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

Sponsor
Jaseng Medical Foundation (Other)
Overall Status
Completed
CT.gov ID
NCT04566939
Collaborator
(none)
168
1
6.3
26.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
168 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
A Long Term Follow-Up of Rotator Cuff Tear Patients Treated With Integrated Complementary and Alternative Medicine: Retrospective Chart Review and Survey Study
Actual Study Start Date :
Sep 21, 2020
Actual Primary Completion Date :
Mar 31, 2021
Actual Study Completion Date :
Mar 31, 2021

Outcome Measures

Primary Outcome Measures

  1. Shoulder Pain intensity scale: Numeric Rating Scale (NRS) [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.

Secondary Outcome Measures

  1. Functional scale: Shoulder Pain and Disability Index (SPADI) [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).

  2. 5-Level Quality of life: EuroQol 5-Dimension (EQ-5D-5L) [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).

  3. Patient Global Impression of Change (PGIC) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Haeundae Jaseng Hospital of Korean Medicine Busan Korea, Republic of 48102

Sponsors and Collaborators

  • Jaseng Medical Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
In-Hyuk Ha, KMD, Director, Jaseng Medical Foundation
ClinicalTrials.gov Identifier:
NCT04566939
Other Study ID Numbers:
  • JS-CT-2020-11
First Posted:
Sep 28, 2020
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by In-Hyuk Ha, KMD, Director, Jaseng Medical Foundation
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 10, 2022