Rotator Cuff TearsPNE-RCSNCT06886932
Pain Education After Rotator Cuff Surgery
An observational study of Rotator Cuff Tears and Postoperative Pain Management, run by Elif Dilara Durmaz at 1 site in Turkey (Türkiye).
Trial summary
Study Title: The Effect of Pain Neuroscience Education Combined with Conventional Rehabilitation on Pain Management and Functional Outcomes in Patients Undergoing Mini-Open Rotator Cuff Repair Purpose: This study aims to investigate whether adding Pain Neuroscience Education (PNE) to a conventional rehabilitation… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Rotator Cuff Tears, Postoperative Pain Management, Shoulder Dysfunction
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 29 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients aged 40-75 years who have been diagnosed with a medium-sized rotator cuff tear (1-3 cm) confirmed by Magnetic Resonance Imaging (MRI) and are scheduled for surgical repair using the mini-open surgical technique. Participants must meet the following inclusion criteria: Ability to understand and complete the informed consent form and related assessment scales in Turkish. A score of 24 or higher on the Mini-Mental State Examination (MMSE) to ensure adequate cognitive function for participation. Patients will be excluded if they have: Received a corticosteroid injection within the last 6 weeks. Evidence of adhesive capsulitis (loss of passive external rotation greater than 50% or 30°). A history of prior cervical, thoracic, or shoulder surgery. Cervical radiculopathy, acromioclavicular pathology, shoulder instability, or a full-thickness rotator cuff tear. Calcific tendinitis, systemic diseases (e.g., inflammatory arthritis, malignancy), o
Who may be able to join
- Diagnosis of a medium-sized rotator cuff tear (1-3 cm) confirmed by Magnetic Resonance Imaging (MRI) and scheduled for surgical repair Age between 40 and 75 years Sufficient Turkish language proficiency to understand and complete the informed consent form and assessment scales Mini-Mental State Examination (MMSE) score ≥ 24, indicating adequate cognitive function for study participation
Who cannot join
- Corticosteroid injection received within the last 6 weeks Adhesive capsulitis, defined as loss of passive external rotation greater than 50% or 30° History of previous cervical, thoracic, or shoulder surgery Presence of cervical radiculopathy, characterized by pain and tingling radiating to the arm due to nerve root involvement Acromioclavicular joint pathology or shoulder instability causing shoulder pain Full-thickness rotator cuff tear Calcific tendinitis Systemic diseases (e.g., inflammatory arthritis, malignancy) or neurological disorders (e.g., fibromyalgia, other neurological deficits) Fracture, labral lesion, or biceps tendon injury in the affected shoulder Prior participation in a chronic pain psychological management program or presence of generalized body pain
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Training and Research Hospital
Karaman
About this study
Official title: The Effect of Pain Neuroscience Education on Patients Undergoing Surgical Repair of Moderate-Sized Rotator Cuff Tears
Study Title: The Effect of Pain Neuroscience Education Combined with Conventional Rehabilitation on Pain Management and Functional Outcomes in Patients Undergoing Mini-Open Rotator Cuff Repair
Purpose: This study aims to investigate whether adding Pain Neuroscience Education (PNE) to a conventional rehabilitation program improves pain management, physical function, and psychosocial outcomes in patients who have undergone mini-open surgery for rotator cuff tears (RCT). The study will also compare the effects of PNE when delivered before versus after surgery.
Read more
Who Can Participate: Adults aged 40-75 who have been diagnosed with a medium-sized rotator cuff tear and are scheduled for mini-open surgical repair. Participants must meet specific health criteria and be willing to participate in the rehabilitation program.
Study Details:
Participants will be randomly assigned to one of three groups:
Group 1: Conventional rehabilitation only. Group 2: Conventional rehabilitation + PNE before surgery. Group 3: Conventional rehabilitation + PNE after surgery. PNE involves educational sessions that explain the biology of pain, how the nervous system processes pain, and strategies to reduce fear and catastrophizing related to pain.
