Clinical trial NCT00447876: Study to Assess the Efficacy and Safety of Dysport® in the Treatment of Chronic Plantar Fasciitis
Official title: Double-blind, Placebo-controlled, Randomised, Multicentre Study on the Efficacy and Safety of a Single Injection of Botulinum Toxin A (200 Units Dysport®) in the Treatment of Chronic Plantar Fasciitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Plantar Fasciitis
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2007-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the hypothesis that the analgesic effect of a single injection of Dysport (200 MU) induces a significant reduction of symptoms in chronic cases of plantar fasciitis.


Eligibility criteria: Inclusion Criteria:

* Chronic plantar fasciitis (duration of disorder at least 4 months)
* At least 4 points on the visual analogue scale (0-10) for the most severe pain within the last 48 hours
* At least 2 previous unsuccessful conservative therapies
* Age 18 and older

Exclusion Criteria:

* Rheumatoid diseases (M. Bechterew, chronic polyarthritis, psoriasis-arthritis, para /post-infectious arthritis etc.)
* Previous surgery in the affected area of the foot
* Pre-treatment with Botulinum toxin A (only de novo patients)
* Prohibited concomitant treatment: local injections during the study and 2 weeks prior to start of study

Primary outcomes:
measure: Responders Rate at Week 6 (Pain While Moving)
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Changes From Baseline in Gerbershagen's Score at Week 18
timeFrame: Baseline and Week 18
measure: Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit
timeFrame: Baseline and Weeks 2, 6, 10, 14 and 18
measure: Assessment of Sum of Pain Intensity Difference (SPID) for Maximum Pain for Overall Study
timeFrame: Baseline and Weeks 2, 6, 10, 14 and 18
measure: Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit
timeFrame: Baseline and Weeks 2, 6, 10, 14 and 18
measure: Assessment of SPID for Continuous Pain for Overall Study
timeFrame: Baseline and Weeks 2, 6, 10, 14 and 18
measure: Changes From Baseline in Pain Threshold at Each Visit
timeFrame: Baseline and Weeks 2, 6, 10, 14 and 18
measure: Assessment of Sum of Pain Threshold Differences (by Measurement of AUC) for Overall Study
timeFrame: Baseline and Weeks 2, 6, 10, 14 and 18
measure: Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit
timeFrame: Baseline and Weeks 2, 6, 10, 14 and 18
measure: Assessment of Sum of Pressure Threshold Differences (by Measurement of AUC) for Overall Study
timeFrame: Baseline and Weeks 2, 6, 10, 14 and 18
measure: Assessment of Dorsal Extension / Plantar Flexion Range of Motion (ROM) of the Affected Foot At Week 18
timeFrame: Baseline and Week 18
measure: Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit
timeFrame: Baseline and Weeks 2, 6, 10, 14 and 18
measure: Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit
timeFrame: Baseline and Weeks 2, 6, 10, 14 and 18
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: University Hospital Charite, Campus Virchow, Musculoskeletal Centre, Orthopedic Clinic
city: Berlin
country: Germany
facility: Orthopedic Practice Biberburg
city: Karlsruhe
country: Germany
facility: Orthopedic Practice
city: Marburg
country: Germany
facility: Klinik für Orthopädie und Rheumatologie, Universitätsklinikum Gießen und Marburg GmbH
city: Munich
country: Germany
facility: Orthocentre Munich
city: Weiden
country: Germany
facility: Orthopedic Practice
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: Peterlein CD, Funk JF, Holscher A, Schuh A, Placzek R. Is botulinum toxin A effective for the treatment of plantar fasciitis? Clin J Pain. 2012 Jul;28(6):527-33. doi: 10.1097/AJP.0b013e31823ae65a.