RELIEF Study: Lower Limb Pain Relief After Injection Cycles in Adults Suffering From Lower Limb Spasticity Following Stroke
RELIEF
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
1 other identifier
observational
186
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2014
Longer than P75 for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2013
CompletedFirst Posted
Study publicly available on registry
December 25, 2013
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2018
CompletedJuly 29, 2019
July 1, 2019
3.9 years
December 19, 2013
July 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change in Pain relief on Visual Assessment Scale
Baseline visit and every 4 months up to 16 months (Visit 5).
Responder rate using goal Attainment Scale
Every 4 months up to 16 months (Visit 5).
Study Arms (1)
Post-stroke lower limb spasticity patients
Interventions
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 Criteria
Adult patients with post-stroke lower limb spasticity in Rehabilitation and Neurology Units of hospitals.
You may qualify if:
- Men or women age 18 years and above
- Post-stroke lower-limb spasticity
- Prior agreement with the patient to inject BoNT-A
- Therapeutic goals agreed jointly with the patient
- Functional Ambulation Classification (FAC) score 2-5
- Capacity to comply with the protocol
- Written informed consent
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (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
Fundación Jimenez Díaz
Madrid, Spain
Hospital 12 Octubre
Madrid, Spain
Hospital Alcorcón
Madrid, Spain
Hospital General de Móstoles
Madrid, Spain
Hospital Principe de Asturias de Alcalá de Henares
Madrid, Spain
Hospital Universitario de la Princesa
Madrid, Spain
Hospital Ourense
Ourense, Spain
Hospital Son Espases
Palma de Mallorca, Spain
Clinica Ubarmin
Pamplona, Spain
Hospital Virgen de la Vega
Salamanca, Spain
Hospital de Donosti
San Sebastián, Spain
Hospital de la Candelaria
Santa Cruz de Tenerife, Spain
Hospital Universitario Canarias
Santa Cruz de Tenerife, Spain
Hospital Virgen de la Salud
Toledo, Spain
Hospital Reina Sofía
Tudela, Spain
Hospital Clinico Valladolid
Valladolid, Spain
Hospital Xeral de Vigo
Vigo, Spain
Hospital Universitario de Alaba
Vitoria-Gasteiz, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2013
First Posted
December 25, 2013
Study Start
April 1, 2014
Primary Completion
March 5, 2018
Study Completion
March 5, 2018
Last Updated
July 29, 2019
Record last verified: 2019-07