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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.

Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 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.

The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. This variable could only be analyzed for 30 patients (15 from each group) for whom the score could be determined both at baseline and at Week 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.

The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.

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.

The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.

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.

The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.

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.

The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.

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.

The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.

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.

The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.

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.

The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.

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.

The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. Missing values were replaced using the LOCF method.

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.

The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint. This variable was only analyzed for 34 patients (18 for Dysport® and 16 for Placebo) for whom ROM was determined at both baseline and Week 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.

The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint.

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.

The ITT analysis set was defined as the set of randomized patients who received study treatment and for whom values of the efficacy parameters were available at baseline and at least one later timepoint.

Patients received one injection of placebo (physiological sodium chloride solution, 2ml) at Week 0 (Day 0). The study treatment was injected into the origin of the plantar fascia in accordance with the clinical findings on palpation, the injection being distributed in four portions in a fan-shaped manner using a single 0.50 x 40mm needle. Follow-up examinations to assess the efficacy and safety of the treatment were performed at Weeks 2, 6, 10, 14 and 18.

Dysport® vs placebo at Week 10. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.

Dysport® vs placebo at Week 14. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.

Dysport® vs placebo at Week 18. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.

Dysport® vs placebo at Week 10. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.

Dysport® vs placebo at Week 14. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.

Dysport® vs placebo at Week 18. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.