Clinical trial NCT04222829: The Effectiveness of Megadose Shinbaro Pharmacopuncture for Patients With Chronic Shoulder Pain
Official title: Observational Study on Effectiveness of Megadose Shinbaro Pharmacopuncture for Patients With Chronic Shoulder Pain Due to the Shoulder Diseases
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Shoulder Joint Disorder
Keywords: Shoulder joints
Shinbaro pharmacopuncture
Megadose shinbaro pharmacopuncture
Chronic shoulder pain
Shoulder pain
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are treated in Haeundae Jaseng Korean Medicine Hospital

Brief summary: This study is a prospective, case-control observational trial. The investigators will compare the Megadose Shinbaro Pharmacopuncture group to the control group to analyze the effectiveness of shoulder Megadose Shinbaro Pharmacopuncture.

Detailed description: 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.

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).

Eligibility criteria: Inclusion Criteria:

* Patients with NRS ≥ 4 for shoulder pain over 3weeks
* 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 who have been diagnosed with a severe disease that may cause shoulder pain,
* 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

Primary outcomes:
measure: Numeric Rating Scale of shoulder pain
timeFrame: At 2 weeks
Secondary outcomes:
measure: Visual Analogue Scale of shoulder pain
timeFrame: At screening, baseline, 2 weeks and through study completion, an average of 3 month
measure: Shoulder mobility on the Shoulder ROM
timeFrame: At baseline, 2 weeks and through study completion, an average of 3 month
measure: Shoulder Pain and Disability Index questionnaire of shoulder pain and disability
timeFrame: At baseline, 2 weeks, 3 months
measure: Patient Global Impression of Change
timeFrame: At baseline, 2 weeks, 3 months
measure: EuroQol 5-Dimension
timeFrame: At baseline, 2 weeks, 3 months
measure: Number of Participants with Adverse events
timeFrame: Through study completion, an average of 3 month
measure: Numeric Rating Scale of shoulder pain
timeFrame: At screening, baseline, 3 months and through study completion, an average of 3 month
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Haeundae Jaseng Hospital of Korean Medicine
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha
role: STUDY_CHAIR
References: