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

NCT ID: NCT04173754

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-04
• Study Completion Date: 2021-11-01

Brief 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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

Motion Style Acupuncture Treatment(MSAT)

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jaseng Medical Foundation

OTHER

Sponsor Role: lead

Responsible Party

In-Hyuk Ha, KMD

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

In-Hyuk Ha

Role: STUDY_CHAIR

Jaseng Medical Foundation

Locations

Haeundae Jaseng Hospital of Korean Medicine

Busan, , South Korea

Countries

South Korea

Other Identifiers

JS-CT-2019-10

Identifier Type: -

Identifier Source: org_study_id