Clinical trial to evaluate the efficacy and safety of massage using a CMP-100 medical device in patients with shoulder-back myofascial pain syndrom

Not Applicable

• Conditions: Diseases of the musculo-skeletal system and connective tissue

• Registration Number: KCT0003971
• Lead Sponsor: Wonkwang University, Gwangju Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 June 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Adults over 19 years
2. Person with more than 100mm VAS(Visual analogue scale) 40mm (sholder-back pain)
3. A person whose threshold of pressure pain is less than or equal to 2.0?/? in trigger points
4. Person diagnosed myofascial pain syndrome
5. Those who have heard the full explanation of this human application test, fully understand it, and have voluntarily decided to participate and have agreed in writing to comply with the precautions.

Exclusion Criteria

1. Person with past history of cervical, shoulder-back, lumbar trauma or operation(within the last 6 months)
2. Patients with chronic pain diseases including back pain
3. People with burns, tattoos, subcutaneous bleeding, or severe skin conditions requiring clinically treatment
4. People with mental illness that may affect the test
5. Subjects with hypersensitivity to electrical stimulation
6. Infants, pregnant women, lactating women, or those planning a pregnancy during the clinical trial
7. Those who have participated in other clinical trials since enrolling in this trial. or Those who participated in a clinical trial involving a shoulder or back pain before enrolling in this trial(within 3 months)
8. Hypertension, a person using an electronic medical device (eg, pacemaker etc.) attached to a human body
9. Those who are considered to be difficult to perform the trial under the judgment of principal investigator

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
100mm VAS(visual analog scale)

Secondary Outcome Measures

Name	Time	Method
Threshold of pressure pain;AROM(active range of motion) of cervical lateral flexion;shoulder mobility;SPADI(Shoulder pain and disability index);Adverse events;Laboratory test value;Vital sign;EKG(Electrocardiogram)