Acute Shoulder PainShoulder chunaNCT06624800
The Efficacy and Safety of Shoulder Chuna on in Patients With Shoulder Pain Caused by Traffic Accidents
A study testing Shoulder chuna treatment(posterior displacement, anterior displacement, or lateral displacement) and Korean medical treatment in people with Acute Shoulder Pain, run by Jaseng Medical Foundation at 1 site in South Korea.
Trial summary
This study is a double blind, randomized controlled trail. condition/disease: Patient with acute shoulder pain and restricted movement due to a traffic accident. treatment/intervention: Chuna therapy for the shoulder, including integrated Korean medicine treatment Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Acute Shoulder Pain
- What is being tested?
- Shoulder chuna treatment(posterior displacement, anterior displacement, or lateral displacement) and Korean medical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Nov 2024to 10 Nov 2025
- Phase
- Interventional
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 19-69 years on the date they sign the consent form.
- Patients with shoulder pain and restricted movement occurring within 5 days after a traffic accident.
- Patients who are hospitalized due to traffic accident.
- Patients with NRS of shoulder pain ≥ 5 with restricted movement due to a traffic accident.
- Patients who provide consent to participate in the trial and return the informed consent form.
Who cannot join
- Patients with a specific serious disease that may cause shoulder pain: malignancy, spondylitis, inflammatory spondylitis, etc.
- Patients with progressive neurological deficits or with severe neurological symptoms.
- Patients with medical history of cervical surgery or shoulder surgery within the last three weeks.
- Patients with a specific serious disease that may interfere with the interpretation of the therapeutic effects or results: malignancy, spondylitis, inflammatory spondylitis, etc.
- Chuna therapy is deemed inappropriate or unsafe due to conditions like fractures, dislocations, ligament tears, or unstable healing fractures; skeletal demineralization and ligament laxity with subluxation or dislocation; or inflammation
- Presence of other chronic diseases that could interfere with treatment outcomes or interpretation, such as cardiovascular disease, kidney disease, diabetic neuropathy, dementia, or epilepsy
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- Currently taking steroids, immunosuppressants, psychiatric medications, or other drugs that may affect study results
- Acupuncture is deemed inappropriate or unsafe, such as in patients with bleeding disorders, those on anticoagulant therapy, those with severe diabetes prone to infection, or those with severe cardiovascular disease
- Patients who are pregnant or planning to become pregnant.
- Patients who are presence of severe mental illness
- Patients who are participated in clinical trials other than observational studies without therapeutic intervention.
- Patients who are difficult to complete the research participation agreement.
- Other patients whose participation in the trial is judged by a researcher to be problematic.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 135-896
About this study
Official title: The Efficacy and Safety of Shoulder Chuna on in Patients With Shoulder Pain Caused by Traffic Accidents: A Pragmatic Randomized Controlled Trial
This study is a double blind, randomized controlled trail. condition/disease: Patient with acute shoulder pain and restricted movement due to a traffic accident. treatment/intervention: Chuna therapy for the shoulder, including integrated Korean medicine treatment
Read the detailed description
The investigators intend to conduct a randomized controlled trial to evaluate the effectiveness of Chuna therapy for shoulder pain and restricted movement caused by a traffic accident. The study will involve administering shoulder Chuna therapy from the second day of hospitalization until discharge, with the aim of assessing its effects on shoulder pain relief and recovery of range of motion. Although the effectiveness of Korean medicine for treating trauma from traffic accidents has been well studied, the research has largely focused on spinal conditions, such as those affecting the cervical and lumbar spine. Likewise, most studies on Chuna therapy have centered around spinal disorders. Through this study, the investigators aim to explore the therapeutic effects of shoulder Chuna therapy, an area that has not been extensively researched.
- The effectiveness of shoulder Chuna therapy will be evaluated by observing and comparing changes in pain, range of motion limitation, functional disability, quality of life, and patient satisfaction between the shoulder Chuna group (treatment group) and the Korean integrative medicine group (control group).
- Investigators will assess the treatment effects of shoulder Chuna therapy on shoulder pain and restricted movement by observing improvements in initial NRS, VAS scores, SPADI, and ROM in the shoulder Chuna group (treatment group) compared to the Korean integrative medicine group (control group).
- The total number of treatment sessions and the degree of improvement will be observed and compared between the shoulder Chuna group (treatment group) and the Korean integrative medicine group (control group) to evaluate the effectiveness of the treatment frequency.
- The safety of the therapy will be assessed by investigating adverse reactions in both the shoulder Chuna group (treatment group) and the Korean integrative medicine group (control group).
