Study to Assess the Efficacy and Safety of Dysport® in Upper Back Myofascial Pain Syndrome

Ipsen

Status and phase: Completed; Phase 2

Conditions: Myofascial Pain Syndromes

Treatments: Biological: Botulinum toxin type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00134810

2004-001845-13 (EudraCT Number)

Y-47-52120-722

Details and patient eligibility

About

The main purpose of this study is to determine which is the best dose of a drug known as Dysport to give when treating one's type of upper back pain. The study will also examine the side effects of this treatment and its overall effect on one's disorder.

Enrollment: 381 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate-severe pain in upper back
• Myofascial pain syndrome for more than 6 months
• Active trigger points in upper back

Exclusion criteria

• Fibromyalgia and other non-myofascial pain conditions of upper back
• Duration of myofascial pain syndrome no longer than 24 months
• Steroid injections during previous 3 months
• Anaesthetic injection at trigger points during previous 1 month

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind