Post-stroke Spasticity of the Upper Limb. Clinical Trial
— PUREOfficial title:
Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Post-stroke Spasticity of the Upper Limb
| Verified date | January 2016 |
| Source | Merz Pharmaceuticals GmbH |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the upper limb are effective in treating spasticity in patients after stroke.
| Status | Completed |
| Enrollment | 317 |
| Est. completion date | February 2014 |
| Est. primary completion date | March 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Upper limb spasticity - Time since stroke greater than 3 months - Need for 400 U Botulinum toxin type A Exclusion Criteria: - Body weight below 50kg - Fixed contractures of the upper limb - Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin Type A - Infection at the injection site |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Czech Republic | Merz Investigational Site #420029 | Brno | |
| Czech Republic | Merz Investigational Site #420046 | Brno | |
| Czech Republic | Merz Investigational Site #420028 | Olomouc | |
| Czech Republic | Merz Investigational Site #420024 | Ostrava-Poruba | |
| Czech Republic | Merz Investigational Site #420025 | Pardubice | |
| Czech Republic | Merz Investigational Site #420030 | Praha | |
| Czech Republic | Merz Investigational Site #420045 | Praha | |
| Czech Republic | Merz Investigational Site #420047 | Rychnov nad Kneznou | |
| Germany | Merz Investigational Site #049134 | Rostock | |
| Hungary | Merz Investigational Site # 036009 | Budapest | |
| Hungary | Merz Investigational Site #036004 | Budapest | |
| Hungary | Merz Investigational Site #036005 | Nyiregyhaza | |
| Hungary | Merz Investigational Site #036008 | Szeged | |
| India | Merz Investigational Site #091006 | Bangalore | Karnataka |
| India | Merz Investigational Site #091007 | Chennai | Tamil Nadu |
| India | Merz Investigational Site #091008 | Coimbatore | Tamil Nadu |
| India | Merz Investigational Site #091001 | Lucknow | Uttar Pradesh |
| India | Merz Investigational Site #091004 | New Delhi | |
| India | Merz Investigational Site #091003 | Porur | Chennai |
| India | Merz Investigational Site #091002 | Trivandrum | Kerala |
| Poland | Merz Investigational Site # 048029 | Gdansk | |
| Poland | Merz Investigational Site #048044 | Kielce | |
| Poland | Merz Investigational Site #048031 | Krakow | |
| Poland | Merz Investigational Site #048050 | Lodz | |
| Poland | Merz Investigational Site #048051 | Lublin | |
| Poland | Merz Investigational Site #048032 | Olsztyn | |
| Poland | Merz Investigational Site #048053 | Poznan | |
| Poland | Merz Investigational Site #048023 | Warszawa | |
| Poland | Merz Investigational Site #048033 | Warszawa | |
| Poland | Merz Investigational Site #048052 | Warszawa | |
| Russian Federation | Merz Investigational Site #007010 | Krasnoyarsk | |
| Russian Federation | Merz Investigational Site #007011 | Moscow | |
| Russian Federation | Merz Investigational Site #007009 | St. Petersburg | |
| Russian Federation | Merz Investigational Site #007005 | Stavropol | |
| United States | Merz Investigational Site #001037 | Augusta | Georgia |
| United States | Merz Investigational Site #001240 | Chapel Hill | North Carolina |
| United States | Merz Investigational Site #001245 | Chattanooga | Tennessee |
| United States | Merz Investigational Site #001186 | Chicago | Illinois |
| United States | Merz Investigational Site #001184 | Downey | California |
| United States | Merz Investigational Site #001017 | Fountain Valley | California |
| United States | Merz Investigational Site #001226 | Houston | Texas |
| United States | Merz Investigational Site #001188 | Miami | Florida |
| United States | Merz Investigational Site # 001110 | Overland Park | Kansas |
| United States | Merz Investigational Site #001241 | Philadelphia | Pennsylvania |
| United States | Merz Investigational Site #001211 | Pittsburgh | Pennsylvania |
| United States | Merz Investigational Site #001198 | Stratford | New Jersey |
| United States | Merz Investigational Site #001009 | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Merz Pharmaceuticals GmbH |
United States, Czech Republic, Germany, Hungary, India, Poland, Russian Federation,
Elovic EP, Munin MC, Kanovský P, Hanschmann A, Hiersemenzel R, Marciniak C. Randomized, placebo-controlled trial of incobotulinumtoxina for upper-limb post-stroke spasticity. Muscle Nerve. 2016 Mar;53(3):415-21. doi: 10.1002/mus.24776. Epub 2015 Dec 15. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern | Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
Week 4 | No |
| Primary | Investigator's Global Impression of Change | This is the co-primary outcome measure. The Global Impression of Change Scale [GICS] is used to measure the investigator's impression of change due to treatment. The response option is a common 7-point Likert scale that ranges from -3 = very much worse to +3 = very much improved. | Week 4 | No |
| Secondary | Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern | Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. | Week 4 | No |
| Secondary | Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern | Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. | Week 8 | No |
| Secondary | Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern | Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. | Week 12 | No |
| Secondary | Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Wrist | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. | Week 4 | No |
| Secondary | Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Wrist | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. | Week 8 | No |
| Secondary | Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Wrist | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. | Week 12 | No |
| Secondary | Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Elbow | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. | Week 4 | No |
| Secondary | Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Elbow | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. | Week 8 | No |
