A Long Term Follow-Up of Rotator Cuff Tear Patients Treated With Integrated Complementary and Alternative Medicine

March 14, 2024 updated by: In-Hyuk Ha, KMD, Jaseng Medical Foundation

A Long Term Follow-Up of Rotator Cuff Tear Patients Treated With Integrated Complementary and Alternative Medicine: Retrospective Chart Review and Survey Study

This study is a prospective observational trial. Data of 4 hospitals will be used to find out the efficacy of conservative treatment in rotator cuff tear.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

"Rotator cuff tear is known as its symptoms which are pain, limited shoulder range of motion(ROM), and the clicking sound of the shoulder.

On recent research by Health Insurance Review & Assessment Service, the number of rotator cuff tear patients has increased from 508155 to 704838 during 2013-2017. And also the research reported that the difference of effect between surgical treatments and non-surgical treatments was unremarkable. So in most cases, non-surgical treatments are applied primarily on rotator cuff tear except for some serious cases.

Physical therapy and medication are well known for the currently known non-surgical and conservative treatments, but research reported on the treatment of rotator cuff tear by using Korean medicine treatment so far has its weak level. Therefore, it is expected that this study will demonstrate the efficacy of the treatment of rotator cuff tear in Korean medicine treatment and will further pave the way for non-surgical treatment of rotator cuff tear.

Therefore, The investigators conducted an observational trial to analyze the effectiveness of Korean medicine treatment in rotator cuff tear. Retrospective data will be extracted using electronic medical records and computerized data of hospitalized patients. Based on this, investigators will conduct research in the form of a prospective survey and analyze the causal relationship and factors using the two data.

The hospital's medical records will be used to analyze the patient's condition during the hospitalization period and to determine the situation after the end of treatment through a questionnaire. The questionnaire will be developed after consultation with experts from the musculoskeletal system and related societies, and will be used for the questionnaire."

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
168

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

  • Korea, Republic of
      • Busan, Korea, Republic of, 48102
        • Haeundae Jaseng Hospital of Korean Medicine

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who ended up the hospitalization and treatment in Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital, Daejeon Jaseng Korean Medicine Hospital

Description

Inclusion Criteria:

  • Patients who had been hospitalized with symptoms of shoulder pain at Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital and Daejeon Jaseng Korean Medicine Hospital from Jan 2015 to Mar 2020.
  • Patients diagnosed with 'Rotation Cuff Tear' finding of the EMR imaging (T2-weighted MRI scan of Shoulder
  • Patients who had been hospitalized more than 3 days
  • Patients who are within age from 19 to 70

Exclusion Criteria:

  • Patients who are hospitalized by traffic accident
  • Patients who are diagnosed other serious shoulder injury that can cause shoulder pain(tumor of shoulder, acute fracture and dislocation of shoulder)
  • Patients who had treated shoulder pain at Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital and Daejeon Jaseng Korean Medicine Hospital in recent 6 months.
  • Patients who are considered impossible to attend survey by investigators.

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

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Shoulder Pain intensity scale: Numeric Rating Scale (NRS)
Time Frame: Finish survey by March 2021

The investigators will survey Shoulder Pain intensity scale: Numeric Rating Scale (NRS) before hospitalization and after discharging from 4 hospitals(Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital, and Daejeon Jaseng Korean Medicine Hospital.

The score ranges from 0 to 10. The higher scores mean a worse outcome, and the lower scores mean a better outcome.
Finish survey by March 2021

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional scale: Shoulder Pain and Disability Index (SPADI)
Time Frame: Finish survey by March 2021
The investigators will survey Functional scale: Shoulder Pain and Disability Index (SPADI) of hospitalization period and after discharging in 4 hospitals(Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital, and Daejeon Jaseng Korean Medicine Hospital).
Finish survey by March 2021
5-Level Quality of life: EuroQol 5-Dimension (EQ-5D-5L)
Time Frame: Finish survey by March 2021
The investigators will survey 5-Level Quality of life: EuroQol 5-Dimension (EQ-5D-5L) of hospitalization period and after discharging in 4 hospitals(Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital, and Daejeon Jaseng Korean Medicine Hospital).
Finish survey by March 2021
Patient Global Impression of Change (PGIC)
Time Frame: Finish survey by March 2021
The investigators will survey Patient Global Impression of Change (PGIC) of hospitalization period and after discharging in 4 hospitals(Haeundae Jaseng Korean Medicine Hospital, Jaseng Korean Medicine Hospital, Bucheon Jaseng Korean Medicine Hospital, and Daejeon Jaseng Korean Medicine Hospital).
Finish survey by March 2021

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jaseng Medical Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: HYUN WOO CHO, PhD, Haeundae Jaseng Hospital of Korean Medicine

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JS-CT-2020-11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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