RELIEF Study: Lower Limb Pain Relief After Injection Cycles in Adults Suffering From Lower Limb Spasticity Following Stroke
- Conditions
- Lower Limb Spasticity
- Interventions
- Biological: Botulinum toxin type A
- Registration Number
- NCT02020980
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 186
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Post-stroke lower limb spasticity patients Botulinum toxin type A -
- Primary Outcome Measures
Name Time Method Change in Pain relief on Numeric Rating Scale 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).
- Secondary Outcome Measures
Name Time Method Responder rate using goal Attainment Scale 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.
Change in Pain relief on Visual Assessment Scale 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).
Trial Locations
- Locations (28)
Hospital Marítimo Oza
🇪🇸A Coruña, Spain
Hospital de Cruces
🇪🇸Bilbao, Spain
Hospital Dr Negrín
🇪🇸Las Palmas De G.C., Spain
Hospital 12 Octubre
🇪🇸Madrid, Spain
Hospital Guadalajara
🇪🇸Guadalajara, Spain
Hospital General de Albacete
🇪🇸Albacete, Spain
Hospital de Basurto
🇪🇸Bilbao, Spain
Hospital de Galdácano
🇪🇸Bilbao, Spain
Hospital Virgen de la Vega
🇪🇸Salamanca, Spain
Hospital Principe de Asturias de Alcalá de Henares
🇪🇸Madrid, Spain
Hospital Gorliz
🇪🇸Bilbao, Spain
Fundación Jimenez Díaz
🇪🇸Madrid, Spain
Hospital San Pedro
🇪🇸Logroño, Spain
Hospital Alcorcón
🇪🇸Madrid, Spain
Hospital Virgen de la Salud
🇪🇸Toledo, Spain
Hospital Reina Sofía
🇪🇸Tudela, Spain
Hospital Clinico Valladolid
🇪🇸Valladolid, Spain
Hospital Universitario de la Princesa
🇪🇸Madrid, Spain
Hospital Ourense
🇪🇸Ourense, Spain
Hospital Universitario de Alaba
🇪🇸Vitoria, Spain
Hospital Insular
🇪🇸Las Palmas De G.C., Spain
Hospital General de Móstoles
🇪🇸Madrid, Spain
Hospital de la Candelaria
🇪🇸Tenerife, Spain
Hospital Universitario Canarias
🇪🇸Tenerife, Spain
Hospital Xeral de Vigo
🇪🇸Vigo, Spain
Hospital Son Espases
🇪🇸Palma de Mallorca, Spain
Hospital de Donosti
🇪🇸San Sebastián, Spain
Clinica Ubarmin
🇪🇸Pamplona, Spain