None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : Nabota(botulinum toxin A) is injected in the muscle of presence of trigger point.
A maximum of 200 units was injected in any subject.
Sponsors
The Catholic University of Korea, Incheon St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female subjects no younger than 20 years of age. 2) Myofascial pain of the neck and shoulders of at least 3 months duration 3) Have failed standard therapy (physical modality, exercise, medication, trigger point injection except for botulinum toxin A) 4) Numerical rating scale pain score 5 or higher 5) Voluntary informed consent signed by patient after objective, methods, and efficacy of clinical study have been explained
Exclusion criteria
Exclusion criteria: 1) Patients who have a history of Neuromuscular disease (Ex, Myasthenia Gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, motor neuron disease) 2) Patients with prior botulinum toxin A therapy within 4 months 3) Patients with known allergy or sensitivity to any component of the test medication (botulinum toxin A, humen serum albumin, sodium chloride) 4) Pregnancy or breastfeeding women 5) Patients with significant atrophy of the muscle in the target areas of injection 6) Patient with weakness of muscles in the target area (Medical Research Council(MRC) < 5) 7) Inappropriate subjects for entry into this study in the judgement of the investigator 8) Patients who are taking drugs with muscle relaxing action within the previous 4 weeks of the screening visit. 9) Patients who are taking aspirin, nonsteroidal anti-inflammatory drugs, or antiplatelet drugs 10) Patients with other active illness 11) Patients with moderate degree of cardiac disease or pulmonary disease 12) Patients with cervical herniated nucleus pulposus, straight cervical spine, or cervical sprain 13) Patients have participated in an investigational drug study or bioequivalence study within the previous 3 months of the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the percentage of patients whose pain scores (numerical rating scale) improved by 30% or more at 12 weeks from the injection. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement pain scale;Improvement neck disability index;Laboratory Tests;Vital Signs (Blood pressure, and pulse) | — |
Countries
Korea, Republic of
Contacts
Public ContactJaemin Kim
The Catholic University of Korea, Incheon St. Mary's Hospital
Outcome results
None listed