| Secondary | Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Elbow | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. | Week 12 | No |
| Secondary | Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Clenched Fist | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. | Week 4 | No |
| Secondary | Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Clenched Fist | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. | Week 8 | No |
| Secondary | Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Clenched Fist | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. | Week 12 | No |
| Secondary | Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Thumb-in-palm | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. | Week 4 | No |
| Secondary | Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Thumb-in-palm | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. | Week 8 | No |
| Secondary | Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Thumb-in-palm | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. | Week 12 | No |
| Secondary | Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Pronated Forearm | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. | Week 4 | No |
| Secondary | Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Pronated Forearm | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. | Week 8 | No |
| Secondary | Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Pronated Forearm | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis. | Week 12 | No |
| Secondary | Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist. | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). | Week 4 | No |
| Secondary | Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist. | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). | Week 8 | No |
| Secondary | Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist. | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). | Week 12 | No |
| Secondary | Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow. | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). | Week 4 | No |
| Secondary | Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow. | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). | Week 8 | No |
| Secondary | Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow. | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). | Week 12 | No |
| Secondary | Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Clenched Fist. | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). | Week 4 | No |
| Secondary | Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Clenched Fist. | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). | Week 8 | No |
| Secondary | Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Clenched Fist. | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). | Week 12 | No |
| Secondary | Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm. | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). | Week 4 | No |
| Secondary | Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm. | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). | Week 8 | No |
| Secondary | Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm. | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). | Week 12 | No |
| Secondary | Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm. | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). | Week 4 | No |
| Secondary | Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm. | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). | Week 8 | No |
| Secondary | Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm. | The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). | Week 12 | No |
| Secondary | Changes From Baseline to Week 4 in Disability Assessment Scale - Principal Therapeutic Target Domain | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). | Week 4 | No |
| Secondary | Changes From Baseline to Week 8 in Disability Assessment Scale - Principal Therapeutic Target Domain | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). | Week 8 | No |
| Secondary | Changes From Baseline to Week 12 in Disability Assessment Scale - Principal Therapeutic Target Domain | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). | Week 12 | No |
| Secondary | Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Hygiene | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). | Week 4 | No |
| Secondary | Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Hygiene | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). | Week 8 | No |
| Secondary | Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Hygiene | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). | Week 12 | No |
| Secondary | Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Dressing | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). | Week 4 | No |
| Secondary | Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Dressing | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). | Week 8 | No |
| Secondary | Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Dressing | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). | Week 12 | No |
| Secondary | Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Limb Position | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). | Week 4 | No |
| Secondary | Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Limb Position | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). | Week 8 | No |
| Secondary | Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Limb Position | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). | Week 12 | No |
| Secondary | Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Pain | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). | Week 4 | No |
| Secondary | Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Pain | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). | Week 8 | No |
| Secondary | Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Pain | The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). | Week 12 | No |