Shoulder Joint DisorderNCT04173754

The Effectiveness of MSAT for Patients With ROM Limitation of the Shoulders

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is a prospective, case-control observational trial. The investigators will compare the MSAT group to the control group to analyze the effectiveness of shoulder MSAT. 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?: Motion Style Acupuncture Treatment(MSAT)
Type of treatment: Surgery or procedure
How many people: 80 participants
Where: 1 siteSouth Korea
Study dates: 4 Jul 2019to 1 Nov 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 more than one ROM limitation(Abduction 180˚, Adduction 45˚, Flexion 180˚, Extension 45˚, Int. rot 80˚, Ext. rot 80˚) on both or each shoulder.
Patients with NRS ≥ 4 for shoulder pain
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 ROM limitation of shoulder or 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 MSAT(Motion Style Acupuncture Treatment) for Patients With ROM(Range of Motion) Limitation of the Shoulders Due to the Shoulder Diseases

This study is a prospective, case-control observational trial. The investigators will compare the MSAT group to the control group to analyze the effectiveness of shoulder MSAT.

Read the detailed description

Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to move the part of their body actively during acupuncture treatment under physicians' observation. This treatment is known to relieve the pain and increase the range of motion(ROM). However, there has been no specific value for the effect of this treatment.

Therefore, The investigators conducted observational trial to analyze the effectiveness of shoulder MSAT. From July 2019, The investigators will collect 80 patients with ROM limitation on both or each shoulder and who are suffering from shoulder pain 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 MSAT and patients who are treated with Korean medical treatment not including MSAT.

For these two groups, The investigators will compare Range Of Motion(ROM), NRS(Numeric Rating Scale), Visual Analogue Scale(VAS), 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: Motion Style Acupuncture Treatment(MSAT)
Keywords: Shoulder joints, ROM, Shoulder disorder, MSAT, Motion Style Acupuncture Treatment, Shoulder pains
Medical subject headings: Shoulder Pain

What participants receive

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

Motion Style Acupuncture Treatment(MSAT)Procedure or surgery
Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to move the part of their body actively during acupuncture treatment under physicians' observation

Study groups in NCT04173754
Study group	Role	What they receive
MSAT Group		The MSAT group who are treated with korean medical treatment including MSAT 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, pharmaco-acupuncture and Korean herbal medicine. Receives: Procedure: Motion Style Acupuncture Treatment(MSAT)
Control Group		The control group who are treated with Korean medical treatment not including MSAT 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, pharmaco-acupuncture and Korean herbal medicine.

What is being measured

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

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 within 2 weeks

Secondary outcomes (7)

Numeric Rating Scale(NRS) 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, 2 weeks, 3 months, and through study completion, an average of 3 month
Visual Analogue Scale (VAS) 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.
Measured: At screening, baseline, 2 weeks and through study completion, an average of 3 month
Shoulder Pain and Disability Index(SPADI) 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.
Measured: At baseline, 2 weeks, 3 months
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: At baseline, 2 weeks, 3 months
EuroQol 5-Dimension (EQ-5D-5L)
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
Adverse events(AE)
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
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 screening, baseline, 2 weeks, 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 Jul 20191 Nov 2021

First posted22 Nov 2019
Study start4 Jul 2019
Primary completion30 Jul 2021
Study completion1 Nov 2021

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: 80 participants (actual)
Target duration: 3 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT04173754
Sponsor's protocol ID: JS-CT-2019-10
Status last verified: Aug 2022
First submitted: 14 Nov 2019
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 MSAT(Motion Style Acupuncture Treatment) for Patients With ROM(Range of Motion) Limitation of the Shoulders Due to the Shoulder Diseases
ClinicalTrials.gov ID: NCT04173754
Acronym / sponsor ID: JS-CT-2019-10
Conditions: Shoulder Joint Disorder
Keywords: Shoulder joints, ROM, Shoulder disorder, MSAT, Motion Style Acupuncture Treatment, Shoulder pains
Study type: Observational
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Jaseng Medical FoundationUniversity, hospital or other
Study start: 4 Jul 2019 (actual)
Primary completion: 30 Jul 2021 (actual)
Study completion: 1 Nov 2021 (actual)
First posted: 22 Nov 2019 (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 prospective, case-control observational trial. The investigators will compare the MSAT group to the control group to analyze the effectiveness of shoulder MSAT.

Detailed description

Study design

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

Arm	Type	Receives
MSAT Group	–	Procedure: Motion Style Acupuncture Treatment(MSAT)The MSAT group who are treated with korean medical treatment including MSAT 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, pharmaco-acupuncture and Korean herbal medicine.
Control Group	–	–The control group who are treated with Korean medical treatment not including MSAT 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, pharmaco-acupuncture 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 (4 listed)

Patients with more than one ROM limitation(Abduction 180˚, Adduction 45˚, Flexion 180˚, Extension 45˚, Int. rot 80˚, Ext. rot 80˚) on both or each shoulder.
Patients with NRS ≥ 4 for shoulder pain
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 ROM limitation of shoulder or 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
Motion Style Acupuncture Treatment(MSAT)Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to move the part of their body actively during acupuncture treatment under physicians' observation	Procedure or surgery	MSAT Group

Primary outcome

Shoulder mobility on the Shoulder ROM
Time frame: At within 2 weeks
Shoulder ROM was measured in six directions (Flexion, Extension, Abduction, Adduction, Right rotation, Left rotation) with goniometer.

7 secondary outcomes

Numeric Rating Scale(NRS) of shoulder pain
Time frame: At screening, baseline, 2 weeks, 3 months, and through study completion, an average of 3 month
Visual Analogue Scale (VAS) of shoulder pain
Time frame: At screening, baseline, 2 weeks and through study completion, an average of 3 month
Shoulder Pain and Disability Index(SPADI) questionnaire of shoulder pain and disability
Time frame: At baseline, 2 weeks, 3 months
Patient Global Impression of Change (PGIC)
Time frame: At baseline, 2 weeks, 3 months
EuroQol 5-Dimension (EQ-5D-5L)
Time frame: At baseline, 2 weeks, 3 months
Adverse events(AE)
Time frame: Through study completion, an average of 3 month
Shoulder mobility on the Shoulder ROM
Time frame: At screening, baseline, 2 weeks, 3 months and through study completion, an average of 3 month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 4 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Shoulder mobility on the Shoulder ROM (time frame: At within 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 NCT04173754.

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.