The Effectiveness of Megadose Shinbaro Pharmacopuncture for Patients With Chronic Shoulder Pain

Jaseng Medical Foundation

Status: Terminated

Conditions: Shoulder Joint Disorder

Treatments: Procedure: Megadose Shinbaro Pharmacopuncture

Study type: Observational

Funder types: Other

Identifiers

NCT04222829

JS-CT-2019-09

Details and patient eligibility

About

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.

Full 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).

Enrollment: 36 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

36 participants in 2 patient groups

Megadose Shinbaro Pharmacopuncture Group

Description:

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.

Treatment:

Procedure: Megadose Shinbaro Pharmacopuncture

Control Group

Description:

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.