Botulinum Toxin Type A (Dysport) Associated With Rehabilitation Treatment in Patients With Primary Myofascial Pain Syndrome
This study has been completed.
Information provided by:
First received: September 7, 2005
Last updated: April 17, 2007
Last verified: April 2007
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.
Myofascial Pain Syndromes
Drug: Botulinum toxin type A (Dysport)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||A Phase II, Multicentre, Randomised, Double-Blind, Parallel and Controlled With Placebo Pilot Study to Evaluate the Efficacy and Safety of a Single Dose of Botulinum Toxin Type A (Dysport) Associated With Rehabilitation Treatment, in Patients With Primary Myofascial Syndrome of Cervical and Dorsal Localisation
Primary Outcome Measures:
- 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).
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients with primary myofascial pain syndrome of cervical and dorsal localization, less than two years of length, who must have been diagnosed with the evidence of "trigger points" in which conventional treatment with oral analgesia, rehabilitation and local anesthesia has not been clinically successful for more than 15 days.
- Punctuation of 4cm or more in a 10cm visual analog scale.
- Previous positive response (self-limited reduction -less than 15 days- of pain) after an anaesthetic infiltration in the trigger point.
- Patients diagnosed with fibromyalgia or with a spread pain.
- Patients having received previously botulinum toxin.
- Patients having received anesthetic injections at the trigger points within the month before the visit.
- Patients having received corticosteroids injections at the trigger points within three months before the selection visit.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149240
|University Hospital "Vall d 'Hebrón". Barcelona
|Barcelona, Spain, 08035 |
|University Hospital of Alcorcón
|Madrid, Spain, 28922 |
|Complexo Médico Quirúrgico del Conxo
|Santiago de Compostela, Spain, 15706 |
|University Hospital "La Fe". Valencia
|Valencia, Spain, 46009 |
||Mónica de Abadal, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 7, 2005
||April 17, 2007
||Spain: Ministry of Health
Keywords provided by Ipsen:
botulinum toxin A
myofascial pain syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 21, 2014
Myofascial Pain Syndromes
Nervous System Diseases
Botulinum Toxins, Type A
Central Nervous System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs