Clinical trial NCT02020980: RELIEF Study: Lower Limb Pain Relief After Injection Cycles in Adults Suffering From Lower Limb Spasticity Following Stroke
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Limb Spasticity
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2013-12-25
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with post-stroke lower limb spasticity in Rehabilitation and Neurology Units of hospitals.

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in Pain relief on Numeric Rating Scale
timeFrame: Baseline visit and every 4 months up to 16 months (Visit 5).
Secondary outcomes:
measure: Change in Pain relief on Visual Assessment Scale
timeFrame: Baseline visit and every 4 months up to 16 months (Visit 5).
measure: Responder rate using goal Attainment Scale
timeFrame: Every 4 months up to 16 months (Visit 5).
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Hospital Marítimo Oza
city: Albacete
country: Spain
facility: Hospital General de Albacete
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Bilbao
country: Spain
facility: Hospital de Cruces
city: Bilbao
country: Spain
facility: Hospital de Galdácano
city: Bilbao
country: Spain
facility: Hospital Gorliz
city: Guadalajara
country: Spain
facility: Hospital Guadalajara
city: Las Palmas De G.C.
country: Spain
facility: Hospital Dr Negrín
city: Las Palmas De G.C.
country: Spain
facility: Hospital Insular
city: Logroño
country: Spain
facility: Hospital San Pedro
city: Madrid
country: Spain
facility: Fundación Jimenez Díaz
city: Madrid
country: Spain
facility: Hospital 12 Octubre
city: Madrid
country: Spain
facility: Hospital Alcorcón
city: Madrid
country: Spain
facility: Hospital General de Móstoles
city: Madrid
country: Spain
facility: Hospital Principe de Asturias de Alcalá de Henares
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Ourense
country: Spain
facility: Hospital Ourense
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
city: Pamplona
country: Spain
facility: Clinica Ubarmin
city: Salamanca
country: Spain
facility: Hospital Virgen de la Vega
city: San Sebastián
country: Spain
facility: Hospital de Donosti
city: Tenerife
country: Spain
facility: Hospital de la Candelaria
city: Tenerife
country: Spain
facility: Hospital Universitario Canarias
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Tudela
country: Spain
facility: Hospital Reina Sofía
city: Valladolid
country: Spain
facility: Hospital Clinico Valladolid
city: Vigo
country: Spain
facility: Hospital Xeral de Vigo
city: Vitoria
country: Spain
facility: Hospital Universitario de Alaba
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: