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

• Status: Active, not recruiting
• Trial end date: 0000-00-00
• Target enrollment: 186
• Participant gender: Both

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA
• Last Updated: 2016-11-30

Criteria

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)