Clinical study on efficacy and safety of polydioxanone thread procedure for myofascial pain syndrome in the trapezius muscle
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0005359
- Lead Sponsor
- The Catholic University of Korea, Incheon St. Mary's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
(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
(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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method