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 |
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Recruitment Status :
Completed
First Posted : December 25, 2013
Last Update Posted : July 29, 2019
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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 | Biological: Botulinum toxin type A |
| 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 |
| 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 Name: AbobotulinumtoxinA (Dysport®) |
- 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).
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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 |
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)
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 ClinicalTrials.gov identifier (NCT number): NCT02020980
Show 28 study locations
| Study Director: | Ipsen Medical Director | Ipsen |
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT02020980 |
| Other Study ID Numbers: |
A-92-52120-181 |
| First Posted: | December 25, 2013 Key Record Dates |
| Last Update Posted: | July 29, 2019 |
| Last Verified: | July 2019 |
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Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Botulinum Toxins Botulinum Toxins, Type A |
abobotulinumtoxinA 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 |