The study will last approximately 12 weeks, with regular assessments of pain levels, physical function, and psychosocial factors (e.g., fear of movement, depression, sleep quality).
Potential Benefits:
Participants may experience reduced pain, improved shoulder function, and better overall recovery.
The study may provide valuable insights into how PNE can enhance rehabilitation outcomes for patients with rotator cuff tears.
Potential Risks:
Some participants may find the educational sessions time-consuming or mentally challenging.
There is a small risk of discomfort during physical assessments or rehabilitation exercises.
Why is this study important?:
Rotator cuff tears are a common cause of shoulder pain and disability, especially in older adults. Post-surgical pain and fear of movement can slow recovery and reduce quality of life. This study will help determine whether PNE, when combined with conventional rehabilitation, can improve recovery outcomes and provide a better understanding of how timing (before or after surgery) affects its effectiveness.
Read the detailed description
Background and Rationale
Rotator cuff tears (RCT) are a leading cause of shoulder pain and disability, particularly in aging populations. The prevalence of RCT increases with age, affecting approximately 28% of individuals aged 40 and rising to 60-80% in those aged 80. Surgical repair, such as mini-open rotator cuff repair, is often required for medium to large tears or when conservative treatments fail. While surgery aims to reduce pain and restore function, postoperative recovery can be challenging due to severe pain, fear of movement (kinesiophobia), and psychosocial factors like anxiety and depression. These factors can hinder rehabilitation and delay recovery.
Pain Neuroscience Education (PNE) is an evidence-based approach that teaches patients about the biological and psychological mechanisms of pain. By helping patients understand how pain is processed by the nervous system, PNE reduces fear, catastrophizing, and negative beliefs about pain, thereby improving outcomes. While PNE has been shown to be effective in chronic pain conditions, its application in acute postoperative settings, particularly for rotator cuff repair, remains underexplored.
Study Objectives
This study aims to:
Evaluate the effectiveness of combining PNE with conventional rehabilitation in improving pain management, physical function, and psychosocial outcomes in patients undergoing mini-open rotator cuff repair.
Compare the effects of delivering PNE before surgery versus after surgery. Assess the impact of PNE on secondary outcomes, including kinesiophobia, depression, pressure pain threshold, conditioned pain modulation, sleep quality, postural alignment, and functional level.
Study Design
This is a randomized controlled trial with three parallel groups:
Group 1 (Control): Conventional rehabilitation only. Group 2 (Preoperative PNE): Conventional rehabilitation + PNE delivered before surgery.
Group 3 (Postoperative PNE): Conventional rehabilitation + PNE delivered after surgery.
Methodology
Participants: Adults aged 18-65 with a diagnosed medium-sized rotator cuff tear scheduled for mini-open surgical repair.
Intervention:
PNE: A structured educational program consisting of 2-3 sessions (45-60 minutes each) that explain the neurobiology of pain, the role of the central nervous system, and strategies to reduce pain-related fear and catastrophizing.
Conventional Rehabilitation: A standardized postoperative rehabilitation program focusing on pain management, range of motion, strength training, and functional recovery.
Outcome Measures:
Primary Outcomes: Pain intensity (measured by Visual Analog Scale), shoulder function (measured by Constant-Murley Score), and kinesiophobia (measured by Tampa Scale of Kinesiophobia).
Secondary Outcomes: Depression (measured by Beck Depression Inventory), pressure pain threshold, conditioned pain modulation, sleep quality (measured by Pittsburgh Sleep Quality Index), postural alignment, and functional level.
Timeline: Participants will be assessed at baseline (pre-surgery), immediately after PNE (if applicable), and at 6 and 12 weeks post-surgery.
Statistical Analysis
Data will be analyzed using intention-to-treat principles. Repeated-measures ANOVA will be used to compare outcomes across groups and time points. Subgroup analyses will explore the effects of PNE timing (preoperative vs. postoperative).
