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Clinical Trials/NCT02450864
NCT02450864
Unknown
Not Applicable

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

Chang Gung Memorial Hospital1 site in 1 country100 target enrollmentJanuary 1, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stiffness of Shoulder, Not Elsewhere Classified
Sponsor
Chang Gung Memorial Hospital
Enrollment
100
Locations
1
Primary Endpoint
the range of motion (ROM) of the shoulder as a measure
Last Updated
9 years ago

Overview

Brief Summary

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

1. First year:Investigators intend to further delineate the inflammatory mechanism, such as IL-1β, CB1, HSP in the incidence of shoulder stiffness. 2. Second year: Investigators intend to conduct a prospective randomized double-blind study for the clinical effect of ESWT on patients with shoulder stiffness. 3. 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.

Registry
clinicaltrials.gov
Start Date
January 1, 2013
End Date
July 31, 2019
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

the range of motion (ROM) of the shoulder as a measure

Time Frame: 1weeks

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.

Study Sites (1)

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