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

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: Completed
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Drug: Herbal medicine; Procedure: Chuna manual medicine; Procedure: Pharmacopuncture; Procedure: Acupuncture; Procedure: Electroacupuncture; Procedure: Cupping; Procedure: Herbal hot pack; Procedure: Physical therapy; Procedure: Other intervention(s)

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: Observational
• Enrollment (Actual): 168

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder Pain intensity scale: Numeric Rating Scale (NRS)	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

Outcome Measure	Measure Description	Time Frame
Functional scale: Shoulder Pain and Disability Index (SPADI)	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)	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)	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

• Sponsor: Jaseng Medical Foundation
• Investigators: Principal Investigator: HYUN WOO CHO, PhD, Haeundae Jaseng Hospital of Korean Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Rotator cuff tear, Korean medical treatment
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID 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