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

Chang Gung Medical Foundation

Status: Unknown

Conditions: Stiffness of Shoulder, Not Elsewhere Classified

Treatments: Other: ESWT

Study type: Interventional

Funder types: Other

Identifiers

NCT02450864

IRB 101-1810A3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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100 participants in 2 patient groups

patient with ESWT

Experimental group

Description:

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.

Treatment:

Other: ESWT

patient without ESWT

Sham Comparator group

Description:

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.

Treatment:

Other: ESWT