RELIEF Study: Lower Limb Pain Relief After Injection Cycles in Adults Suffering From Lower Limb Spasticity Following Stroke

Study Overview
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Brief Summary
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The objective of this study is to demonstrate the effect of intramuscular BoNT-A injections in relieving pain, in a broad population of patients who suffer pain as the primary problem associated with spasticity. Thus, this study will help to expand the information that is available regarding the impact of BoNT-A treatment in routine clinical practice conditions. Treatment goals can vary greatly from one patient to another and there is no unique, single outcome that reflects the treatment benefits in all the cases. Therefore, this study with special focus on the achievement of therapeutic goals, will allow the identification of each patient's specific goals regarding the improvement of the functional outcomes, the quality of life and patient well-being.

Official Title
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A Prospective, Observational Study to Assess Pain Relief After 4 Botulinum Toxin Type A (BoNT-A) Injection Cycles in Patients With Post-stroke Lower Limb Spasticity

Conditions
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Lower Limb Spasticity

Intervention / Treatment
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* Biological: Botulinum toxin type A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women age 18 years and above Post-stroke lower-limb spasticity Prior agreement with the patient to inject BoNT-A If previously treated with BoNT-A, (at least 3 months interval between last injection and inclusion). Therapeutic goals agreed jointly with the patient Functional Ambulation Classification (FAC) score 2-5 Capacity to comply with the protocol Written informed consent Exclusion Criteria: Documented positive antigenicity to botulinum toxin Neuromuscular disease Use of medications that interfere with neuromuscular transmission Severe muscle atrophy in any muscle to be injected Any other indication that might interfere with rehabilitation or the evaluation of results Any non-stroke spasticity diagnosis Pregnancy or nursing mothers Previous participation in any study using Goal Attainment Scale (GAS)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post-stroke lower limb spasticity patients<br> | Biological: Botulinum toxin type A<br>* This is an observational study designed to reflect the clinical practice in real life as closely as possible. Botulinum Toxin Type A (BoNT-A) injection administered according to the local Summary of Product Characteristics (SmPC) and the locally agreed treatment guidelines.<br>* Other names: AbobotulinumtoxinA (Dysport®);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain relief on Numeric Rating Scale | Pain relief evaluated by Numeric Rating Scale (NRS). The NRS score for patient self-reporting of pain ranging from 0 (no pain) to 10 (the most severe pain). | Baseline visit and every 4 months up to 16 months (Visit 5). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain relief on Visual Assessment Scale | Pain relief evaluated by measuring changes in Visual Assessment Scale (VAS). The VAS used a 100 mm line in which values were reported, 0 (no pain) to 10 (the most severe pain). | Baseline visit and every 4 months up to 16 months (Visit 5). | 
| Responder rate using goal Attainment Scale | Responder rate assessed on the Goal Attainment Scale (GAS). GAS is a 5-point scale, with the degree of attainment captured for each goal area. | Every 4 months up to 16 months (Visit 5). |