Significance
This study addresses a critical gap in the management of rotator cuff tears by investigating the role of PNE in enhancing postoperative recovery. If effective, PNE could be integrated into standard rehabilitation protocols to improve pain management, reduce fear of movement, and accelerate functional recovery. The study also aims to determine the optimal timing for PNE delivery, providing valuable insights for clinical practice.
- Conditions
- Rotator Cuff Tears, Postoperative Pain Management, Shoulder Dysfunction, Kinesiophobia (Fear of Movement), Postoperative Rehabilitation
- Keywords
- Pain Neuroscience Education, Postoperative Rehabilitation, Rotator Cuff Tear, Kinesiophobia, Shoulder Surgery Outcomes, Postoperative Pain Management
- Medical subject headings
- Rotator Cuff Injuries, Kinesiophobia
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 |
|---|---|---|
| ANE + Rehabilitation (Preoperative) | Patients in this group will receive Pain Neuroscience Education (ANE) before surgery, combined with a conventional rehabilitation program. The ANE will include education on pain mechanisms, neurophysiology, and the role of the central nervous system in pain perception. The conventional rehabilitation program will consist of exercises, manual therapy, and functional training tailored to rotator cuff repair recovery. | |
| ANE + Conventional Rehabilitation (Postoperative) | Patients in this group will receive Pain Neuroscience Education (ANBE) after surgery, combined with a conventional rehabilitation program. The ANBE will focus on reducing pain catastrophizing, anxiety, and kinesiophobia, while the rehabilitation program will include postoperative exercises, mobility training, and strength-building activities. | |
| Conventional Rehabilitation Only (Control Group) | Patients in this group will receive only the conventional rehabilitation program without any additional Pain Neuroscience Education. The rehabilitation program will include standard postoperative exercises, mobility training, and strength-building activities, as per the clinical guidelines for rotator cuff repair recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Description: Pain intensity will be measured using the Numeric Analog Scale (NAS). Patients will rate their pain on a scale from 0 (no pain) to 10 (worst pain imaginable). Pain intensity will be measured using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores represent worse outcomes.
Measured: Time Frame: 2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
Pressure Pain Threshold (PPT)
PPT will be measured using a digital algometer to assess changes in pain sensitivity at the shoulder region. This measures the minimum pressure required to elicit pain.
Measured: 2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
Conditioned Pain Modulation (CPM)
CPM will be evaluated to assess the efficiency of the endogenous pain modulation system. This measures the body's ability to modulate pain through conditioned stimuli.
Measured: 2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
Secondary outcomes (6)
Kinesiophobia (Fear of Movement)
Kinesiophobia will be measured using the Tampa Scale of Kinesiophobia (TSK), which assesses fear of movement and reinjury.
Measured: 2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
Sleep Quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates sleep duration, disturbances, and overall sleep quality.Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI total score ranges from 0 to 21, with higher scores indicating poorer sleep quality (i.e., a worse outcome).
Measured: 2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
Depression and Anxiety
Depression and anxiety levels will be assessed using the Depression Anxiety Stress Scale-21 (DASS-21), which consists of 21 items with three subscales: depression, anxiety, and stress. Each item is scored on a scale from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Higher scores indicate greater levels of psychological distress (i.e., a worse outcome).
Measured: 2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
Shoulder Functionality
Shoulder functionality will be assessed using the Shoulder Pain and Disability Index (SPADI), which evaluates pain and disability during daily activities. The total score ranges from 0 to 130, with higher scores indicating greater shoulder disability and pain (i.e., a worse outcome).
Measured: 2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
Modified Constant-Murley Shoulder Score (MCOS)
Shoulder Function (Modified Constant-Murley Shoulder Score) Description: Shoulder function will be evaluated using the Modified Constant-Murley Shoulder Score (MCOS), which assesses pain, activities of daily living, range of motion, and strength. The total score ranges from 0 to 100, with lower scores indicating reduced shoulder function (i.e., a worse outcome).
