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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-001443-29 | EudraCT Number |
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The main purpose of this study is to determine the effectiveness and safety of one dose of botulinum toxin type A (Dysport) associated with rehabilitation treatment on pain control in patients with a type of back pain called primary myofascial pain syndrome.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| The following parameters are measured at Inclusion, Week 2, Week 4, Week 8 and Week 12 of the study: | ||
| Pain evaluated by the Investigator through the determination of threshold of pain by pressure algometry for each trigger point. | ||
| Pain evaluated by the patient through a visual analog scale. | ||
| Evaluation of the Clinical Global Impressions of Change by the Investigator and by the patient. | ||
| Usual analgesic intake modification (on a daily basis by filling out a Patient's diary). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital "Vall d 'Hebrón". Barcelona | Barcelona | 08035 | Spain | |||
| University Hospital of Alcorcón |
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| ID | Term |
|---|---|
| D009209 | Myofascial Pain Syndromes |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Madrid |
| 28922 |
| Spain |
| Complexo Médico Quirúrgico del Conxo | Santiago de Compostela | 15706 | Spain |
| University Hospital "La Fe". Valencia | Valencia | 46009 | Spain |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |