回旋腱板手術後の疼痛教育 (PNE-RCS)
中程度のサイズの回旋腱板涙の外科的修復を受けている患者に対する痛み神経科学教育の効果
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Karaman、トルコ（Türkiye）
- Karaman Training and Research Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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
説明
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：OTHER
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
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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. |
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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. |
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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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pain Intensity
時間枠：Time Frame: 2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
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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. |
Time Frame: 2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
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Pressure Pain Threshold (PPT)
時間枠：2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
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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. |
2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
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Conditioned Pain Modulation (CPM)
時間枠：2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
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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. |
2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Kinesiophobia (Fear of Movement)
時間枠：2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
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Kinesiophobia will be measured using the Tampa Scale of Kinesiophobia (TSK), which assesses fear of movement and reinjury. |
2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
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Sleep Quality
時間枠：2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
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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). |
2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
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Depression and Anxiety
時間枠：2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
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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). |
2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
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Shoulder Functionality
時間枠：2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
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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). |
2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
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Modified Constant-Murley Shoulder Score (MCOS)
時間枠：2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
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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). |
2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
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Functional Impairment Test-Hand, Neck, and Shoulder (FIT-HaNSA)
時間枠：2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
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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).. |
2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Postural Alignment
時間枠：2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
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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. |
2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
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Muscle Elastography
時間枠：2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
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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. |
2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IstinyeRCT2025
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
IPD 共有時間枠
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.
IPD 共有アクセス基準
Access will be provided through a secure, controlled-access platform (e.g., [insert platform name, e.g., ClinicalStudyDataRequest.com]).
Researchers 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.
IPD 共有サポート情報タイプ
- ANALYTIC_CODE
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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