotator cuff repair remains insufficiently investigated.
Adult patients aged 18-65 years with a rotator cuff tear confirmed by clinical examination and magnetic resonance imaging (MRI) and scheduled for arthroscopic repair will be consecutively enrolled. Demographic and clinical characteristics, including age, sex, body mass index, symptom duration, dominant side, and affected shoulder, will be recorded. Preoperative central sensitization will be evaluated using the Central Sensitization Inventory (CSI). Pain intensity will be assessed using the Visual Analog Scale (VAS), and shoulder function will be evaluated using the Shoulder Pain and Disability Index (SPADI).
Clinical assessments will be performed at baseline (preoperatively) and at postoperative 3 months. Participants will be classified according to their preoperative CSI scores, with a CSI score of ≥40 considered indicative of central sensitization. Postoperative clinical outcomes will be compared between patients with and without central sensitization. The primary objective is to determine whether preoperative central sensitization is associated with postoperative shoulder function, while secondary objectives include evaluating its relationship with postoperative pain and overall clinical recovery.
- Conditions
- Rotator Cuff Tear
- Being tested
- Arthroscopic Rotator Cuff Repair
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic Rotator Cuff RepairProcedure or surgery
All enrolled patients will undergo standard arthroscopic rotator cuff repair according to institutional clinical practice. The study is observational, and no additional intervention will be administered as part of the research protocol.
| Study group | Role | What they receive |
|---|---|---|
| Patients With Central Sensitization | Patients with a preoperative Central Sensitization Inventory score of ≥40. Receives: Procedure: Arthroscopic Rotator Cuff Repair | |
| Patients Without Central Sensitization | Patients with a preoperative Central Sensitization Inventory score of <40. Receives: Procedure: Arthroscopic Rotator Cuff Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome: Change in SPADI Total Score
The primary outcome is the change in the total Shoulder Pain and Disability Index (SPADI) score from baseline to postoperative 3 months. The SPADI assesses shoulder pain and disability and consists of pain and disability subscales. The total score ranges from 0 to 100, with higher scores indicating greater shoulder pain and disability. Lower scores indicate better shoulder function and less pain. The change will be compared according to preoperative central sensitization status.
Measured: Baseline (preoperative) and postoperative 3 months
Secondary outcomes (2)
Change in Visual Analog Scale (VAS) Pain Score
The change in pain intensity assessed using the Visual Analog Scale (VAS). The VAS is scored from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Lower scores indicate less pain. The change from baseline (preoperative assessment) to postoperative 3 months will be evaluated.
Measured: Baseline (preoperative) and postoperative 3 months
Change in Central Sensitization Inventory (CSI) Score
The change in Central Sensitization Inventory (CSI) score used to assess symptoms related to central sensitization. The CSI score ranges from 0 to 100, with higher scores indicating greater symptoms of central sensitization. The change from baseline (preoperative assessment) to postoperative 3 months will be evaluated.
Measured: Baseline (preoperative) and postoperative 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erdal Güngör, Medipol University
- Investigators
- Erdal Güngör, M.D, Principal investigator, Istanbul Medipol University, Department of Orthopedics and Traumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667257
- Sponsor's protocol ID
- EG-RCR-CS-2026-01
- Acronym
- ARCS
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Central Sensitization on Postoperative Clinical Outcomes in Patients Undergoing Arthroscopic Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT07667257
- Acronym / sponsor ID
- ARCS / EG-RCR-CS-2026-01
- Conditions
- Rotator Cuff Tear
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 25 Jun 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.
This prospective observational study aims to investigate the effect of preoperative central sensitization on postoperative clinical outcomes in patients undergoing arthroscopic rotator cuff repair. Central sensitization, characterized by an increased responsiveness of the central nervous system to pain stimuli, has been associated with persistent pain and poor functional recovery in various musculoskeletal disorders. However, its impact on outcomes following arthroscopic rotator cuff repair has not been fully elucidated.
Adult patients diagnosed with a rotator cuff tear by clinical examination and magnetic resonance imaging (MRI) and scheduled for arthroscopic repair will be enrolled. Preoperative central sensitization will be assessed using the Central Sensitization Inventory (CSI), while pain intensity and shoulder function will be evaluated using the Visual Analog Scale (VAS) and the Shoulder Pain and Disability Index (SPADI), respectively. Clinical assessments will be performed preoperatively and at postoperative 3 months. The study aims to determine whether preoperative central sensitization is associated with postoperative pain and functional recovery after arthroscopic rotator cuff repair.
