Back to resultsStudy to Assess the Efficacy and Safety of Dysport® in the Treatment of Chronic Plantar Fasciitis
Primary Purpose
Chronic Plantar Fasciitis
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Botulinum toxin type A
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic 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
Sites / Locations
- University Hospital Charite, Campus Virchow, Musculoskeletal Centre, Orthopedic Clinic
- Orthopedic Practice Biberburg
- Orthopedic Practice
- Klinik für Orthopädie und Rheumatologie, Universitätsklinikum Gießen und Marburg GmbH
- Orthocentre Munich
- Orthopedic Practice
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Botulinum type A toxin (Dysport®)
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Responders Rate at Week 6 (Pain While Moving)
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
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
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
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
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
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
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
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
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
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00447876
Brief Title
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
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plantar Fasciitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Botulinum type A toxin (Dysport®)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
AbobotulinumtoxinA (Dysport®)
Intervention Description
Botulinum type A toxin (Dysport®): 200 Units injected at the root of the plantar fascia
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0.9% sodium chloride: 2 ml injected at the root of the plantar fascia
Primary Outcome Measure Information:
Title
Responders Rate at Week 6 (Pain While Moving)
Description
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.
Time Frame
Baseline and Week 6
Secondary Outcome Measure Information:
Title
Changes From Baseline in Gerbershagen's Score at Week 18
Description
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.
Time Frame
Baseline and Week 18
Title
Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit
Description
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.
Time Frame
Baseline and Weeks 2, 6, 10, 14 and 18
Title
Assessment of Sum of Pain Intensity Difference (SPID) for Maximum Pain for Overall Study
Description
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.
Time Frame
Baseline and Weeks 2, 6, 10, 14 and 18
Title
Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit
Description
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.
Time Frame
Baseline and Weeks 2, 6, 10, 14 and 18
Title
Assessment of SPID for Continuous Pain for Overall Study
Description
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.
Time Frame
Baseline and Weeks 2, 6, 10, 14 and 18
Title
Changes From Baseline in Pain Threshold at Each Visit
Description
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.
Time Frame
Baseline and Weeks 2, 6, 10, 14 and 18
Title
Assessment of Sum of Pain Threshold Differences (by Measurement of AUC) for Overall Study
Description
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.
Time Frame
Baseline and Weeks 2, 6, 10, 14 and 18
Title
Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit
Description
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.
Time Frame
Baseline and Weeks 2, 6, 10, 14 and 18
Title
Assessment of Sum of Pressure Threshold Differences (by Measurement of AUC) for Overall Study
Description
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.
Time Frame
Baseline and Weeks 2, 6, 10, 14 and 18
Title
Assessment of Dorsal Extension / Plantar Flexion Range of Motion (ROM) of the Affected Foot At Week 18
Description
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.
Time Frame
Baseline and Week 18
Title
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit
Description
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.
Time Frame
Baseline and Weeks 2, 6, 10, 14 and 18
Title
Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit
Description
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.
Time Frame
Baseline and Weeks 2, 6, 10, 14 and 18
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Charite, Campus Virchow, Musculoskeletal Centre, Orthopedic Clinic
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Orthopedic Practice Biberburg
City
Berlin
ZIP/Postal Code
14089
Country
Germany
Facility Name
Orthopedic Practice
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
Klinik für Orthopädie und Rheumatologie, Universitätsklinikum Gießen und Marburg GmbH
City
Marburg
Country
Germany
Facility Name
Orthocentre Munich
City
Munich
ZIP/Postal Code
81547
Country
Germany
Facility Name
Orthopedic Practice
City
Weiden
ZIP/Postal Code
92637
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
22673486
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.
Results Reference
result
Learn more about this trial
Study to Assess the Efficacy and Safety of Dysport® in the Treatment of Chronic Plantar Fasciitis
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