- Conditions
- Acute Shoulder Pain
- Being tested
- Shoulder chuna treatment(posterior displacement, anterior displacement, or lateral displacement), Korean medical treatment
- Keywords
- shoulder chuna therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder chuna treatment(posterior displacement, anterior displacement, or lateral displacement)Procedure or surgery
The Shoulder Chuna therapy for the shoulder joint will be performed on the affected shoulder from the second day of hospitalization until the day before discharge.
Korean medical treatmentProcedure or surgery
acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine
| Study group | Role | What they receive |
|---|---|---|
| Shoulder chuna treatment | Experimental | During the hospitalization period, Chuna therapy for the shoulder joint will be performed once a day for a total of 10 to 15 minutes, including before, during, and after the treatment. The practitioner will assess the condition and select one of three techniques-posterior displacement, anterior displacement, or lateral displacement-to apply Chuna therapy Receives: Procedure: Korean medical treatment |
| Korean medical treatment | Active comparator | The control group were received Korean medical treatment everyday after hospitalization: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine. Receives: Procedure: Shoulder chuna treatment(posterior displacement, anterior displacement, or lateral displacement); Procedure: Korean medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale(NRS) of Shoulder pain
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: Screening, From baseline(Day2) up to Discharge 1 day, 2week after enrollment, 1month after enrollment, 3month after enrollment
Secondary outcomes (6)
Location of shoulder joint displacement
The location of shoulder pain varies depending on the nerve. The assessor will ask patients where the pain occur.
Measured: Screening, From baseline(Day2) up to Discharge 1 day, 2week after enrollment, 1month after enrollment, 3month after enrollment
Shoulder Pain intensity scale: Visual Analogue Scale (VAS)
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.
Measured: From baseline(Day2) up to Discharge 1 day
Physical examination (Shoulder active range of motion)
The patient\'s maximum active and passive range of motion (ROM) of the shoulder, which they can move without pain, will be measured. The shoulder ROM will include six movements: flexion, extension, adduction, abduction, internal rotation, and external rotation. Measurements will be taken before and after treatment using a goniometer. If the patient refuses the measurement due to severe pain or other reasons, a value of 0 degrees will be recorded.
Measured: From baseline(Day2) up to Discharge 1 day
Shoulder Pain and Disability Index(SPADI)
The patient\'s functional status will be assessed using the SPADI questionnaire. The SPADI was developed to evaluate the degree of disability related to shoulder pain and consists of 13 items in total: 5 items on the severity of pain and 8 items on the degree of discomfort. Each item is rated on a 10-point scale, with scores ranging from 0 to 10. Higher scores indicate greater disability. A validated Korean version of the SPADI questionnaire will be used.
Measured: From baseline(Day2) up to Discharge 1 day, 2week after enrollment, 1month after enrollment, 3month after enrollment
EuroQol 5-Dimension (EQ-5D)
The EQ-5D 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, which has been demonstrated to be valid.
Measured: From baseline(Day2) up to Discharge 1 day, 2week after enrollment, 1month after enrollment, 3month after enrollment
Patient Global Impression of Change (PGIC)
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: Discharge 1 day, 2week after enrollment, 1month after enrollment, 3month after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start4 Nov 2024
- Primary completion5 Jul 2025
- Study completion10 Nov 2025
Why it stopped: The patient completed the follow-up (FU), and the study was concluded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Shoulder PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- In-Hyuk Ha, phD, Study director, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624800
- Sponsor's protocol ID
- JS-CT-2024-08
- Other IDs
- Jaseng Medical Foundation
- Acronym
- Shoulder chuna
- Status last verified
- Mar 2026
- First submitted
- 26 Sep 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Shoulder Chuna on in Patients With Shoulder Pain Caused by Traffic Accidents: A Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06624800
- Acronym / sponsor ID
- Shoulder chuna / JS-CT-2024-08
- Conditions
- Acute Shoulder Pain
- Keywords
- shoulder chuna therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The patient completed the follow-up (FU), and the study was concluded.
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 5 Jul 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 3 Oct 2024 (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.
This study is a double blind, randomized controlled trail. condition/disease: Patient with acute shoulder pain and restricted movement due to a traffic accident. treatment/intervention: Chuna therapy for the shoulder, including integrated Korean medicine treatment
Detailed description
The investigators intend to conduct a randomized controlled trial to evaluate the effectiveness of Chuna therapy for shoulder pain and restricted movement caused by a traffic accident. The study will involve administering shoulder Chuna therapy from the second day of hospitalization until discharge, with the aim of assessing its effects on shoulder pain relief and recovery of range of motion. Although the effectiveness of Korean medicine for treating trauma from traffic accidents has been well studied, the research has largely focused on spinal conditions, such as those affecting the cervical and lumbar spine. Likewise, most studies on Chuna therapy have centered around spinal disorders. Through this study, the investigators aim to explore the therapeutic effects of shoulder Chuna therapy, an area that has not been extensively researched.