Detailed description
This prospective, single-center, observational study is designed to evaluate the impact of preoperative central sensitization on postoperative clinical outcomes in patients undergoing arthroscopic rotator cuff repair. Rotator cuff tears are among the most common causes of shoulder pain and functional disability, and although arthroscopic repair generally provides satisfactory outcomes, a considerable proportion of patients continue to experience persistent pain and functional limitations after surgery.
Recent evidence suggests that pain perception is influenced not only by structural pathology but also by alterations in central pain processing mechanisms. Central sensitization is characterized by an increased responsiveness of the central nervous system to sensory stimuli and has been associated with greater pain severity, impaired physical function, and poorer quality of life in patients with musculoskeletal disorders. However, the influence of preoperative central sensitization on postoperative recovery following arthroscopic rotator cuff repair remains insufficiently investigated.
Adult patients aged 18-65 years with a rotator cuff tear confirmed by clinical examination and magnetic resonance imaging (MRI) and scheduled for arthroscopic repair will be consecutively enrolled. Demographic and clinical characteristics, including age, sex, body mass index, symptom duration, dominant side, and affected shoulder, will be recorded. Preoperative central sensitization will be evaluated using the Central Sensitization Inventory (CSI). Pain intensity will be assessed using the Visual Analog Scale (VAS), and shoulder function will be evaluated using the Shoulder Pain and Disability Index (SPADI).
Clinical assessments will be performed at baseline (preoperatively) and at postoperative 3 months. Participants will be classified according to their preoperative CSI scores, with a CSI score of ≥40 considered indicative of central sensitization. Postoperative clinical outcomes will be compared between patients with and without central sensitization. The primary objective is to determine whether preoperative central sensitization is associated with postoperative shoulder function, while secondary objectives include evaluating its relationship with postoperative pain and overall clinical recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients With Central Sensitization | – | Procedure: Arthroscopic Rotator Cuff RepairPatients with a preoperative Central Sensitization Inventory score of ≥40. |
| Patients Without Central Sensitization | – | Procedure: Arthroscopic Rotator Cuff RepairPatients with a preoperative Central Sensitization Inventory score of <40. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients aged 18-65 years with a rotator cuff tear confirmed by clinical examination and magnetic resonance imaging (MRI) who are scheduled to undergo arthroscopic rotator cuff repair at the Department of Orthopedics and Traumatology of a single tertiary care center. Eligible patients who meet the inclusion criteria and provide written informed consent will be consecutively enrolled. Preoperative and postoperative clinical evaluations, including assessment of central sensitization, pain, and shoulder function, will be performed according to the study protocol.
Key inclusion criteria (5 listed)
- Age between 18 and 65 years
- Diagnosis of rotator cuff tear confirmed by clinical examination and magnetic resonance imaging (MRI)
- Scheduled to undergo arthroscopic rotator cuff repair
- Ability to understand and complete study questionnaires
- Willingness to participate and provide informed consent
Key exclusion criteria (8 listed)
- Previous surgery on the affected shoulder.
- Concomitant shoulder disorders requiring additional surgical procedures (e.g., fracture, instability, advanced glenohumeral osteoarthritis).
- History of inflammatory rheumatic disease, active infection, or malignancy affecting the shoulder.
- Neurological disorders that may influence pain perception or upper extremity function.
- Severe psychiatric illness or cognitive impairment preventing completion of the questionnaires.
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 |
|---|---|---|
| Arthroscopic Rotator Cuff RepairAll enrolled patients will undergo standard arthroscopic rotator cuff repair according to institutional clinical practice. The study is observational, and no additional intervention will be administered as part of the research protocol. | Procedure or surgery | Patients With Central Sensitization, Patients Without Central Sensitization |
Primary outcome
Primary Outcome: Change in SPADI Total Score
Time frame: Baseline (preoperative) and postoperative 3 months
The primary outcome is the change in the total Shoulder Pain and Disability Index (SPADI) score from baseline to postoperative 3 months. The SPADI assesses shoulder pain and disability and consists of pain and disability subscales. The total score ranges from 0 to 100, with higher scores indicating greater shoulder pain and disability. Lower scores indicate better shoulder function and less pain. The change will be compared according to preoperative central sensitization status.
2 secondary outcomes
Change in Visual Analog Scale (VAS) Pain Score
Time frame: Baseline (preoperative) and postoperative 3 months
Change in Central Sensitization Inventory (CSI) Score
Time frame: Baseline (preoperative) and postoperative 3 months
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 25 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available.
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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.
Erdal Güngör, M.D principal investigator
Istanbul Medipol University, Department of Orthopedics and Traumatology
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tear, run by Medipol University.
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 8 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: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Erdal Güngör, M.D (+905438790630, egungor_49@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome: Change in SPADI Total Score (time frame: Baseline (preoperative) and postoperative 3 months). 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 25 Jun 2026.