Pathomechanism of MicroRNA-29 in Shoulder Stiffness

Stiffness of Shoulder, Not Elsewhere Classified Clinical Trial

Official title:

Pathomechanism of MicroRNA-29 in Shoulder Stiffness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02534558
• Other study ID #: IRB 102-5462B
• Secondary ID: ChangGungMH
• Status: Recruiting
• Phase: N/A
• First received: April 13, 2015
• Last updated: February 5, 2017
• Start date: August 1, 2014
• Est. completion date: July 31, 2019

Study information

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

Clinical Trial Summary

The team integrates experimental analyses of clinical and basic medicine and transgenic mice models. miR-29a acts a potent protective factor against excessive fibrosis in myofibroblasts of subacromial bursa tissue. Gain of miR-29a stabilizes tendon and synovial tissue homeostasis that alleviates tissue stiffness and maintains function.

Description:

Aims of first: The team will evaluate the associations among the mR-29a, miR-29b, miR-29c expression in subacromial bursa and subacromial fluid, incidence of shoulder stiffness, Constant scores, and VAS.

Aims of second: The team will isolate primary myofibroblast from subacromial bursa tissue as in vitro models and investigate the molecular events in the IL-1β modulation of miR-29a expression and the molecular mechanism underlying miR-29a inhibition of fibrotic matrix accumulation and apoptotic reactions in myofibroblast cultures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• 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

Biological:
• miR 29a
Effects of IL-1ß, miR-29a precursor or antisense oligonucleotide treatment on the expressions of miR-29a, miR-29b or miR-29c in cell cultures are quantified

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 microRNA expression, mRNA expression as a measure	Differences among incidence, microRNA expression, mRNA expression of shoulder stiffness are analyzed using non-parametric student's t-test. P value of < 0.05 is considered statistically significant.	48hr