- The effectiveness of shoulder Chuna therapy will be evaluated by observing and comparing changes in pain, range of motion limitation, functional disability, quality of life, and patient satisfaction between the shoulder Chuna group (treatment group) and the Korean integrative medicine group (control group).
- Investigators will assess the treatment effects of shoulder Chuna therapy on shoulder pain and restricted movement by observing improvements in initial NRS, VAS scores, SPADI, and ROM in the shoulder Chuna group (treatment group) compared to the Korean integrative medicine group (control group).
- The total number of treatment sessions and the degree of improvement will be observed and compared between the shoulder Chuna group (treatment group) and the Korean integrative medicine group (control group) to evaluate the effectiveness of the treatment frequency.
- The safety of the therapy will be assessed by investigating adverse reactions in both the shoulder Chuna group (treatment group) and the Korean integrative medicine group (control group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shoulder chuna treatment | Experimental | Procedure: Korean medical treatmentDuring the hospitalization period, Chuna therapy for the shoulder joint will be performed once a day for a total of 10 to 15 minutes, including before, during, and after the treatment. The practitioner will assess the condition and select one of three techniques-posterior displacement, anterior displacement, or lateral displacement-to apply Chuna therapy |
| Korean medical treatment | Active comparator | Procedure: Shoulder chuna treatment(posterior displacement, anterior displacement, or lateral displacement), Procedure: Korean medical treatmentThe control group were received Korean medical treatment everyday after hospitalization: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine. |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 19-69 years on the date they sign the consent form.
- Patients with shoulder pain and restricted movement occurring within 5 days after a traffic accident.
- Patients who are hospitalized due to traffic accident.
- Patients with NRS of shoulder pain ≥ 5 with restricted movement due to a traffic accident.
- Patients who provide consent to participate in the trial and return the informed consent form.
Key exclusion criteria (13 listed)
- Patients with a specific serious disease that may cause shoulder pain: malignancy, spondylitis, inflammatory spondylitis, etc.
- Patients with progressive neurological deficits or with severe neurological symptoms.
- Patients with medical history of cervical surgery or shoulder surgery within the last three weeks.
- Patients with a specific serious disease that may interfere with the interpretation of the therapeutic effects or results: malignancy, spondylitis, inflammatory spondylitis, etc.
- Chuna therapy is deemed inappropriate or unsafe due to conditions like fractures, dislocations, ligament tears, or unstable healing fractures; skeletal demineralization and ligament laxity with subluxation or dislocation; or inflammation
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 |
|---|---|---|
| Shoulder chuna treatment(posterior displacement, anterior displacement, or lateral displacement)The Shoulder Chuna therapy for the shoulder joint will be performed on the affected shoulder from the second day of hospitalization until the day before discharge. | Procedure or surgery | Korean medical treatment |
| Korean medical treatmentacupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine | Procedure or surgery | Korean medical treatment, Shoulder chuna treatment |
Primary outcome
Numeric Rating Scale(NRS) of Shoulder pain
Time frame: Screening, From baseline(Day2) up to Discharge 1 day, 2week after enrollment, 1month after enrollment, 3month after enrollment
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\'.
6 secondary outcomes
Location of shoulder joint displacement
Time frame: Screening, From baseline(Day2) up to Discharge 1 day, 2week after enrollment, 1month after enrollment, 3month after enrollment
Shoulder Pain intensity scale: Visual Analogue Scale (VAS)
Time frame: From baseline(Day2) up to Discharge 1 day
Physical examination (Shoulder active range of motion)
Time frame: From baseline(Day2) up to Discharge 1 day
Shoulder Pain and Disability Index(SPADI)
Time frame: From baseline(Day2) up to Discharge 1 day, 2week after enrollment, 1month after enrollment, 3month after enrollment
EuroQol 5-Dimension (EQ-5D)
Time frame: From baseline(Day2) up to Discharge 1 day, 2week after enrollment, 1month after enrollment, 3month after enrollment
Patient Global Impression of Change (PGIC)
Time frame: Discharge 1 day, 2week after enrollment, 1month after enrollment, 3month after enrollment
Results and safety
The study was stopped early (reason given: The patient completed the follow-up (FU), and the study was concluded.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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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, phD study director
Jaseng Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shoulder chuna treatment(posterior displacement, anterior displacement, or lateral displacement) and Korean medical treatment in people with Acute Shoulder Pain, 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 5 inclusion and 13 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 27 Mar 2026. 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: The patient completed the follow-up (FU), and the study was concluded.). 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(NRS) of Shoulder pain (time frame: Screening, From baseline(Day2) up to Discharge 1 day, 2week after enrollment, 1month after enrollment, 3month after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2026.