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

• Sponsor: Ipsen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00447876
• Collaborator: (none)
• Enrollment: 40
• Locations: 6
• Arms: 2
• Duration (Months): 45
• Patients Per Site: 6.7
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Plantar Fasciitis	Biological: Botulinum toxin type A; Drug: Placebo	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Jul 1, 2005
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Botulinum type A toxin (Dysport®)	Biological: Botulinum toxin type A; Botulinum type A toxin (Dysport®): 200 Units injected at the root of the plantar fascia; Other Names: AbobotulinumtoxinA (Dysport®)
Placebo Comparator: Placebo	Drug: Placebo; 0.9% sodium chloride: 2 ml injected at the root of the plantar fascia

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Charite, Campus Virchow, Musculoskeletal Centre, Orthopedic Clinic	Berlin		Germany	13353
2	Orthopedic Practice Biberburg	Berlin		Germany	14089
3	Orthopedic Practice	Karlsruhe		Germany	76133
4	Klinik für Orthopädie und Rheumatologie, Universitätsklinikum Gießen und Marburg GmbH	Marburg		Germany
5	Orthocentre Munich	Munich		Germany	81547
6	Orthopedic Practice	Weiden		Germany	92637

Sponsors and Collaborators

• Ipsen

Investigators

• Study Director: Ipsen Medical Director, Ipsen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ipsen
• ClinicalTrials.gov Identifier: NCT00447876
• Other Study ID Numbers: A-94-52120-100; 2004-002533-39
• First Posted: Mar 15, 2007
• Last Update Posted: Nov 22, 2019
• Last Verified: Nov 1, 2019

• Additional relevant MeSH terms: Fasciitis; Fasciitis, Plantar; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA

Study Results

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 Detail	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.

Arm/Group Title	Dysport ® 200 U	Placebo
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	20	20
COMPLETED	17	16
NOT COMPLETED	3	4

Baseline Characteristics

Arm/Group Title	Dysport ® 200 U	Placebo	Total Title
Arm/Group Description	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.	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.
Overall Participants	20	20	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.4 (10.7)	51.8 (11.3)	52.1 (10.9)
Sex: Female, Male (Count of Participants)
Female	17 85%	15 75%	32 80%
Male	3 15%	5 25%	8 20%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Dysport ® 200 U	Placebo
Arm/Group Description	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.	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.
Measure Participants	20	20
Number [Percentage of participants]	25.0 125%	5.0 25%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dysport ® 200 U, Placebo
	Comments	The responders rate at Week 6 was compared between treatment groups by a two-sided Fisher exact test.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	=0.182
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Treatment difference
	Estimated Value	0.20
	Confidence Interval	(2-Sided) 95%; -0.06 to 0.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Dysport ® 200 U	Placebo
Arm/Group Description	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.	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.
Measure Participants	15	15
Baseline score = I; Week 18 score = I	40.0 200%	60.0 300%
Baseline score = II; Week 18 score = I	26.7 133.5%	6.7 33.5%
Baseline score = II; Week 18 score = II	6.7 33.5%	20.0 100%
Baseline score = II; Week 18 score = III	6.7 33.5%	0.0 0%
Baseline score = III; Week 18 score = I	6.7 33.5%	6.7 33.5%
Baseline score = III; Week 18 score = II	6.7 33.5%	6.7 33.5%
Baseline score = III; Week 18 score = III	6.7 33.5%	0.0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dysport ® 200 U, Placebo
	Comments	Gerbershagen's Global scores were compared at Week 18 using a Cochran-Mantel-Haenszel analysis of variance statistic with adjustment to the baseline score.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	=0.222
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Dysport ® 200 U	Placebo
Arm/Group Description	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.	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.
Measure Participants	20	20
PID Week 2 (maximum pain)	-1.38 (2.66)	-1.18 (1.98)
PID Week 6 (maximum pain)	-1.55 (3.27)	-1.35 (1.85)
PID Week 10 (maximum pain)	-1.75 (3.32)	-1.25 (1.99)
PID Week 14 (maximum pain)	-2.48 (3.59)	-1.30 (2.59)
PID Week 18 (maximum pain)	-2.45 (3.52)	-1.80 (3.17)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Dysport ® 200 U	Placebo
Arm/Group Description	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.	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.
Measure Participants	20	20
Least Squares Mean (95% Confidence Interval) [cm * day]	-28.043	-19.207

