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

N/ACompletedNCT02020980

Ipsen186 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

186

Conditions

Lower Limb Spasticity

Interventions

Botulinum toxin type ABIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (28)

Hospital Marítimo Oza

A Coruña, Spain

Hospital General de Albacete

Albacete, Spain

Hospital de Basurto

Bilbao, Spain

Hospital de Cruces

Bilbao, Spain

Hospital de Galdácano

Bilbao, Spain

Hospital Gorliz

Bilbao, Spain

Hospital Guadalajara

Guadalajara, Spain

Hospital Dr Negrín

Las Palmas de Gran Canaria, Spain

Hospital Insular

Las Palmas de Gran Canaria, Spain

Hospital San Pedro

Logroño, Spain

...and 18 more locations

Outcomes

Primary Outcomes

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).

Time frame: Baseline visit and every 4 months up to 16 months (Visit 5).

Secondary Outcomes

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).

Time frame: 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.

Time frame: Every 4 months up to 16 months (Visit 5).