Pathomechanism of MicroRNA-29 in Shoulder Stiffness

February 5, 2017 updated by: Chang Gung Memorial Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung city, Taiwan, 833
        • Recruiting
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: miR-29a precursor oligonucleotide
Effects of IL-1β, miR-29a precursor oligonucleotide treatment on the expressions of miR-29a, miR-29b or miR-29c in cell cultures are quantified
Biological: miR 29a
Effects of IL-1β, miR-29a precursor or antisense oligonucleotide treatment on the expressions of miR-29a, miR-29b or miR-29c in cell cultures are quantified
Experimental: miR-29a antisense oligonucleotide
Effects of IL-1β, miR-29a antisense oligonucleotide treatment on the expressions of miR-29a, miR-29b or miR-29c in cell cultures are quantified
Biological: miR 29a
Effects of IL-1β, miR-29a precursor or antisense oligonucleotide treatment on the expressions of miR-29a, miR-29b or miR-29c in cell cultures are quantified

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The microRNA expression, mRNA expression as a measure
Time Frame: 48hr
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Yang-Jih Ko, MD, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Anticipated)

July 31, 2019

Study Completion (Anticipated)

July 31, 2019

Study Registration Dates

First Submitted

April 13, 2015

First Submitted That Met QC Criteria

August 25, 2015

First Posted (Estimate)

August 27, 2015

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 5, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB 102-5462B
  • ChangGungMH (Other Identifier: ChangGungMH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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