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

Rotator Cuff Tear Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04566939
• Other study ID #: JS-CT-2020-11
• Status: Completed
• Start date: September 21, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: March 2024
• Source: Jaseng Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Drug:
• Herbal medicine
Herbal medicine will be administered in water-based decoction (120ml) and dried powder (2g) form (Ostericum koreanum,Eucommia ulmoides, canthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, aposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycinemax, Atractylodes japonica) at the physician's discretion.

Procedure:
• Chuna manual medicine
Chuna is a Korean manual therapy directed at the spine and joints that incorporates various spinal manual medicine techniques for joint mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement. Chuna manual medicine will be administered to the shoulder at the physician's discretion.
• Pharmacopuncture
Pharmacopuncture consisting of select herbal ingredients will be administered at Gyunwoo (LI15), Gyunryo(TE14), Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea) at the physician's discretion.
• Acupuncture
Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
• Electroacupuncture
Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
• Cupping
Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
• Herbal hot pack
Herbal hot pack treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
• Physical therapy
The participants in the control group will be receive one or more physical therapy according to the physician's decision.
• Other intervention(s)
Patients will be allowed any other additional intervention(s) as deemed necessary regardless of type or dose, and patterns of use will be investigated and recorded as a pragmatic clinical study.

Locations

Country	Name	City	State
Korea, Republic of	Haeundae Jaseng Hospital of Korean Medicine	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Medical Foundation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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