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

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ClinicalTrials.gov Identifier: NCT02020980
Recruitment Status : Completed
First Posted : December 25, 2013
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date December 19, 2013
First Posted Date December 25, 2013
Last Update Posted Date July 29, 2019
Study Start Date April 2014
Actual Primary Completion Date March 5, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 19, 2013)
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 19, 2013)
  • 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).
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title RELIEF Study: Lower Limb Pain Relief After Injection Cycles in Adults Suffering From Lower Limb Spasticity Following Stroke
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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients with post-stroke lower limb spasticity in Rehabilitation and Neurology Units of hospitals.
Condition Lower Limb 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.

Other Name: AbobotulinumtoxinA (Dysport®)
Study Groups/Cohorts Post-stroke lower limb spasticity patients
Intervention: Biological: Botulinum toxin type A
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 30, 2016)
186
Original Estimated Enrollment
 (submitted: December 19, 2013)
184
Actual Study Completion Date March 5, 2018
Actual Primary Completion Date March 5, 2018   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT02020980
Other Study ID Numbers A-92-52120-181
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ipsen
Study Sponsor Ipsen
Collaborators Not Provided
Investigators
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date July 2019