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dysport ® 200 U, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	=0.423
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-8.837
	Confidence Interval	(2-Sided) 95%; -30.940 to 13.266
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Dysport ® 200 U	Placebo
Arm/Group Description	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.	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.
Measure Participants	20	20
PID Week 2 (continuous pain)	-0.78 (2.80)	-0.88 (2.19)
PID Week 6 (continuous pain)	-0.45 (2.70)	-1.05 (1.76)
PID Week 10 (continuous pain)	-0.63 (2.67)	-1.20 (2.98)
PID Week 14 (continuous pain)	-1.75 (2.99)	-0.98 (2.91)
PID Week 18 (continuous pain)	-1.55 (3.38)	-1.70 (3.75)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Dysport ® 200 U	Placebo
Arm/Group Description	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.	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.
Measure Participants	20	20
Least Squares Mean (95% Confidence Interval) [cm * day]	-17.511	-13.339

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dysport ® 200 U, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	=0.682
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-4.173
	Confidence Interval	(2-Sided) 95%; -24.640 to 16.294
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Dysport ® 200 U	Placebo
Arm/Group Description	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.	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.
Measure Participants	20	20
Pain threshold difference Week 2	0.80 (2.28)	0.76 (1.73)
Pain threshold difference Week 6	0.51 (2.90)	1.31 (3.95)
Pain threshold difference Week 10	0.69 (2.86)	1.50 (3.51)
Pain threshold difference Week 14	0.85 (3.41)	1.35 (2.97)
Pain threshold difference Week 18	0.83 (3.23)	2.16 (3.93)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Dysport ® 200 U	Placebo
Arm/Group Description	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.	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.
Measure Participants	20	20
Least Squares Mean (95% Confidence Interval) [(kg / cm^2) * day]	11.492	19.558

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dysport ® 200 U, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	=0.438
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-8.066
	Confidence Interval	(2-Sided) 95%; -28.910 to 12.779
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Dysport ® 200 U	Placebo
Arm/Group Description	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.	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.
Measure Participants	20	20
Pressure threshold difference Week 2	0.55 (2.21)	0.95 (1.76)
Pressure threshold difference Week 6	0.90 (2.62)	1.07 (2.01)
Pressure threshold difference Week 10	0.61 (1.79)	1.33 (2.29)
Pressure threshold difference Week 14	1.38 (2.77)	1.13 (2.20)
Pressure threshold difference Week 18	1.74 (2.98)	1.28 (2.47)

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Dysport ® 200 U	Placebo
Arm/Group Description	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.	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.
Measure Participants	20	20
Least Squares Mean (95% Confidence Interval) [(kg / cm^2) * day]	16.174	15.581

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dysport ® 200 U, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	=0.937
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	0.594
	Confidence Interval	(2-Sided) 95%; -14.575 to 15.762
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Dysport ® 200 U	Placebo
Arm/Group Description	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.	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.
Measure Participants	18	16
Least Squares Mean (95% Confidence Interval) [Degrees]	60.7	61.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dysport ® 200 U, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	=0.800
	Comments	The difference (most affected side - control side) in ROM for the dorsal extension was analyzed using a fixed effect ANCOVA, using Week 18 results as the dependent variable and baseline value as covariate.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.8
	Confidence Interval	(2-Sided) 95%; -6.8 to 5.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Dysport ® 200 U	Placebo
Arm/Group Description	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.	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.
Measure Participants	20	20
Week 2 significantly worse	0 0%	0 0%
Week 2 slightly worse	1 5%	0 0%
Week 2 unchanged	9 45%	9 45%
Week 2 slightly improved	7 35%	6 30%
Week 2 significantly improved	3 15%	3 15%
Week 6 significantly worse	2 10%	2 10%
Week 6 slightly worse	0 0%	0 0%
Week 6 unchanged	6 30%	9 45%
Week 6 slightly improved	7 35%	8 40%
Week 6 significantly improved	4 20%	1 5%
Week 10 significantly worse	2 10%	3 15%
Week 10 slightly worse	2 10%	2 10%
Week 10 unchanged	2 10%	3 15%
Week 10 slightly improved	7 35%	10 50%
Week 10 significantly improved	3 15%	1 5%
Week 14 significantly worse	2 10%	1 5%
Week 14 slightly worse	1 5%	1 5%
Week 14 unchanged	4 20%	5 25%
Week 14 slightly improved	7 35%	7 35%
Week 14 significantly improved	4 20%	3 15%
Week 18 significantly worse	2 10%	5 25%
Week 18 slightly worse	0 0%	0 0%
Week 18 unchanged	4 20%	3 15%
Week 18 slightly improved	6 30%	8 40%
Week 18 significantly improved	6 30%	4 20%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dysport ® 200 U, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	=0.862
	Comments
	Method	Wilcoxon rank sum test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Dysport ® 200 U, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	=0.317
	Comments
	Method	Wilcoxon rank sum test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Dysport ® 200 U, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	=0.525
	Comments
	Method	Wilcoxon rank sum test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Dysport ® 200 U, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	=0.931
	Comments
	Method	Wilcoxon rank sum test
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Dysport ® 200 U, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	=0.353
	Comments
	Method	Wilcoxon rank sum test
	Comments

13. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Dysport ® 200 U	Placebo
Arm/Group Description	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.	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.
Measure Participants	20	20
Week 2 significantly worse	0 0%	0 0%
Week 2 slightly worse	3 15%	2 10%
Week 2 unchanged	7 35%	9 45%
Week 2 slightly improved	7 35%	5 25%
Week 2 significantly improved	3 15%	3 15%
Week 6 significantly worse	3 15%	2 10%
Week 6 slightly worse	0 0%	1 5%
Week 6 unchanged	6 30%	9 45%
Week 6 slightly improved	6 30%	6 30%
Week 6 significantly improved	4 20%	2 10%
Week 10 significantly worse	4 20%	3 15%
Week 10 slightly worse	2 10%	2 10%
Week 10 unchanged	3 15%	3 15%
Week 10 slightly improved	4 20%	7 35%
Week 10 significantly improved	4 20%	4 20%
Week 14 significantly worse	2 10%	1 5%
Week 14 slightly worse	3 15%	2 10%
Week 14 unchanged	3 15%	4 20%
Week 14 slightly improved	7 35%	5 25%
Week 14 significantly improved	3 15%	5 25%
Week 18 significantly worse	3 15%	5 25%
Week 18 slightly worse	2 10%	0 0%
Week 18 unchanged	2 10%	4 20%
Week 18 slightly improved	5 25%	7 35%
Week 18 significantly improved	7 35%	4 20%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dysport ® 200 U, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	=0.882
	Comments
	Method	Wilcoxon rank sum test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Dysport ® 200 U, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	=0.489
	Comments
	Method	Wilcoxon rank sum test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Dysport ® 200 U, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	=0.660
	Comments
	Method	Wilcoxon rank sum test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Dysport ® 200 U, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	=0.485
	Comments
	Method	Wilcoxon rank sum test
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Dysport ® 200 U, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	=0.392
	Comments
	Method	Wilcoxon rank sum test
	Comments

Adverse Events

Time Frame	Up to Week 18
Adverse Event Reporting Description	Adverse events are described in terms of incidence of Treatment Emergent Adverse Events. Safety was assessed on all randomized patients who received study treatment and were assessed for safety at least once after baseline.
Arm/Group Title	Dysport ® 200 U		Placebo
Arm/Group Description	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.		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.
All Cause Mortality
	Dysport ® 200 U		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Dysport ® 200 U		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/20 (10%)		0/20 (0%)
Gastrointestinal disorders
Gastrointestinal inflammation	1/20 (5%)	1	0/20 (0%)	0
Infections and infestations
Diverticulitis	1/20 (5%)	1	0/20 (0%)	0
Other (Not Including Serious) Adverse Events
	Dysport ® 200 U		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/20 (35%)		8/20 (40%)
Gastrointestinal disorders
Haemorrhoids	1/20 (5%)	1	0/20 (0%)	0
General disorders
Injection site pain	1/20 (5%)	1	0/20 (0%)	0
Infections and infestations
Tinea pedis	1/20 (5%)	1	0/20 (0%)	0
Nasopharyngitis	0/20 (0%)	0	1/20 (5%)	1
Injury, poisoning and procedural complications
Fall	1/20 (5%)	1	0/20 (0%)	0
Contusion	0/20 (0%)	0	1/20 (5%)	2
Musculoskeletal and connective tissue disorders
Pain in extremity	2/20 (10%)	2	0/20 (0%)	0
Arthropathy	1/20 (5%)	1	0/20 (0%)	0
Plantar fasciitis	1/20 (5%)	1	2/20 (10%)	2
Synovial cyst	1/20 (5%)	1	0/20 (0%)	0
Trigger finger	1/20 (5%)	1	0/20 (0%)	0
Arthralgia	0/20 (0%)	0	1/20 (5%)	1
Back pain	0/20 (0%)	0	1/20 (5%)	1
Myalgia	0/20 (0%)	0	1/20 (5%)	1
Osteoarthritis	0/20 (0%)	0	2/20 (10%)	2
Respiratory, thoracic and mediastinal disorders
Asthma	1/20 (5%)	1	0/20 (0%)	0
Skin and subcutaneous tissue disorders
Rash	1/20 (5%)	1	0/20 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.