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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003971

Enrollment

Registered

2019-05-22

Start date

2019-11-30

Completion date

Unknown

Last updated

2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : 1. Number of treatments(common): total 8 times (twice a week/treatment for 4weeks) 2. Time of treaments(common): total 30 minumues (electric therapy: 15 minumues / massage using a CM

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
100mm VAS(visual analog scale)	—

Secondary

Measure	Time frame
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)	—

Countries

Korea, Republic of

Contacts

Public ContactYoung Kwon

Wonkwang University, Gwangju Medical Center

exeterin@naver.com+82-62-670-6452

Outcome results