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

Jaseng Medical Foundation80 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Shoulder Joint Disorder

Interventions

Motion Style Acupuncture Treatment(MSAT)PROCEDURE

Eligibility

Sex: ALLMin age: 19 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Haeundae Jaseng Hospital of Korean Medicine

Busan, South Korea

Outcomes

Primary Outcomes

Shoulder mobility on the Shoulder ROM

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

Time frame: At within 2 weeks

Secondary Outcomes

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'.

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

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.

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

SPADI is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities.

Time frame: 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.

Data from ClinicalTrials.gov

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