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

NCT04222829 | Terminated

• 1 other identifier: JS-CT-2019-09
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Joint Disorder

Keywords

Shoulder joints; Shinbaro pharmacopuncture; Megadose shinbaro pharmacopuncture; Chronic shoulder pain; Shoulder pain

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale of shoulder pain

  The extent of shoulder pain and discomfort was assessed using NRS. NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participant is asked to report their shoulder pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.

  At 2 weeks

Secondary Outcomes (7)

• Visual Analogue Scale of shoulder pain

  At screening, baseline, 2 weeks and through study completion, an average of 3 month

• Shoulder mobility on the Shoulder ROM

  At baseline, 2 weeks and through study completion, an average of 3 month

• Shoulder Pain and Disability Index questionnaire of shoulder pain and disability

  At baseline, 2 weeks, 3 months

• Patient Global Impression of Change

  At baseline, 2 weeks, 3 months

• EuroQol 5-Dimension

  At baseline, 2 weeks, 3 months

Study Arms (2)

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.

Procedure: Megadose Shinbaro Pharmacopuncture

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.

Interventions

Megadose Shinbaro Pharmacopuncture PROCEDURE

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.

Megadose Shinbaro Pharmacopuncture Group

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are treated in Haeundae Jaseng Korean Medicine Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Haeundae Jaseng Hospital of Korean Medicine

Busan, 48102, South Korea

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• In-Hyuk Ha

  Jaseng Medical Foundation

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 10, 2020
• Study Start: December 4, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

KR (1)