RELIEF Study: Lower Limb Pain Relief After Injection Cycles in Adults Suffering From Lower Limb Spasticity Following Stroke (RELIEF)
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|ClinicalTrials.gov Identifier: NCT02020980|
Recruitment Status : Completed
First Posted : December 25, 2013
Last Update Posted : July 29, 2019
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.
|Condition or disease||Intervention/treatment|
|Lower Limb Spasticity||Biological: Botulinum toxin type A|
|Study Type :||Observational|
|Actual Enrollment :||186 participants|
|Official Title:||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|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||March 5, 2018|
|Actual Study Completion Date :||March 5, 2018|
|Post-stroke lower limb spasticity patients||
Biological: Botulinum toxin type A
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.
Other Name: AbobotulinumtoxinA (Dysport®)
- Change in Pain relief on Numeric Rating Scale [ Time Frame: Baseline visit and every 4 months up to 16 months (Visit 5). ]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).
- Change in Pain relief on Visual Assessment Scale [ Time Frame: Baseline visit and every 4 months up to 16 months (Visit 5). ]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).
- Responder rate using goal Attainment Scale [ Time Frame: Every 4 months up to 16 months (Visit 5). ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020980
|Study Director:||Ipsen Medical Director||Ipsen|