None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Male or female subjects no younger than 20 years and no older than 70 years (2) diagnosed as myofascial pain of the neck and shoulders of at least 3 years duration and need treatment (3) failed or insufficient effects of standard therapy (i.e., physical modality, exercise, medication and trigger point injections) (4) pain scale score of 4 or higher (5) voluntary informed consent signed by the patient after the objectives and methods of the clinical study has been explained. (6) can visit for the close follow up
Exclusion criteria
Exclusion criteria: (1) patients with a history of allergy or sensitivity to polydioxanone or metal. (2) patients diagnosed as fibromyalgia (3) patients got injection within two months (4) patients diagnosed with cervical radiculopathy, spinal cord disease, severe herniated cervical nucleus pulposus, straight neck syndrome, or cervical sprain (5) patients diagnosed with motor neuron disease, neuromuscular junction disease, or severe musculoskeletal lesions (6) patients who have undergone surgery on the cervical vertebrae and shoulder girdle within a year. (7) patients taking anti-platelet drug (8) patients suffering from severe heart disease, respiratory disease, systemic infection, and inflammatory disease. (9) subjects participated in other clinical trial within 3 months (10) patients who have severe cognitive dysfunction (11) patients diagnosed with major depression disorder (12) patients reluctant to cooperative in evaluation, treatment, and follow-up (13) subjects who are pregnant or breastfeeding (14) subjects who do not want to participate in this trial. (15) subjects thought to be inappropriate to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain improvement in the experimental group is compared with the control group. The improvement of pain is defined as improvement of 30% or more of the Numerical Rating Scale (NRS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of effectiveness - NRS and NDI are used for the evaluation of effectiveness. | — |
Countries
Korea, Republic of
Contacts
The Catholic University of Korea, Incheon St. Mary's Hospital