Stiffness of Shoulder, Not Elsewhere ClassifiedNCT02534558
Pathomechanism of MicroRNA-29 in Shoulder Stiffness
A study testing miR 29a in people with Stiffness of Shoulder, Not Elsewhere Classified, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stiffness of Shoulder, Not Elsewhere Classified
- What is being tested?
- miR 29a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2014to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 to 80 years
- receiving surgery for open acromioplasty
Who cannot join
- shoulder disorders caused by traumatic fracture
- previous surgery
- osteoarthritis
- malignant disorders
- hepatic disorders
- renal disorders
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Kaohsiung City, 833
Jih-Yang Ko, MD, 886-7-731-7123 ext. 8003, kojy@cgmh.org.tw
Jih-Yang Ko, MD
About this study
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.
Read the 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.
- Being tested
- miR 29a
- Keywords
- MicroRNA-29, shoulder stiffness, mir-29a
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miR 29aBiological
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
| Study group | Role | What they receive |
|---|---|---|
| miR-29a precursor oligonucleotide | Experimental | 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 Receives: Biological: miR 29a |
| miR-29a antisense oligonucleotide | Experimental | 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 Receives: Biological: miR 29a |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study start1 Aug 2014
- Primary completion31 Jul 2019 (estimated)
- Study completion31 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stiffness of Shoulder, Not Elsewhere ClassifiedStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yang-Jih Ko, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534558
- Sponsor's protocol ID
- IRB 102-5462B
- Other IDs
- ChangGungMH
- Status last verified
- Feb 2017
- First submitted
- 13 Apr 2015
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathomechanism of MicroRNA-29 in Shoulder Stiffness
- ClinicalTrials.gov ID
- NCT02534558
- Acronym / sponsor ID
- IRB 102-5462B
- Keywords
- MicroRNA-29, shoulder stiffness, mir-29a
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 31 Jul 2019 (estimated)
- First posted
- 27 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| miR-29a precursor oligonucleotide | Experimental | Biological: miR 29aEffects of IL-1β, miR-29a precursor oligonucleotide treatment on the expressions of miR-29a, miR-29b or miR-29c in cell cultures are quantified |
| miR-29a antisense oligonucleotide | Experimental | Biological: miR 29aEffects of IL-1β, miR-29a antisense oligonucleotide treatment on the expressions of miR-29a, miR-29b or miR-29c in cell cultures are quantified |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 18 to 80 years
- receiving surgery for open acromioplasty
Key exclusion criteria (6 listed)
- shoulder disorders caused by traumatic fracture
- previous surgery
- osteoarthritis
- malignant disorders
- hepatic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| miR 29aEffects 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 | Biological | miR-29a antisense oligonucleotide, miR-29a precursor oligonucleotide |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang-Jih Ko, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing miR 29a in people with Stiffness of Shoulder, Not Elsewhere Classified, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jih-Yang Ko, MD (886-7-731-7123 ext. 8003, kojy@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The microRNA expression, mRNA expression as a measure (time frame: 48hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.