Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-01-02 @ 2:58 AM
Study NCT ID:
NCT06886932
Status:
RECRUITING
Last Update Posted:
2025-04-16
First Post:
2025-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Education After Rotator Cuff Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}, {'id': 'D000092442', 'term': 'Kinesiophobia'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-11', 'studyFirstSubmitDate': '2025-03-14', 'studyFirstSubmitQcDate': '2025-03-14', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Postural Alignment', 'timeFrame': '2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).', 'description': 'Postural alignment will be assessed using FizyoPrint Mobile Application, which evaluates posture and body composition. Participants will be photographed from the front, back, and side while standing in a relaxed position. The application will generate a detailed report of postural variables.'}, {'measure': 'Muscle Elastography', 'timeFrame': '2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).', 'description': 'Muscle stiffness and integrity will be evaluated using Shear Wave Elastography (SWE). SWE measures the mechanical properties of the supraspinatus tendon and muscle, with higher stiffness values indicating better tissue integrity.'}], 'primaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': 'Time Frame: 2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).', 'description': '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.'}, {'measure': 'Pressure Pain Threshold (PPT)', 'timeFrame': '2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).', 'description': '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.'}, {'measure': 'Conditioned Pain Modulation (CPM)', 'timeFrame': '2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Kinesiophobia (Fear of Movement)', 'timeFrame': '2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).', 'description': 'Kinesiophobia will be measured using the Tampa Scale of Kinesiophobia (TSK), which assesses fear of movement and reinjury.'}, {'measure': 'Sleep Quality', 'timeFrame': '2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).', 'description': '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).'}, {'measure': 'Depression and Anxiety', 'timeFrame': '2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).', 'description': '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).'}, {'measure': 'Shoulder Functionality', 'timeFrame': '2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).', 'description': '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).'}, {'measure': 'Modified Constant-Murley Shoulder Score (MCOS)', 'timeFrame': '2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).', 'description': '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).'}, {'measure': 'Functional Impairment Test-Hand, Neck, and Shoulder (FIT-HaNSA)', 'timeFrame': '2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).', 'description': '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)..'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain Neuroscience Education', 'Postoperative Rehabilitation', 'Rotator Cuff Tear', 'Kinesiophobia', 'Shoulder Surgery Outcomes', 'Postoperative Pain Management'], 'conditions': ['Rotator Cuff Tears', 'Postoperative Pain Management', 'Shoulder Dysfunction', 'Kinesiophobia (Fear of Movement)', 'Postoperative Rehabilitation']}, 'descriptionModule': {'briefSummary': '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\n\nPurpose: 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.\n\nWho 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.\n\nStudy Details:\n\nParticipants will be randomly assigned to one of three groups:\n\nGroup 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.\n\nThe 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).\n\nPotential Benefits:\n\nParticipants may experience reduced pain, improved shoulder function, and better overall recovery.\n\nThe study may provide valuable insights into how PNE can enhance rehabilitation outcomes for patients with rotator cuff tears.\n\nPotential Risks:\n\nSome participants may find the educational sessions time-consuming or mentally challenging.\n\nThere is a small risk of discomfort during physical assessments or rehabilitation exercises.\n\nWhy is this study important?:\n\nRotator 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.', 'detailedDescription': 'Background and Rationale\n\nRotator 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.\n\nPain 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.\n\nStudy Objectives\n\nThis study aims to:\n\nEvaluate 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.\n\nCompare 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.\n\nStudy Design\n\nThis is a randomized controlled trial with three parallel groups:\n\nGroup 1 (Control): Conventional rehabilitation only. Group 2 (Preoperative PNE): Conventional rehabilitation + PNE delivered before surgery.\n\nGroup 3 (Postoperative PNE): Conventional rehabilitation + PNE delivered after surgery.\n\nMethodology\n\nParticipants: Adults aged 18-65 with a diagnosed medium-sized rotator cuff tear scheduled for mini-open surgical repair.\n\nIntervention:\n\nPNE: 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.\n\nConventional Rehabilitation: A standardized postoperative rehabilitation program focusing on pain management, range of motion, strength training, and functional recovery.\n\nOutcome Measures:\n\nPrimary Outcomes: Pain intensity (measured by Visual Analog Scale), shoulder function (measured by Constant-Murley Score), and kinesiophobia (measured by Tampa Scale of Kinesiophobia).\n\nSecondary 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.\n\nTimeline: Participants will be assessed at baseline (pre-surgery), immediately after PNE (if applicable), and at 6 and 12 weeks post-surgery.\n\nStatistical Analysis\n\nData 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).\n\nSignificance\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nParticipants must meet the following inclusion criteria:\n\nAbility to understand and complete the informed consent form and related assessment scales in Turkish.\n\nA score of 24 or higher on the Mini-Mental State Examination (MMSE) to ensure adequate cognitive function for participation.\n\nPatients will be excluded if they have:\n\nReceived a corticosteroid injection within the last 6 weeks. Evidence of adhesive capsulitis (loss of passive external rotation greater than 50% or 30°).\n\nA history of prior cervical, thoracic, or shoulder surgery. Cervical radiculopathy, acromioclavicular pathology, shoulder instability, or a full-thickness rotator cuff tear.\n\nCalcific tendinitis, systemic diseases (e.g., inflammatory arthritis, malignancy), o', 'healthyVolunteers': False, 'eligibilityCriteria': 'Eligibility Criteria\n\nInclusion Criteria:\n\nDiagnosis 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\n\nExclusion Criteria:\n\nCorticosteroid 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'}, 'identificationModule': {'nctId': 'NCT06886932', 'acronym': 'PNE-RCS', 'briefTitle': 'Pain Education After Rotator Cuff Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Istinye University'}, 'officialTitle': 'The Effect of Pain Neuroscience Education on Patients Undergoing Surgical Repair of Moderate-Sized Rotator Cuff Tears', 'orgStudyIdInfo': {'id': 'IstinyeRCT2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ANE + Rehabilitation (Preoperative)', 'description': '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.'}, {'label': 'ANE + Conventional Rehabilitation (Postoperative)', 'description': '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.'}, {'label': 'Conventional Rehabilitation Only (Control Group)', 'description': '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'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karaman', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Karaman Training and Research Hospital', 'geoPoint': {'lat': 37.18111, 'lon': 33.215}}], 'centralContacts': [{'name': 'Elif Dilara DURMAZ, MSc, Specialist Physiotherapis', 'role': 'CONTACT', 'email': 'elifdilaradurmaz@gmail.com', 'phone': '+90 5072367034'}, {'name': 'Aynur BAŞARAN, Professor, MD', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR', 'ANALYTIC_CODE'], 'timeFrame': 'End Date: The date when access to the data will be closed. Typically, this could be a period after the data has been shared, such as a few years after the study completion.', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': 'Access will be provided through a secure, controlled-access platform (e.g., \\[insert platform name, e.g., ClinicalStudyDataRequest.com\\]).\n\nResearchers will need to submit a formal request and provide a research proposal. Access will be granted after approval by an independent data access committee and once a data use agreement has been signed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elif Dilara Durmaz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karaman Training and Research Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'invenstigator', 'investigatorFullName': 'Elif Dilara Durmaz', 'investigatorAffiliation': 'Istinye University'}}}}