Rotator Cuff TearNCT04566939
A Long Term Follow-Up of Rotator Cuff Tear Patients Treated With Integrated Complementary and Alternative Medicine
An observational study of Rotator Cuff Tear, run by Jaseng Medical Foundation at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Herbal medicine, Chuna manual medicine and Pharmacopuncture
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 168 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Sep 2020to 31 Mar 2021
- Phase
- Observational
- 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 17 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Haeundae Jaseng Hospital of Korean Medicine
Busan, 48102
About this study
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
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.
Read the 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."
- Conditions
- Rotator Cuff Tear
- Being tested
- Herbal medicine, Chuna manual medicine, Pharmacopuncture, Acupuncture, Electroacupuncture
- Keywords
- Rotator cuff tear, Korean medical treatment
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal medicineDrug
Also called Traditional 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.
Chuna manual medicineProcedure or surgery
Also called Chuna manipulation
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.
PharmacopunctureProcedure or surgery
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.
AcupunctureProcedure or surgery
Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
ElectroacupunctureProcedure or surgery
Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
CuppingProcedure or surgery
Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
Herbal hot packProcedure or surgery
Herbal hot pack treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
Physical therapyProcedure or surgery
The participants in the control group will be receive one or more physical therapy according to the physician's decision.
Other intervention(s)Procedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Finish survey by March 2021
Secondary outcomes (3)
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).
Measured: 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).
Measured: 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).
Measured: Finish survey by March 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start21 Sep 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Hyuk Ha, KMD, Jaseng Medical Foundation
- Investigators
- HYUN WOO CHO, PhD, Principal investigator, Haeundae Jaseng Hospital of Korean Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566939
- Sponsor's protocol ID
- JS-CT-2020-11
- Status last verified
- Mar 2024
- First submitted
- 24 Sep 2020
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yoo DH, Choi JY, Lee SG, Choi KW, Park HB, Kim H, Cho H, Kim SD, Kim D, Lee YJ, Park KS, Ha IH. Long-Term Follow-Up of Inpatients with Rotator Cuff Tear Who Received Integrative Korean Medicine Treatment: A Retrospective Analysis and Questionnaire Survey. Explore (NY). 2024 Mar-Apr;20(2):212-221. doi: 10.1016/j.explore.2023.08.005. Epub 2023 Aug 25.
PubMed 37689574
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04566939
- Acronym / sponsor ID
- JS-CT-2020-11
- Conditions
- Rotator Cuff Tear
- Keywords
- Rotator cuff tear, Korean medical treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 28 Sep 2020 (actual)
- 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.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Herbal medicineAlso: Traditional herbal medicineHerbal 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. | Drug | – |
| Chuna manual medicineAlso: Chuna manipulationChuna 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. | Procedure or surgery | – |
| PharmacopuncturePharmacopuncture 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. | Procedure or surgery | – |
| AcupunctureAcupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points. | Procedure or surgery | – |
| ElectroacupunctureElectroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points. | Procedure or surgery | – |
| CuppingCupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points. | Procedure or surgery | – |
| Herbal hot packHerbal hot pack treatment will be administered using mainly proximal acupuncture points and Ah-shi points. | Procedure or surgery | – |
| Physical therapyThe participants in the control group will be receive one or more physical therapy according to the physician's decision. | Procedure or surgery | – |
| 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. | Procedure or surgery | – |
Primary outcome
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.
3 secondary outcomes
Functional scale: Shoulder Pain and Disability Index (SPADI)
Time frame: Finish survey by March 2021
5-Level Quality of life: EuroQol 5-Dimension (EQ-5D-5L)
Time frame: Finish survey by March 2021
Patient Global Impression of Change (PGIC)
Time frame: Finish survey by March 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Derived from this study: PubMed 37689574Yoo DH, Choi JY, Lee SG, Choi KW, Park HB, Kim H, Cho H, Kim SD, Kim D, Lee YJ, Park KS, Ha IH. Long-Term Follow-Up of Inpatients with Rotator Cuff Tear Who Received Integrative Korean Medicine Treatment: A Retrospective Analysis and Questionnaire Survey. Explore (NY). 2024 Mar-Apr;20(2):212-221. doi: 10.1016/j.explore.2023.08.005. Epub 2023 Aug 25.
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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.
HYUN WOO CHO, PhD principal investigator
Haeundae Jaseng Hospital of Korean Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tear, run by Jaseng Medical Foundation at 1 site in South Korea.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 18 Mar 2024. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain intensity scale: Numeric Rating Scale (NRS) (time frame: Finish survey by March 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04566939, which also lists 1 linked publication.
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 18 Mar 2024.