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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02020980
Recruitment Status : Completed
First Posted : December 25, 2013
Last Update Posted : April 12, 2018
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Lower Limb Spasticity Drug: Botulinum Toxin Type A (BoNT-A) Injection

Study Type : Observational
Actual Enrollment : 186 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : April 2014
Actual Primary Completion Date : March 5, 2018
Actual Study Completion Date : March 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Group/Cohort Intervention/treatment
Post-stroke lower limb spasticity patients Drug: Botulinum Toxin Type A (BoNT-A) Injection

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.

Primary Outcome Measures :
  1. Change in Pain relief on Numeric Rating Scale [ Time Frame: 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 :
  1. Change in Pain relief on Visual Assessment Scale [ Time Frame: 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).

  2. Responder rate using goal Attainment Scale [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with post-stroke lower limb spasticity in Rehabilitation and Neurology Units of hospitals.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02020980

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, Spain
Sponsors and Collaborators
Study Director: Irene Garcia Pascual Ipsen

Responsible Party: Ipsen Identifier: NCT02020980     History of Changes
Other Study ID Numbers: A-92-52120-181
First Posted: December 25, 2013    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents