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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Plantar Fasciitis

Intervention / Treatment
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* Biological: Botulinum toxin type A
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum type A toxin (Dysport®)<br> | Biological: Botulinum toxin type A<br>* Botulinum type A toxin (Dysport®): 200 Units injected at the root of the plantar fascia<br>* Other names: AbobotulinumtoxinA (Dysport®);|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 0.9% sodium chloride: 2 ml injected at the root of the plantar fascia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and Week 18 | 
| 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. | Baseline and Weeks 2, 6, 10, 14 and 18 | 
| 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. | Baseline and Weeks 2, 6, 10, 14 and 18 | 
| 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. | Baseline and Weeks 2, 6, 10, 14 and 18 | 
| 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. | Baseline and Weeks 2, 6, 10, 14 and 18 | 
| 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. | Baseline and Weeks 2, 6, 10, 14 and 18 | 
| 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. | Baseline and Weeks 2, 6, 10, 14 and 18 | 
| 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. | Baseline and Weeks 2, 6, 10, 14 and 18 | 
| 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. | Baseline and Weeks 2, 6, 10, 14 and 18 | 
| 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. | Baseline and Week 18 | 
| 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. | Baseline and Weeks 2, 6, 10, 14 and 18 | 
| 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. | Baseline and Weeks 2, 6, 10, 14 and 18 |