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Study to Assess the Efficacy and Safety of Dysport® in the Treatment of Chronic Plantar Fasciitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00447876
First received: March 13, 2007
Last updated: April 6, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Chronic Plantar Fasciitis Drug: Botulinum type A toxin (Dysport®) Other: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Responders Rate at Week 6 (Pain While Moving) [ Time Frame: Baseline and Week 6 ]
    The responder rate was defined as the percentage of patients whose pain score while moving during the last 48 hours, measured by means of a 10 cm Visual Analogue Scale (VAS, 0 = no pain, 10 = maximum pain) decreased by at least 50% at Week 6 as compared to baseline. Pain at movement is the cardinal symptom of plantar fasciitis and the 10 cm VAS is a reference method for the assessment of pain intensity.


Secondary Outcome Measures:
  • Changes From Baseline in Gerbershagen's Score at Week 18 [ Time Frame: Baseline and Week 18 ]
    The Gerbershagen scale gives a global score ranging between I and III, with lower scores reflecting less impact of pain in terms of temporal, spatial aspects, drug taking behaviour and utilization of the health care system. The changes in Gerbershagen's global scores from baseline to Week 18 are reported as percentage of patients for each of the specified categories.

  • Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
    Assessments of the pain intensity while moving (maximum pain during the previous 48 hours) were performed by means of a 10 cm VAS (0 = no pain, 10 = maximum pain) at each visit. The changes from baseline, expressed as Pain Intensity Difference (PID) values at each indicated timepoint are reported.

  • Assessment of Sum of Pain Intensity Difference (SPID) for Maximum Pain for Overall Study [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
    Assessments of the pain intensity while moving (maximum pain during the previous 48 hours) were performed by means of a 10 cm VAS (0 = no pain, 10 = maximum pain) at each visit. The PID values at each timepoint were determined by comparison to baseline, followed by calculation of the area under the curve (AUC) of PID as a function of time (i.e. SPID). The least square (LS) means of SPID, adjusted for the baseline value of pain while moving are reported.

  • Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
    Assessments of the pain intensity while at rest (continuous pain during the previous 48 hours) were performed by means of a 10 cm VAS (0 = no pain, 10 = maximum pain) at each visit. The changes from baseline, expressed as PID values at each indicated timepoint are reported.

  • Assessment of SPID for Continuous Pain for Overall Study [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
    Assessments of the pain intensity while at rest (continuous pain during the previous 48 hours) were performed by means of a 10 cm VAS (0 = no pain, 10 = maximum pain) at each visit. The PID values at each timepoint were determined by comparison to baseline, followed by calculation of the AUC of PID as a function of time (i.e. SPID). The LS means for SPID, adjusted for the baseline value of pain at rest are reported.

  • Changes From Baseline in Pain Threshold at Each Visit [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
    The maximum pain felt in the medial back foot was measured using an algometer. The pain threshold corresponded to the maximum pressure at which pain was still tolerated. Changes from baseline, expressed as pain threshold differences at each indicated timepoint are reported.

  • Assessment of Sum of Pain Threshold Differences (by Measurement of AUC) for Overall Study [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
    Assessments of the pain threshold using an algometer (which was the pressure corresponding to the maximum tolerated pain) were performed at each visit. Pain threshold differences at each timepoint were determined by comparison to baseline, followed by calculation of the AUC of the pain threshold difference as a function of time. The LS means of AUC, adjusted for the baseline value of pain threshold are reported.

  • Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
    Pressure pain in the medial back foot was measured using an algometer. Pressure threshold corresponded to the minimum pressure causing pain. The changes from baseline, expressed as pressure threshold differences at each indicated timepoint are reported.

  • Assessment of Sum of Pressure Threshold Differences (by Measurement of AUC) for Overall Study [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
    Assessments of the pressure threshold using an algometer (which corresponded to the minimum pressure causing pain) were performed at each visit. Pressure threshold differences at each timepoint were determined by comparison to baseline, followed by calculation of the AUC of the pressure threshold difference as a function of time. The LS means of AUC, adjusted for the baseline value of pressure threshold are reported.

  • Assessment of Dorsal Extension / Plantar Flexion Range of Motion (ROM) of the Affected Foot At Week 18 [ Time Frame: Baseline and Week 18 ]
    Dorsal extension and plantar flexion of the affected foot were assessed at baseline and at Week 18. A ROM of approximately 70 degrees is considered to be normal. The LS means, adjusted for the baseline value are reported.

  • Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
    A global assessment of the patient's current condition relative to baseline was performed by the Investigator at each visit using 5 level scale: significantly better, slightly better, unchanged, slightly worse, significantly worse. The number of patients for each variable at each indicated timepoint are reported.

  • Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit [ Time Frame: Baseline and Weeks 2, 6, 10, 14 and 18 ]
    A global assessment of the patient's current condition relative to baseline was performed by the patient at each visit using a 5 level scale: significantly better, slightly better, unchanged, slightly worse, significantly worse. The number of patients for each variable at each indicated timepoint are reported.


Enrollment: 40
Study Start Date: July 2005
Study Completion Date: April 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botulinum type A toxin (Dysport®) Drug: Botulinum type A toxin (Dysport®)
Botulinum type A toxin (Dysport®): 200 Units injected at the root of the plantar fascia
Other Name: AbobotulinumtoxinA (non-proprietary name)
Placebo Comparator: Placebo Other: Placebo
0.9% sodium chloride: 2 ml injected at the root of the plantar fascia

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447876

Locations
Germany
University Hospital Charite, Campus Virchow, Musculoskeletal Centre, Orthopedic Clinic
Berlin, Germany, 13353
Orthopedic Practice Biberburg
Berlin, Germany, 14089
Orthopedic Practice
Karlsruhe, Germany, 76133
Klinik für Orthopädie und Rheumatologie, Universitätsklinikum Gießen und Marburg GmbH
Marburg, Germany
Orthocentre Munich
Munich, Germany, 81547
Orthopedic Practice
Weiden, Germany, 92637
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Bert Van Eijk, MD Ipsen
  More Information

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00447876     History of Changes
Other Study ID Numbers: A-94-52120-100
Study First Received: March 13, 2007
Results First Received: April 6, 2017
Last Updated: April 6, 2017

Additional relevant MeSH terms:
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases
abobotulinumtoxinA
Botulinum Toxins, Type A
onabotulinumtoxinA
incobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 23, 2017