NCT00149240

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2006

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

1.1 years

First QC Date

September 7, 2005

Last Update Submit

November 21, 2019

Conditions

Myofascial Pain Syndromes

Keywords

DYSPORTbotulinum toxin Amyofascial pain syndrome

Outcome Measures

Primary Outcomes (5)

  • 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).

Interventions

Botulinum toxin type ABIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospital "Vall d 'Hebrón". Barcelona

Barcelona, 08035, Spain

Location

University Hospital of Alcorcón

Madrid, 28922, Spain

Location

Complexo Médico Quirúrgico del Conxo

Santiago de Compostela, 15706, Spain

Location

University Hospital "La Fe". Valencia

Valencia, 46009, Spain

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 8, 2005

Study Start

January 1, 2005

Primary Completion

February 2, 2006

Study Completion

February 2, 2006

Last Updated

November 22, 2019

Record last verified: 2019-11

Locations

ES(4)