Measured: 2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
Functional Impairment Test-Hand, Neck, and Shoulder (FIT-HaNSA)
Functional impairment in the hand, neck, and shoulder regions will be assessed using the Functional Impairment Test-Hand, Neck, and Shoulder (FIT-HaNSA). The test consists of three subtasks, each performed for a maximum of 5 minutes, with specific stopping rules applied based on fatigue or inability to continue the task. Longer task durations indicate better functional capacity (i.e., a better outcome)..
Measured: 2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Apr 2025
- Primary completion29 Sep 2026
- Study completion29 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elif Dilara Durmaz
- Sponsor type
- University, hospital or other
- Collaborators
- Karaman Training and Research Hospital
- Responsible party
- Sponsor-investigator, Elif Dilara Durmaz, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886932
- Sponsor's protocol ID
- IstinyeRCT2025
- Acronym
- PNE-RCS
- Status last verified
- Sep 2026
- First submitted
- 14 Mar 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share de-identified individual participant data (IPD) including demographic information, clinical assessments, and key outcome measures. The data will be made available through a secure, publicly accessible data repository after the primary study results have been published. Access to the data will be provided upon request and will require submission of a research proposal for review by an independent data access committee. Data sharing will be conducted in accordance with ethical guidelines to ensure participant confidentiality and privacy.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pain Neuroscience Education on Patients Undergoing Surgical Repair of Moderate-Sized Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT06886932
- Acronym / sponsor ID
- PNE-RCS / IstinyeRCT2025
- Conditions
- Rotator Cuff Tears, Postoperative Pain Management, Shoulder Dysfunction, Kinesiophobia (Fear of Movement), Postoperative Rehabilitation
- Keywords
- Pain Neuroscience Education, Postoperative Rehabilitation, Rotator Cuff Tear, Kinesiophobia, Shoulder Surgery Outcomes, Postoperative Pain Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Elif Dilara DurmazUniversity, hospital or other
- Collaborators
- Karaman Training and Research Hospital
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 29 Sep 2026 (actual)
- Study completion
- 29 Sep 2026 (actual)
- First posted
- 20 Mar 2025 (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.
Study Title: The Effect of Pain Neuroscience Education Combined with Conventional Rehabilitation on Pain Management and Functional Outcomes in Patients Undergoing Mini-Open Rotator Cuff Repair
Purpose: This study aims to investigate whether adding Pain Neuroscience Education (PNE) to a conventional rehabilitation program improves pain management, physical function, and psychosocial outcomes in patients who have undergone mini-open surgery for rotator cuff tears (RCT). The study will also compare the effects of PNE when delivered before versus after surgery.
Who Can Participate: Adults aged 40-75 who have been diagnosed with a medium-sized rotator cuff tear and are scheduled for mini-open surgical repair. Participants must meet specific health criteria and be willing to participate in the rehabilitation program.
Study Details:
Participants will be randomly assigned to one of three groups:
Group 1: Conventional rehabilitation only. Group 2: Conventional rehabilitation + PNE before surgery. Group 3: Conventional rehabilitation + PNE after surgery. PNE involves educational sessions that explain the biology of pain, how the nervous system processes pain, and strategies to reduce fear and catastrophizing related to pain.
The study will last approximately 12 weeks, with regular assessments of pain levels, physical function, and psychosocial factors (e.g., fear of movement, depression, sleep quality).
Potential Benefits:
Participants may experience reduced pain, improved shoulder function, and better overall recovery.
The study may provide valuable insights into how PNE can enhance rehabilitation outcomes for patients with rotator cuff tears.
Potential Risks:
Some participants may find the educational sessions time-consuming or mentally challenging.
There is a small risk of discomfort during physical assessments or rehabilitation exercises.
Why is this study important?:
Rotator cuff tears are a common cause of shoulder pain and disability, especially in older adults. Post-surgical pain and fear of movement can slow recovery and reduce quality of life. This study will help determine whether PNE, when combined with conventional rehabilitation, can improve recovery outcomes and provide a better understanding of how timing (before or after surgery) affects its effectiveness.
Detailed description
Background and Rationale
Rotator cuff tears (RCT) are a leading cause of shoulder pain and disability, particularly in aging populations. The prevalence of RCT increases with age, affecting approximately 28% of individuals aged 40 and rising to 60-80% in those aged 80. Surgical repair, such as mini-open rotator cuff repair, is often required for medium to large tears or when conservative treatments fail. While surgery aims to reduce pain and restore function, postoperative recovery can be challenging due to severe pain, fear of movement (kinesiophobia), and psychosocial factors like anxiety and depression. These factors can hinder rehabilitation and delay recovery.
Pain Neuroscience Education (PNE) is an evidence-based approach that teaches patients about the biological and psychological mechanisms of pain. By helping patients understand how pain is processed by the nervous system, PNE reduces fear, catastrophizing, and negative beliefs about pain, thereby improving outcomes. While PNE has been shown to be effective in chronic pain conditions, its application in acute postoperative settings, particularly for rotator cuff repair, remains underexplored.
Study Objectives
This study aims to:
Evaluate the effectiveness of combining PNE with conventional rehabilitation in improving pain management, physical function, and psychosocial outcomes in patients undergoing mini-open rotator cuff repair.
Compare the effects of delivering PNE before surgery versus after surgery. Assess the impact of PNE on secondary outcomes, including kinesiophobia, depression, pressure pain threshold, conditioned pain modulation, sleep quality, postural alignment, and functional level.
Study Design
This is a randomized controlled trial with three parallel groups:
Group 1 (Control): Conventional rehabilitation only. Group 2 (Preoperative PNE): Conventional rehabilitation + PNE delivered before surgery.
Group 3 (Postoperative PNE): Conventional rehabilitation + PNE delivered after surgery.
Methodology
Participants: Adults aged 18-65 with a diagnosed medium-sized rotator cuff tear scheduled for mini-open surgical repair.
Intervention:
PNE: A structured educational program consisting of 2-3 sessions (45-60 minutes each) that explain the neurobiology of pain, the role of the central nervous system, and strategies to reduce pain-related fear and catastrophizing.
Conventional Rehabilitation: A standardized postoperative rehabilitation program focusing on pain management, range of motion, strength training, and functional recovery.
Outcome Measures:
Primary Outcomes: Pain intensity (measured by Visual Analog Scale), shoulder function (measured by Constant-Murley Score), and kinesiophobia (measured by Tampa Scale of Kinesiophobia).
Secondary Outcomes: Depression (measured by Beck Depression Inventory), pressure pain threshold, conditioned pain modulation, sleep quality (measured by Pittsburgh Sleep Quality Index), postural alignment, and functional level.
Timeline: Participants will be assessed at baseline (pre-surgery), immediately after PNE (if applicable), and at 6 and 12 weeks post-surgery.
Statistical Analysis
Data will be analyzed using intention-to-treat principles. Repeated-measures ANOVA will be used to compare outcomes across groups and time points. Subgroup analyses will explore the effects of PNE timing (preoperative vs. postoperative).
