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

July 25, 2019 updated by: Ipsen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

186

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • A Coruña, Spain
        • Hospital Marítimo Oza
      • Albacete, Spain
        • Hospital General de Albacete
      • Bilbao, Spain
        • Hospital de Basurto
      • Bilbao, Spain
        • Hospital de Cruces
      • Bilbao, Spain
        • Hospital de Galdácano
      • Bilbao, Spain
        • Hospital Gorliz
      • Guadalajara, Spain
        • Hospital Guadalajara
      • Las Palmas De G.C., Spain
        • Hospital Dr Negrin
      • Las Palmas De G.C., Spain
        • Hospital Insular
      • Logroño, Spain
        • Hospital San Pedro
      • Madrid, Spain
        • Fundacion Jimenez Diaz
      • Madrid, Spain
        • Hospital Alcorcón
      • Madrid, Spain
        • Hospital 12 Octubre
      • Madrid, Spain
        • Hospital Universitario de La Princesa
      • Madrid, Spain
        • Hospital General de Móstoles
      • Madrid, Spain
        • Hospital Principe de Asturias de Alcalá de Henares
      • Ourense, Spain
        • Hospital Ourense
      • Palma de Mallorca, Spain
        • Hospital Son Espases
      • Pamplona, Spain
        • Clinica Ubarmin
      • Salamanca, Spain
        • Hospital Virgen de la Vega
      • San Sebastián, Spain
        • Hospital de Donosti
      • Tenerife, Spain
        • Hospital de la Candelaria
      • Tenerife, Spain
        • Hospital Universitario Canarias
      • Toledo, Spain
        • Hospital Virgen de la Salud
      • Tudela, Spain
        • Hospital Reina Sofia
      • Valladolid, Spain
        • Hospital Clínico Valladolid
      • Vigo, Spain
        • Hospital Xeral de Vigo
      • Vitoria, Spain
        • Hospital Universitario de Alaba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with post-stroke lower limb spasticity in Rehabilitation and Neurology Units of hospitals.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Post-stroke lower limb spasticity patients
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.

Other Names:
  • AbobotulinumtoxinA (Dysport®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline visit and every 4 months up to 16 months (Visit 5).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline visit and every 4 months up to 16 months (Visit 5).
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.
Every 4 months up to 16 months (Visit 5).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

March 5, 2018

Study Completion (Actual)

March 5, 2018

Study Registration Dates

First Submitted

December 19, 2013

First Submitted That Met QC Criteria

December 19, 2013

First Posted (Estimate)

December 25, 2013

Study Record Updates

Last Update Posted (Actual)

July 29, 2019

Last Update Submitted That Met QC Criteria

July 25, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-92-52120-181

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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