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

A Phase II Multicentre Multinational Prospective Randomised Double-blind Placebo-controlled Study Assessing the Efficacy and Safety of a Single Application of Three Doses of Dysport® in Patients With Upper Back Myofascial Pain Syndrome

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00134810

Enrollment

381

Registered

2005-08-25

Start date

2005-03-31

Completion date

2006-05-18

Last updated

2019-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myofascial Pain Syndromes

Keywords

Myofascial pain syndrome

Brief summary

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.

Interventions

BIOLOGICALBotulinum toxin type A

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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 pain score for 'worst pain of the day during activity' between baseline and Week 6	—
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	—
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	—

Countries

Czechia, Germany, Italy, Poland, Portugal, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026