Chronic Plantar Fasciitis
Conditions
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.
Interventions
BIOLOGICALBotulinum toxin type A
Botulinum type A toxin (Dysport®): 200 Units injected at the root of the plantar fascia
DRUGPlacebo
0.9% sodium chloride: 2 ml injected at the root of the plantar fascia
Sponsors
Ipsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responders Rate at Week 6 (Pain While Moving) | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit | 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 | 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 | 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 | 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 | 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. |
| Changes From Baseline in Gerbershagen's Score at Week 18 | 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 Pressure Threshold (With Algometer) at Each Visit | 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 | 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 | 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 | 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 | 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. |
| Assessment of Sum of Pain Threshold Differences (by Measurement of AUC) for Overall Study | 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. |
Countries
Germany
Participant flow
Recruitment details
The study was a double-blind, placebo-controlled, randomized, prospective study where patients were recruited to 5 study centres in Germany. Patients were enrolled to the study from 08 July 2005 (first patent enrolled) until 23 April 2009 (last patient completed).
Pre-assignment details
40 patients were enrolled. Patients were assigned to treatment if they met all inclusion and none of the exclusion criteria. All patients enrolled were randomized and received study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Dysport ® 200 U Patients received one injection of 200 units (U) Dysport® 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. | 20 |
| Placebo 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. | 20 |
| Total Title | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Deterioration of symptomology | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | Dysport ® 200 U | Placebo | Total Title |
|---|---|---|---|
| Age, Continuous | 52.4 years STANDARD_DEVIATION 10.7 | 51.8 years STANDARD_DEVIATION 11.3 | 52.1 years STANDARD_DEVIATION 10.9 |
| Sex: Female, Male Female | 17 Participants | 15 Participants | 32 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 7 / 20 | 8 / 20 |
| serious Total, serious adverse events | 2 / 20 | 0 / 20 |
Outcome results
Primary
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
Population: The Intention-To-Treat (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 once at a later timepoint. Missing values were replaced using the last observation carried forward (LOCF) method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dysport ® 200 U | Responders Rate at Week 6 (Pain While Moving) | 25.0 Percentage of participants |
| Placebo | Responders Rate at Week 6 (Pain While Moving) | 5.0 Percentage of participants |
Comparison: The responders rate at Week 6 was compared between treatment groups by a two-sided Fisher exact test.p-value: =0.18295% CI: [-0.06, 0.46]Fisher Exact
Secondary
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
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Dysport ® 200 U | Assessment of Dorsal Extension / Plantar Flexion Range of Motion (ROM) of the Affected Foot At Week 18 | 60.7 Degrees |
| Placebo | Assessment of Dorsal Extension / Plantar Flexion Range of Motion (ROM) of the Affected Foot At Week 18 | 61.4 Degrees |
p-value: =0.895% CI: [-6.8, 5.3]ANCOVA
Secondary
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
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Dysport ® 200 U | Assessment of SPID for Continuous Pain for Overall Study | -17.511 cm * day |
| Placebo | Assessment of SPID for Continuous Pain for Overall Study | -13.339 cm * day |
Comparison: SPID was compared between the two treatment groups using a fixed effect ANCOVA taking into account the SPID value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.p-value: =0.68295% CI: [-24.64, 16.294]ANCOVA
Secondary
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
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Dysport ® 200 U | Assessment of Sum of Pain Intensity Difference (SPID) for Maximum Pain for Overall Study | -28.043 cm * day |
| Placebo | Assessment of Sum of Pain Intensity Difference (SPID) for Maximum Pain for Overall Study | -19.207 cm * day |
Comparison: SPID was compared between the two treatment groups using a fixed effect analysis of covariance (ANCOVA) taking into account the SPID value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.p-value: =0.42395% CI: [-30.94, 13.266]ANCOVA
Secondary
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
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Dysport ® 200 U | Assessment of Sum of Pain Threshold Differences (by Measurement of AUC) for Overall Study | 11.492 (kg / cm^2) * day |
| Placebo | Assessment of Sum of Pain Threshold Differences (by Measurement of AUC) for Overall Study | 19.558 (kg / cm^2) * day |
Comparison: The sum of pain threshold difference (i.e. SPID expressed as AUC) was compared between the two treatment groups using a fixed effect ANCOVA taking into account the SPID AUC value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.p-value: =0.43895% CI: [-28.91, 12.779]ANCOVA
Secondary
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
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Dysport ® 200 U | Assessment of Sum of Pressure Threshold Differences (by Measurement of AUC) for Overall Study | 16.174 (kg / cm^2) * day |
| Placebo | Assessment of Sum of Pressure Threshold Differences (by Measurement of AUC) for Overall Study | 15.581 (kg / cm^2) * day |
Comparison: The sum of pressure threshold difference (i.e. SPID expressed as AUC) was compared between the two treatment groups using a fixed effect ANCOVA taking into account the SPID AUC value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.p-value: =0.93795% CI: [-14.575, 15.762]ANCOVA
Secondary
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.
