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Completed

NCT Number: NCT02020980

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

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.

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Key information

Conditions

Lower Limb Spasticity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Marítimo Oza, A Coruña, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Botulinum toxin type A

Biological

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®)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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

Acronym: RELIEF

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 25, 2013
Registry last updated
Jul 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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