The Effect of Pain Neuroscience Education on Patients Undergoing Surgical Repair of Moderate-Sized Rotator Cuff Tears
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Pain Intensity
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
结局指标
主要结局
Pain Intensity
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Kinesiophobia (Fear of Movement)(2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).)
- Sleep Quality(2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).)
- Depression and Anxiety(2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).)
- Shoulder Functionality(2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).)
- Modified Constant-Murley Shoulder Score (MCOS)(2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).)
- Functional Impairment Test-Hand, Neck, and Shoulder (FIT-HaNSA)(2 weeks before surgery (preoperative) and 8 weeks after surgery (postoperative).)
研究者
Elif Dilara Durmaz
invenstigator
Istinye University