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

Ipsen40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Plantar Fasciitis

Interventions

Botulinum toxin type ABIOLOGICAL

Botulinum type A toxin (Dysport®): 200 Units injected at the root of the plantar fascia

PlaceboDRUG

0.9% sodium chloride: 2 ml injected at the root of the plantar fascia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

University Hospital Charite, Campus Virchow, Musculoskeletal Centre, Orthopedic Clinic

Berlin, Germany

Orthopedic Practice Biberburg

Berlin, Germany

Orthopedic Practice

Karlsruhe, Germany

Klinik für Orthopädie und Rheumatologie, Universitätsklinikum Gießen und Marburg GmbH

Marburg, Germany

Outcomes

Primary Outcomes

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.

Time frame: Baseline and Week 6

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline and Weeks 2, 6, 10, 14 and 18

Data from ClinicalTrials.gov

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Orthocentre Munich

Munich, Germany

Orthopedic Practice

Weiden, Germany

Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline and Weeks 2, 6, 10, 14 and 18