Shoulder Joint DisorderNCT04222829

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

An observational study of Shoulder Joint Disorder, run by Jaseng Medical Foundation at 1 site in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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. Read more about this study

Who is it for?: Ages 19 to 70 years
Conditions the study is for: Shoulder Joint Disorder
What is being tested?: Megadose Shinbaro Pharmacopuncture
Type of treatment: Surgery or procedure
How many people: 36 participants
Where: 1 siteSouth Korea
Study dates: 4 Dec 2019to 1 Jun 2021
How long will I take part?: 3 Months
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 19 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients who are treated in Haeundae Jaseng Korean Medicine Hospital

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

South Korea1 site

Haeundae Jaseng Hospital of Korean Medicine
Busan, 48102

Other trials in South Korea

About this study

Official title: Observational Study on Effectiveness of Megadose Shinbaro Pharmacopuncture for Patients With Chronic Shoulder Pain Due to the Shoulder Diseases

Read the 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).

Conditions: Shoulder Joint Disorder
Being tested: Megadose Shinbaro Pharmacopuncture
Keywords: Shoulder joints, Shinbaro pharmacopuncture, Megadose shinbaro pharmacopuncture, Chronic shoulder pain, Shoulder pain
Medical subject headings: Shoulder Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Megadose Shinbaro PharmacopunctureProcedure or surgery
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.

Study groups in NCT04222829
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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'.
Measured: At 2 weeks

Secondary outcomes (7)

Visual Analogue Scale of shoulder pain
VAS is an assessment index in which the patient records their pain on a 100mm line from 'no pain' at one end, and 'the most severe pain imaginable' at the other end. Higher scores mean a worse outcome
Measured: At screening, baseline, 2 weeks and through study completion, an average of 3 month
Shoulder mobility on the Shoulder ROM
Shoulder ROM was measured in six directions (Flexion, Extension, Abduction, Adduction, Right rotation, Left rotation) with goniometer.
Measured: At baseline, 2 weeks and through study completion, an average of 3 month
Shoulder Pain and Disability Index questionnaire of shoulder pain and disability
SPADI is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. Higher scores mean a worse outcome
Measured: At baseline, 2 weeks, 3 months
Patient Global Impression of Change
The PGIC is an index that assesses improvements in functional limitation caused by whiplash injury. Participants rate the improvement in functional limitations after treatment on a 7-point Likert scale (1=Very much improved, 4=No change, 7=Very much worse). This index was originally developed for use in Psychology, but is currently used in various other medical fields to assess improvements in pain.
Measured: At baseline, 2 weeks, 3 months
EuroQol 5-Dimension
The EQ-5D-5L is a method of indirectly calculating the weights of certain health states for quality of life after a multidimensional investigation of health states, and is the most widely used instrument for this purpose. The EQ-5D consists of 5 questions about current health state (mobility, self-care, usual activities, pain, anxiety/depression), and each question is scored on a 5-point Likert scale (1=no problems, 3=moderate problems, 5=severe problems). In this study, The investigators will use the Korean version of the EQ-5D-5L, which has been demonstrated to be valid.
Measured: At baseline, 2 weeks, 3 months
Number of Participants with Adverse events
Adverse events(AE) Physicians will monitor and record any unexpected or unintended patient reaction to integrative korean medicine at each visit. Adverse events (AEs) associated with integrative korean medicine will include, but not be limited to, AEs anticipated from previous reports of korean medicine, and will stay open to all possibilities taking into consideration other potential, unknown AEs.
Measured: Through study completion, an average of 3 month
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'.
Measured: At screening, baseline, 3 months and through study completion, an average of 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Dec 20191 Jun 2021

First posted10 Jan 2020
Study start4 Dec 2019
Primary completion1 Jun 2021
Study completion1 Jun 2021

Why it stopped: low participate rate

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Shoulder Joint DisorderStudies 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: Case-control
Time perspective: Prospective
Enrolment: 36 participants (actual)
Target duration: 3 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT04222829
Sponsor's protocol ID: JS-CT-2019-09
Status last verified: Aug 2022
First submitted: 7 Jan 2020
Last updated: 10 Aug 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Not yet recruiting
Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
Adhesive Capsulitis
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder

All Shoulder Joint Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Study on Effectiveness of Megadose Shinbaro Pharmacopuncture for Patients With Chronic Shoulder Pain Due to the Shoulder Diseases
ClinicalTrials.gov ID: NCT04222829
Acronym / sponsor ID: JS-CT-2019-09
Conditions: Shoulder Joint Disorder
Keywords: Shoulder joints, Shinbaro pharmacopuncture, Megadose shinbaro pharmacopuncture, Chronic shoulder pain, Shoulder pain
Study type: Observational
Recruitment status: TerminatedReason stopped: low participate rate
Enrolment: 36 participants (actual)
Lead sponsor: Jaseng Medical FoundationUniversity, hospital or other
Study start: 4 Dec 2019 (actual)
Primary completion: 1 Jun 2021 (actual)
Study completion: 1 Jun 2021 (actual)
First posted: 10 Jan 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.

Detailed description

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.

Study design

Observational model: Case-control
Time perspective: Prospective
Target follow-up: 3 Months
Number of arms: 2

Arm	Type	Receives
Megadose Shinbaro Pharmacopuncture Group	–	Procedure: Megadose Shinbaro PharmacopunctureThe 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.
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.

Who may qualify

Ages: 19 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients who are treated in Haeundae Jaseng Korean Medicine Hospital

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

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
Megadose Shinbaro PharmacopuncturePharmacopuncture 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.	Procedure or surgery	Megadose Shinbaro Pharmacopuncture Group

Primary outcome

Numeric Rating Scale of shoulder pain
Time frame: At 2 weeks
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'.

7 secondary outcomes

Visual Analogue Scale of shoulder pain
Time frame: At screening, baseline, 2 weeks and through study completion, an average of 3 month
Shoulder mobility on the Shoulder ROM
Time frame: At baseline, 2 weeks and through study completion, an average of 3 month
Shoulder Pain and Disability Index questionnaire of shoulder pain and disability
Time frame: At baseline, 2 weeks, 3 months
Patient Global Impression of Change
Time frame: At baseline, 2 weeks, 3 months
EuroQol 5-Dimension
Time frame: At baseline, 2 weeks, 3 months
Number of Participants with Adverse events
Time frame: Through study completion, an average of 3 month
Numeric Rating Scale of shoulder pain
Time frame: At screening, baseline, 3 months and through study completion, an average of 3 month

Results and safety

The study was stopped early (reason given: low participate rate). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
Individual participant dataSharing planned: Undecided

Related trials for Shoulder Joint Disorder

Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Not yet recruiting
Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
Adhesive Capsulitis
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder

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.

In-Hyuk Ha study chair

Jaseng Medical Foundation

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 Shoulder Joint Disorder, 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 10 Aug 2022. 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 was stopped early (reason given: low participate rate). Results are not available in the source record.

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?

Numeric Rating Scale of shoulder pain (time frame: At 2 weeks). 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 NCT04222829.

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 10 Aug 2022.