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.
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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
Other
Prospective
Not listed
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.
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.
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.
Kinesiophobia (Fear of Movement)
Kinesiophobia will be measured using the Tampa Scale of Kinesiophobia (TSK), which assesses fear of movement and reinjury.
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).
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).
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).
Postural Alignment
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.
Muscle Elastography
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.
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Elif Dilara Durmaz
Lead sponsor
Istinye University
Sponsor institution
Karaman Training and Research Hospital
Collaborator
