The Biological Effect of ESWT and the Role of Proinflammatory Cytokines and Cannabinoid Receptor in Shoulder Stiffness

Study Overview
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Brief Summary
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Investigators recent data showed anti-inflammatory effect of Effect of Extracorporeal Shockwave Technology (ESWT). Little studies focused on the effect and pathomechanism of ESWT on shoulder stiffness.

Detailed Description
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First year:Investigators intend to further delineate the inflammatory mechanism, such as IL-1β, CB1, HSP in the incidence of shoulder stiffness. Second year: Investigators intend to conduct a prospective randomized double-blind study for the clinical effect of ESWT on patients with shoulder stiffness. Third year: Investigators wish to test the biologic effect of ESWT on patients with shoulder stiffness and to elucidate the molecular mechanism for this effect through a randomized comparative study.

Official Title
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The Biological Effect of Extracorporeal Shockwave Technology (ESWT) and the Role of Proinflammatory Cytokines and Cannabinoid Receptor in Shoulder Stiffness

Conditions
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Stiffness of Shoulder, Not Elsewhere Classified

Intervention / Treatment
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* Other: ESWT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 18 to 80 years receiving surgery for open acromioplasty Exclusion Criteria: shoulder disorders caused by traumatic fracture previous surgery osteoarthritis malignant disorders hepatic disorders renal disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient with ESWT<br>Preoperatively, the ROM of the shoulder is measure with the patient in a sitting position. A goniometer is used to measure the angle to which the patient could maximally passively forward flex or abduct the shoulder. External rotation and internal rotation of the shoulders are determined with the patient's arm in a resting position. The investigators assessed shoulder ROM using the SROMD. Normal shoulder ROM without scapular stabilization is considered to be 180° of forward flexion, 180° of abduction, 90° of external rotation, and 90° of internal rotation with the arm at the side. By summation of the measured deficit of ROM, the SROMD is obtained. Patients are defined as having shoulder stiffness if SROMD >270degrees. | Other: ESWT<br>* Preoperatively, the ROM of the shoulder is measure with the patient in a sitting position. A goniometer is used to measure the angle to which the patient could maximally passively forward flex or abduct the shoulder. External rotation and internal rotation of the shoulders are determined with the patient's arm in a resting position. The investigators assessed shoulder ROM using the SROMD. Normal shoulder ROM without scapular stabilization is considered to be 180° of forward flexion, 180° of abduction, 90° of external rotation, and 90° of internal rotation with the arm at the side. By summation of the measured deficit of ROM, the SROMD is obtained. Patients are defined as having shoulder stiffness if SROMD >270degrees.<br>|
| Sham Comparator: patient without ESWT<br>Preoperatively, the ROM of the shoulder is measure with the patient in a sitting position. A goniometer is used to measure the angle to which the patient could maximally passively forward flex or abduct the shoulder. External rotation and internal rotation of the shoulders are determined with the patient's arm in a resting position. The investigators assessed shoulder ROM using the SROMD. Normal shoulder ROM without scapular stabilization is considered to be 180° of forward flexion, 180° of abduction, 90° of external rotation, and 90° of internal rotation with the arm at the side. By summation of the measured deficit of ROM, the SROMD is obtained. Patients are defined as having shoulder stiffness if SROMD >270degrees. | Other: ESWT<br>* Preoperatively, the ROM of the shoulder is measure with the patient in a sitting position. A goniometer is used to measure the angle to which the patient could maximally passively forward flex or abduct the shoulder. External rotation and internal rotation of the shoulders are determined with the patient's arm in a resting position. The investigators assessed shoulder ROM using the SROMD. Normal shoulder ROM without scapular stabilization is considered to be 180° of forward flexion, 180° of abduction, 90° of external rotation, and 90° of internal rotation with the arm at the side. By summation of the measured deficit of ROM, the SROMD is obtained. Patients are defined as having shoulder stiffness if SROMD >270degrees.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the range of motion (ROM) of the shoulder as a measure | Preoperatively, the ROM of the shoulder is measure with the patient in a sitting position. A goniometer is used to measure the angle to which the patient could maximally passively forward flex or abduct the shoulder. External rotation and internal rotation of the shoulders are determined with the patient's arm in a resting position. The investigators assessed shoulder ROM using the SROMD. Normal shoulder ROM without scapular stabilization is considered to be 180° of forward flexion, 180° of abduction, 90° of external rotation, and 90° of internal rotation with the arm at the side. By summation of the measured deficit of ROM, the SROMD is obtained. Patients are defined as having shoulder stiffness if SROMD >270degrees. | 1weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stiffness of Shoulder, Not Elsewhere Classified