Significance
This study addresses a critical gap in the management of rotator cuff tears by investigating the role of PNE in enhancing postoperative recovery. If effective, PNE could be integrated into standard rehabilitation protocols to improve pain management, reduce fear of movement, and accelerate functional recovery. The study also aims to determine the optimal timing for PNE delivery, providing valuable insights for clinical practice.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ANE + Rehabilitation (Preoperative) | – | –Patients in this group will receive Pain Neuroscience Education (ANE) before surgery, combined with a conventional rehabilitation program. The ANE will include education on pain mechanisms, neurophysiology, and the role of the central nervous system in pain perception. The conventional rehabilitation program will consist of exercises, manual therapy, and functional training tailored to rotator cuff repair recovery. |
| ANE + Conventional Rehabilitation (Postoperative) | – | –Patients in this group will receive Pain Neuroscience Education (ANBE) after surgery, combined with a conventional rehabilitation program. The ANBE will focus on reducing pain catastrophizing, anxiety, and kinesiophobia, while the rehabilitation program will include postoperative exercises, mobility training, and strength-building activities. |
| Conventional Rehabilitation Only (Control Group) | – | –Patients in this group will receive only the conventional rehabilitation program without any additional Pain Neuroscience Education. The rehabilitation program will include standard postoperative exercises, mobility training, and strength-building activities, as per the clinical guidelines for rotator cuff repair recovery |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 40-75 years who have been diagnosed with a medium-sized rotator cuff tear (1-3 cm) confirmed by Magnetic Resonance Imaging (MRI) and are scheduled for surgical repair using the mini-open surgical technique. Participants must meet the following inclusion criteria: Ability to understand and complete the informed consent form and related assessment scales in Turkish. A score of 24 or higher on the Mini-Mental State Examination (MMSE) to ensure adequate cognitive function for participation. Patients will be excluded if they have: Received a corticosteroid injection within the last 6 weeks. Evidence of adhesive capsulitis (loss of passive external rotation greater than 50% or 30°). A history of prior cervical, thoracic, or shoulder surgery. Cervical radiculopathy, acromioclavicular pathology, shoulder instability, or a full-thickness rotator cuff tear. Calcific tendinitis, systemic diseases (e.g., inflammatory arthritis, malignancy), o
Key inclusion criteria (1 listed)
- Diagnosis of a medium-sized rotator cuff tear (1-3 cm) confirmed by Magnetic Resonance Imaging (MRI) and scheduled for surgical repair Age between 40 and 75 years Sufficient Turkish language proficiency to understand and complete the informed consent form and assessment scales Mini-Mental State Examination (MMSE) score ≥ 24, indicating adequate cognitive function for study participation
Key exclusion criteria (1 listed)
- Corticosteroid injection received within the last 6 weeks Adhesive capsulitis, defined as loss of passive external rotation greater than 50% or 30° History of previous cervical, thoracic, or shoulder surgery Presence of cervical radiculopathy, characterized by pain and tingling radiating to the arm due to nerve root involvement Acromioclavicular joint pathology or shoulder instability causing shoulder pain Full-thickness rotator cuff tear Calcific tendinitis Systemic diseases (e.g., inflammatory arthritis, malignancy) or neurological disorders (e.g., fibromyalgia, other neurological deficits) Fracture, labral lesion, or biceps tendon injury in the affected shoulder Prior participation in a chronic pain psychological management program or presence of generalized body pain
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
Pain Intensity
Time frame: Time Frame: 2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
Description: Pain intensity will be measured using the Numeric Analog Scale (NAS). Patients will rate their pain on a scale from 0 (no pain) to 10 (worst pain imaginable). Pain intensity will be measured using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores represent worse outcomes.
Pressure Pain Threshold (PPT)
Time frame: 2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
PPT will be measured using a digital algometer to assess changes in pain sensitivity at the shoulder region. This measures the minimum pressure required to elicit pain.
Conditioned Pain Modulation (CPM)
Time frame: 2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
CPM will be evaluated to assess the efficiency of the endogenous pain modulation system. This measures the body's ability to modulate pain through conditioned stimuli.
6 secondary outcomes
Kinesiophobia (Fear of Movement)
Time frame: 2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
Sleep Quality
Time frame: 2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
Depression and Anxiety
Time frame: 2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
Shoulder Functionality
Time frame: 2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
Modified Constant-Murley Shoulder Score (MCOS)
Time frame: 2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
Functional Impairment Test-Hand, Neck, and Shoulder (FIT-HaNSA)
Time frame: 2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. We plan to share de-identified individual participant data (IPD) including demographic information, clinical assessments, and key outcome measures. The data will be made available through a secure, publicly accessible data repository after the primary study results have been published. Access to the data will be provided upon request and will require submission of a research proposal for review by an independent data access committee. Data sharing will be conducted in accordance with ethical guidelines to ensure participant confidentiality and privacy.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Rotator Cuff Tears and Postoperative Pain Management, run by Elif Dilara Durmaz 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 1 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: finished, as of the sponsor's last update on 30 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Time Frame: 2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).). The study lists 3 primary outcomes in all. 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 30 Sep 2026.