Time frame: Baseline and Weeks 2, 6, 10, 14 and 18
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dysport ® 200 U | Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit | PID Week 6 (continuous pain) | -0.45 cm | Standard Deviation 2.7 |
| Dysport ® 200 U | Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit | PID Week 14 (continuous pain) | -1.75 cm | Standard Deviation 2.99 |
| Dysport ® 200 U | Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit | PID Week 10 (continuous pain) | -0.63 cm | Standard Deviation 2.67 |
| Dysport ® 200 U | Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit | PID Week 18 (continuous pain) | -1.55 cm | Standard Deviation 3.38 |
| Dysport ® 200 U | Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit | PID Week 2 (continuous pain) | -0.78 cm | Standard Deviation 2.8 |
| Placebo | Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit | PID Week 18 (continuous pain) | -1.70 cm | Standard Deviation 3.75 |
| Placebo | Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit | PID Week 2 (continuous pain) | -0.88 cm | Standard Deviation 2.19 |
| Placebo | Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit | PID Week 6 (continuous pain) | -1.05 cm | Standard Deviation 1.76 |
| Placebo | Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit | PID Week 10 (continuous pain) | -1.20 cm | Standard Deviation 2.98 |
| Placebo | Changes From Baseline in Continuous Pain (Pain At Rest) at Each Visit | PID Week 14 (continuous pain) | -0.98 cm | Standard Deviation 2.91 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dysport ® 200 U | Changes From Baseline in Gerbershagen's Score at Week 18 | Baseline score = III; Week 18 score = II | 6.7 Percentage of participants |
| Dysport ® 200 U | Changes From Baseline in Gerbershagen's Score at Week 18 | Baseline score = II; Week 18 score = II | 6.7 Percentage of participants |
| Dysport ® 200 U | Changes From Baseline in Gerbershagen's Score at Week 18 | Baseline score = I; Week 18 score = I | 40.0 Percentage of participants |
| Dysport ® 200 U | Changes From Baseline in Gerbershagen's Score at Week 18 | Baseline score = III; Week 18 score = I | 6.7 Percentage of participants |
| Dysport ® 200 U | Changes From Baseline in Gerbershagen's Score at Week 18 | Baseline score = II; Week 18 score = III | 6.7 Percentage of participants |
| Dysport ® 200 U | Changes From Baseline in Gerbershagen's Score at Week 18 | Baseline score = III; Week 18 score = III | 6.7 Percentage of participants |
| Dysport ® 200 U | Changes From Baseline in Gerbershagen's Score at Week 18 | Baseline score = II; Week 18 score = I | 26.7 Percentage of participants |
| Placebo | Changes From Baseline in Gerbershagen's Score at Week 18 | Baseline score = III; Week 18 score = III | 0.0 Percentage of participants |
| Placebo | Changes From Baseline in Gerbershagen's Score at Week 18 | Baseline score = III; Week 18 score = I | 6.7 Percentage of participants |
| Placebo | Changes From Baseline in Gerbershagen's Score at Week 18 | Baseline score = I; Week 18 score = I | 60.0 Percentage of participants |
| Placebo | Changes From Baseline in Gerbershagen's Score at Week 18 | Baseline score = II; Week 18 score = I | 6.7 Percentage of participants |
| Placebo | Changes From Baseline in Gerbershagen's Score at Week 18 | Baseline score = II; Week 18 score = III | 0.0 Percentage of participants |
| Placebo | Changes From Baseline in Gerbershagen's Score at Week 18 | Baseline score = III; Week 18 score = II | 6.7 Percentage of participants |
| Placebo | Changes From Baseline in Gerbershagen's Score at Week 18 | Baseline score = II; Week 18 score = II | 20.0 Percentage of participants |
Comparison: Gerbershagen's Global scores were compared at Week 18 using a Cochran-Mantel-Haenszel analysis of variance statistic with adjustment to the baseline score.p-value: =0.222Cochran-Mantel-Haenszel
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dysport ® 200 U | Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit | PID Week 10 (maximum pain) | -1.75 Centimeter (cm) | Standard Deviation 3.32 |
| Dysport ® 200 U | Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit | PID Week 6 (maximum pain) | -1.55 Centimeter (cm) | Standard Deviation 3.27 |
| Dysport ® 200 U | Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit | PID Week 2 (maximum pain) | -1.38 Centimeter (cm) | Standard Deviation 2.66 |
| Dysport ® 200 U | Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit | PID Week 18 (maximum pain) | -2.45 Centimeter (cm) | Standard Deviation 3.52 |
| Dysport ® 200 U | Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit | PID Week 14 (maximum pain) | -2.48 Centimeter (cm) | Standard Deviation 3.59 |
| Placebo | Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit | PID Week 18 (maximum pain) | -1.80 Centimeter (cm) | Standard Deviation 3.17 |
| Placebo | Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit | PID Week 6 (maximum pain) | -1.35 Centimeter (cm) | Standard Deviation 1.85 |
| Placebo | Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit | PID Week 10 (maximum pain) | -1.25 Centimeter (cm) | Standard Deviation 1.99 |
| Placebo | Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit | PID Week 2 (maximum pain) | -1.18 Centimeter (cm) | Standard Deviation 1.98 |
| Placebo | Changes From Baseline in Maximum Pain (Pain While Moving) at Each Visit | PID Week 14 (maximum pain) | -1.30 Centimeter (cm) | Standard Deviation 2.59 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dysport ® 200 U | Changes From Baseline in Pain Threshold at Each Visit | Pain threshold difference Week 6 | 0.51 Kilogram (kg) / cm^2 | Standard Deviation 2.9 |
| Dysport ® 200 U | Changes From Baseline in Pain Threshold at Each Visit | Pain threshold difference Week 14 | 0.85 Kilogram (kg) / cm^2 | Standard Deviation 3.41 |
| Dysport ® 200 U | Changes From Baseline in Pain Threshold at Each Visit | Pain threshold difference Week 10 | 0.69 Kilogram (kg) / cm^2 | Standard Deviation 2.86 |
