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Clinical study on efficacy and safety of polydioxanone thread procedure for myofascial pain syndrome in the trapezius muscle

Clinical study on efficacy and safety of polydioxanone thread procedure for myofascial pain syndrome in the trapezius muscle: a single center, randomized, double-blinded, case-control trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CRIS
Registry ID
KCT0005359
Enrollment
30
Registered
2020-09-01
Start date
2021-05-04
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

None listed

Interventions

Procedure/Surgery : According to the Travell and Simons criteria of MPS, the trigger points which cause pain of MPS are diagnosed with clinical examination. The procedure is performed at the point o

Sponsors

The Catholic University of Korea, Incheon St. Mary's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime frame
Evaluation of effectiveness - NRS and NDI are used for the evaluation of effectiveness.

Countries

Korea, Republic of

Contacts

Public ContactJaewon Kim

The Catholic University of Korea, Incheon St. Mary's Hospital

jw2356@hanmail.net+82-32-280-6601

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 7, 2026