The Effectiveness of Megadose Shinbaro Pharmacopuncture for Patients With Chronic Shoulder Pain
NCT ID: NCT04222829
Last Updated: 2022-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
36 participants
OBSERVATIONAL
2019-12-04
2021-06-01
Brief Summary
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Detailed Description
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Shinbaro is a refined herbal formulation used to treat inflamed lesions and bone diseases.
This treatment is known to be an important part of Korean medicine treatment. However, there has been no specific value for the effect of this treatment.
Therefore, The investigators conducted observational trial to analyze the effectiveness of Megadose Shinbaro Pharmacopuncture on shoulder. From Dec 2019, The investigators will collect 80 patients with Chronic shoulder pain on both or each shoulder with the numeric rating scale(NRS) over 4.
The investigators will compare pain, dysfunction, quality of life and satisfaction of patients who are treated with Korean medical treatment including Megadose Shinbaro Pharmacopuncture and patients who are treated with Korean medical treatment not including Megadose Shinbaro Pharmacopuncture.
For these two groups, The investigators will compare NRS(Numeric Rating Scale), Visual Analogue Scale(VAS), Range Of Motion(ROM), Shoulder Pain and Disability Index(SPADI), Patient Global Impression of Change (PGIC) and EuroQol 5-Dimension (EQ-5D-5L).
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Megadose Shinbaro Pharmacopuncture Group
The Megadose Shinbaro Pharmacopuncture group who are treated with korean medical treatment including Megadose Shinbaro Pharmacopuncture will be evaluated on first, second, third visit and 2weeks after baseline. And the patients will receive telephone inquires after 3months from the baseline.
The Korean medical treatment includes acupuncture, chuna and Korean herbal medicine.
Megadose Shinbaro Pharmacopuncture
Pharmacopuncture is a treatment that combines 2 of the most frequented Korean medicine treatment methods - traditional acupuncture and herbal medicine - by injecting herbal medicine extract at acupoints.
Shinbaro is a refined herbal formulation used to treat inflamed lesions and bone diseases.
Control Group
The control group who are treated with Korean medical treatment not including Megadose Shinbaro Pharmacopuncture will be evaluated on first, second, third visit and 2weeks after baseline. And the patients will receive telephone inquires after 3months from the baseline.
The Korean medical treatment includes acupuncture, chuna and Korean herbal medicine.
No interventions assigned to this group
Interventions
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Megadose Shinbaro Pharmacopuncture
Pharmacopuncture is a treatment that combines 2 of the most frequented Korean medicine treatment methods - traditional acupuncture and herbal medicine - by injecting herbal medicine extract at acupoints.
Shinbaro is a refined herbal formulation used to treat inflamed lesions and bone diseases.
Eligibility Criteria
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Inclusion Criteria
* Patients aged 19-70 years on the date they sign the consent form.
* Patients who provide consent to participate in the trial and return the informed consent form
Exclusion Criteria
* Patients with progressive neurological deficit or with serious neurological symptoms caused by spinal cord compression.
* Patients who visited a hospital in pain caused by a traffic accident.
* Patients with a severe mental illness.
* Patients who are difficult to complete the research participation agreement
19 Years
70 Years
ALL
No
Sponsors
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Jaseng Medical Foundation
OTHER
Responsible Party
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In-Hyuk Ha, KMD
Director
Principal Investigators
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In-Hyuk Ha
Role: STUDY_CHAIR
Jaseng Medical Foundation
Locations
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Haeundae Jaseng Hospital of Korean Medicine
Busan, , South Korea
Countries
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Other Identifiers
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JS-CT-2019-09
Identifier Type: -
Identifier Source: org_study_id
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