| Dysport ® 200 U | Changes From Baseline in Pain Threshold at Each Visit | Pain threshold difference Week 18 | 0.83 Kilogram (kg) / cm^2 | Standard Deviation 3.23 |
| Dysport ® 200 U | Changes From Baseline in Pain Threshold at Each Visit | Pain threshold difference Week 2 | 0.80 Kilogram (kg) / cm^2 | Standard Deviation 2.28 |
| Placebo | Changes From Baseline in Pain Threshold at Each Visit | Pain threshold difference Week 18 | 2.16 Kilogram (kg) / cm^2 | Standard Deviation 3.93 |
| Placebo | Changes From Baseline in Pain Threshold at Each Visit | Pain threshold difference Week 2 | 0.76 Kilogram (kg) / cm^2 | Standard Deviation 1.73 |
| Placebo | Changes From Baseline in Pain Threshold at Each Visit | Pain threshold difference Week 6 | 1.31 Kilogram (kg) / cm^2 | Standard Deviation 3.95 |
| Placebo | Changes From Baseline in Pain Threshold at Each Visit | Pain threshold difference Week 10 | 1.50 Kilogram (kg) / cm^2 | Standard Deviation 3.51 |
| Placebo | Changes From Baseline in Pain Threshold at Each Visit | Pain threshold difference Week 14 | 1.35 Kilogram (kg) / cm^2 | Standard Deviation 2.97 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dysport ® 200 U | Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit | Pressure threshold difference Week 18 | 1.74 kg / cm^2 | Standard Deviation 2.98 |
| Dysport ® 200 U | Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit | Pressure threshold difference Week 6 | 0.90 kg / cm^2 | Standard Deviation 2.62 |
| Dysport ® 200 U | Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit | Pressure threshold difference Week 2 | 0.55 kg / cm^2 | Standard Deviation 2.21 |
| Dysport ® 200 U | Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit | Pressure threshold difference Week 10 | 0.61 kg / cm^2 | Standard Deviation 1.79 |
| Dysport ® 200 U | Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit | Pressure threshold difference Week 14 | 1.38 kg / cm^2 | Standard Deviation 2.77 |
| Placebo | Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit | Pressure threshold difference Week 14 | 1.13 kg / cm^2 | Standard Deviation 2.2 |
| Placebo | Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit | Pressure threshold difference Week 10 | 1.33 kg / cm^2 | Standard Deviation 2.29 |
| Placebo | Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit | Pressure threshold difference Week 18 | 1.28 kg / cm^2 | Standard Deviation 2.47 |
| Placebo | Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit | Pressure threshold difference Week 2 | 0.95 kg / cm^2 | Standard Deviation 1.76 |
| Placebo | Changes From Baseline in Pressure Threshold (With Algometer) at Each Visit | Pressure threshold difference Week 6 | 1.07 kg / cm^2 | Standard Deviation 2.01 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 6 slightly worse | 0 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 2 slightly worse | 1 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 2 unchanged | 9 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 2 slightly improved | 7 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 2 significantly improved | 3 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 6 significantly worse | 2 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 2 significantly worse | 0 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 6 unchanged | 6 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 6 slightly improved | 7 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 6 significantly improved | 4 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 10 significantly worse | 2 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 10 slightly worse | 2 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 10 slightly improved | 7 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 10 significantly improved | 3 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 14 significantly worse | 2 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 14 slightly worse | 1 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 14 unchanged | 4 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 14 slightly improved | 7 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 18 significantly worse | 2 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 18 slightly worse | 0 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 18 unchanged | 4 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 18 slightly improved | 6 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 18 significantly improved | 6 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 10 unchanged | 2 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 14 significantly improved | 4 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 14 significantly improved | 3 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 2 significantly worse | 0 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 10 slightly improved | 10 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 2 slightly worse | 0 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 18 unchanged | 3 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 2 unchanged | 9 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 10 significantly improved | 1 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 2 slightly improved | 6 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 18 significantly worse | 5 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 2 significantly improved | 3 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 14 significantly worse | 1 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 6 significantly worse | 2 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 18 significantly improved | 4 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 6 slightly worse | 0 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 14 slightly worse | 1 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 6 unchanged | 9 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 18 slightly worse | 0 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 6 slightly improved | 8 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 14 unchanged | 5 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 6 significantly improved | 1 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 18 slightly improved | 8 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 10 significantly worse | 3 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 14 slightly improved | 7 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 10 slightly worse | 2 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Investigator at Each Visit | Week 10 unchanged | 3 Number of participants |
