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

NCT04173754 | Completed

• 1 other identifier: JS-CT-2019-10
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Joint Disorder

Keywords

Shoulder joints; ROM; Shoulder disorder; MSAT; Motion Style Acupuncture Treatment; Shoulder pains

Outcome Measures

Primary Outcomes (1)

• Shoulder mobility on the Shoulder ROM

  Shoulder ROM was measured in six directions (Flexion, Extension, Abduction, Adduction, Right rotation, Left rotation) with goniometer.

  At within 2 weeks

Secondary Outcomes (7)

• Numeric Rating Scale(NRS) of shoulder pain

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

• Visual Analogue Scale (VAS) of shoulder pain

  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

  At baseline, 2 weeks, 3 months

• Patient Global Impression of Change (PGIC)

  At baseline, 2 weeks, 3 months

• EuroQol 5-Dimension (EQ-5D-5L)

  At baseline, 2 weeks, 3 months

Study Arms (2)

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.

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.

Interventions

Motion Style Acupuncture Treatment(MSAT) 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

MSAT 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 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

You may not qualify if:

• 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

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: November 14, 2019
• First Posted: November 22, 2019
• Study Start: July 4, 2019
• Primary Completion: July 30, 2021
• Study Completion: November 1, 2021
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

KR (1)