Clinical trial NCT04173754: The Effectiveness of MSAT for Patients With ROM Limitation of the Shoulders
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Joint Disorder
Keywords: Shoulder joints
ROM
Shoulder disorder
MSAT
Motion Style Acupuncture Treatment
Shoulder pains
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are treated in Haeundae Jaseng Korean Medicine Hospital

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).

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

Primary outcomes:
measure: Shoulder mobility on the Shoulder ROM
timeFrame: At within 2 weeks
Secondary outcomes:
measure: Numeric Rating Scale(NRS) of shoulder pain
timeFrame: At screening, baseline, 2 weeks, 3 months, and through study completion, an average of 3 month
measure: Visual Analogue Scale (VAS) of shoulder pain
timeFrame: At screening, baseline, 2 weeks and through study completion, an average of 3 month
measure: Shoulder Pain and Disability Index(SPADI) questionnaire of shoulder pain and disability
timeFrame: At baseline, 2 weeks, 3 months
measure: Patient Global Impression of Change (PGIC)
timeFrame: At baseline, 2 weeks, 3 months
measure: EuroQol 5-Dimension (EQ-5D-5L)
timeFrame: At baseline, 2 weeks, 3 months
measure: Adverse events(AE)
timeFrame: Through study completion, an average of 3 month
measure: Shoulder mobility on the Shoulder ROM
timeFrame: At screening, baseline, 2 weeks, 3 months and through study completion, an average of 3 month
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Haeundae Jaseng Hospital of Korean Medicine
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha
role: STUDY_CHAIR
References: