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

Lower Limb Spasticity Clinical Trial

— RELIEF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02020980
• Other study ID #: A-92-52120-181
• Status: Completed
• Start date: April 2014
• Est. completion date: March 5, 2018

Study information

• Verified date: July 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: March 5, 2018
• Est. primary completion date: March 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lower Limb Spasticity
• Muscle Spasticity

Intervention

Biological:
• Botulinum toxin type A
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.

Locations

Country	Name	City	State
Spain	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 G.C.
Spain	Hospital Insular	Las Palmas De G.C.
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	Tenerife
Spain	Hospital Universitario Canarias	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

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	Baseline visit and every 4 months up to 16 months (Visit 5).
Secondary	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.	Every 4 months up to 16 months (Visit 5).