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

Stiffness of Shoulder, Not Elsewhere Classified Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02450864
• Other study ID #: IRB 101-1810A3
• Status: Recruiting
• Phase: N/A
• First received: April 13, 2015
• Last updated: February 5, 2017
• Start date: January 1, 2013
• Est. completion date: July 31, 2019

Study information

• Verified date: February 2017
• Source: Chang Gung Memorial Hospital
• Contact: Jih-Yang Jih-Yang, MD
• Phone: 886-7-731-7123
• Email: kojy[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stiffness of Shoulder, Not Elsewhere Classified

Intervention

Other:
• ESWT
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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Kaohsiung city

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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