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Completed

NCT Number: NCT04173754

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

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.

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Key information

Conditions

Shoulder Joint Disorder Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Haeundae Jaseng Hospital of Korean Medicine

Busan, 48102, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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'.

  2. Visual Analogue Scale (VAS) of shoulder pain

    Time frame: At screening, baseline, 2 weeks and through study completion, an average of 3 month

    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.

  3. Shoulder Pain and Disability Index(SPADI) questionnaire of shoulder pain and disability

    Time frame: At baseline, 2 weeks, 3 months

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

  4. Patient Global Impression of Change (PGIC)

    Time frame: At baseline, 2 weeks, 3 months

    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.

  5. EuroQol 5-Dimension (EQ-5D-5L)

    Time frame: At baseline, 2 weeks, 3 months

    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.

  6. Adverse events(AE)

    Time frame: Through study completion, an average of 3 month

    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.

  7. Shoulder mobility on the Shoulder ROM

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

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

Sponsors and collaborators

Lead sponsor

Jaseng Medical Foundation

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 22, 2019
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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