Comparison: Dysport® vs placebo at Week 2. 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.p-value: =0.862Wilcoxon rank sum test
Comparison: Dysport® vs placebo at Week 6. 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.p-value: =0.317Wilcoxon rank sum test
Comparison: 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.p-value: =0.525Wilcoxon rank sum test
Comparison: 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.p-value: =0.931Wilcoxon rank sum test
Comparison: 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.p-value: =0.353Wilcoxon rank sum test
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 18 significantly improved | 7 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 6 significantly worse | 3 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 6 slightly worse | 0 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 18 significantly worse | 3 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 18 slightly worse | 2 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 18 slightly improved | 5 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 2 significantly worse | 0 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 2 slightly worse | 3 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 2 unchanged | 7 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 2 slightly improved | 7 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 6 unchanged | 6 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 6 slightly improved | 6 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 6 significantly improved | 4 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 10 significantly worse | 4 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 10 slightly worse | 2 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 10 unchanged | 3 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 10 slightly improved | 4 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 10 significantly improved | 4 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 14 significantly worse | 2 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 14 slightly worse | 3 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 14 unchanged | 3 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 14 slightly improved | 7 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 14 significantly improved | 3 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 18 unchanged | 2 Number of participants |
| Dysport ® 200 U | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 2 significantly improved | 3 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 18 slightly worse | 0 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 2 significantly improved | 3 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 6 significantly improved | 2 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 6 significantly worse | 2 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 14 significantly worse | 1 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 14 significantly improved | 5 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 10 significantly worse | 3 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 18 significantly worse | 5 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 14 slightly improved | 5 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 18 unchanged | 4 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 10 slightly worse | 2 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 18 significantly improved | 4 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 14 slightly worse | 2 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 2 significantly worse | 0 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 10 unchanged | 3 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 2 slightly worse | 2 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 18 slightly improved | 7 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 2 unchanged | 9 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 10 slightly improved | 7 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 2 slightly improved | 5 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 6 slightly worse | 1 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 14 unchanged | 4 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 6 unchanged | 9 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 10 significantly improved | 4 Number of participants |
| Placebo | Number of Patients Without Pain and/or With a Pain Reduction Based on Global Assessment of Pain by Patient at Each Visit | Week 6 slightly improved | 6 Number of participants |
Comparison: Dysport® vs placebo at Week 2. 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.p-value: =0.882Wilcoxon rank sum test
Comparison: Dysport® vs placebo at Week 6. 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.p-value: =0.489Wilcoxon rank sum test
Comparison: 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.p-value: =0.66Wilcoxon rank sum test
Comparison: 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.p-value: =0.485Wilcoxon rank sum test
Comparison: 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.p-value: =0.392Wilcoxon rank sum test