RELIEF Study: Lower Limb Pain Relief After Injection Cycles in Adults Suffering From Lower Limb Spasticity Following Stroke (RELIEF)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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|
- Change in Pain relief on Numeric Rating Scale [ Time Frame: Baseline visit and every 4 months up to 16 months (Visit 5). ] [ Designated as safety issue: No ]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). ] [ Designated as safety issue: No ]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). ] [ Designated as safety issue: No ]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.
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||April 2018|
|Estimated Primary Completion Date:||April 2018 (Final data collection date for primary outcome measure)|
|Post-stroke lower limb spasticity patients||
Drug: Botulinum Toxin Type A (BoNT-A) Injection
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02020980
|Hospital Marítimo Oza|
|A Coruña, Spain|
|Hospital General de Albacete|
|Hospital de Cruces|
|Hospital de Galdácano|
|Hospital Dr Negrín|
|Las Palmas, Spain|
|Las Palmas, Spain|
|Hospital San Pedro|
|Fundación Jimenez Díaz|
|Hospital 12 Octubre|
|Hospital General de Móstoles|
|Hospital Principe de Asturias de Alcalá de Henares|
|Hospital Universitario de la Princesa|
|Hospital Son Espases|
|Hospital Virgen de la Vega|
|Hospital de Donosti|
|San Sebastián, Spain|
|Hospital de la Candelaria|
|Hospital Universitario Canarias|
|Hospital Virgen de la Salud|
|Hospital Reina Sofía|
|Hospital Clinico Valladolid|
|Hospital Xeral de Vigo|
|Hospital Universitario de Alaba|
|Hospital de Basurto|
|Study Director:||Irene Garcia Pascual||Ipsen|