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

Ipsen381 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

381

Conditions

Myofascial Pain Syndromes

Interventions

Botulinum toxin type ABIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (22)

Pain Treatment Centre, Anesthesiology & Resuscitation, St Ann Teaching Hospital

Brno, Czechia

Outcomes

Primary Outcomes

Change in pain score for 'overall pain of the day during activity' between baseline and Week 6

Secondary Outcomes

Change in pain score for 'worst pain of the day during activity' between baseline and Week 6

Change in pain score for 'overall pain of the day at rest' between baseline and Week 6

Spontaneously reported adverse events and changes in physical examination and vital signs

Change in pain score for 'overall pain during activity' between baseline and Weeks 6, 12 and 16

Time to onset of pain relief

Change in each of the 8 dimensions of the Short Form Quality of Life questionnaire with 36 items (SF36) at Weeks 6, 12 and 16 from baseline

Change in the Hospital Anxiety and Depression Scale (HADS) anxiety score, depression score and aggregate score at Weeks 6, 12 and 16 from baseline

Clinical Global Impression of Change (CGIC) assessed using a 7-point numerical rating scale at Week 16

Patient's Global Impression of Change (PGIC) assessed using a 7-point numerical rating scale at Week 16

Data from ClinicalTrials.gov

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