Cerebral Palsy, Spastic, Pain
Conditions
Keywords
Randomized Controlled Trial, Placebo Controlled, Double Blinded, Botulinum Toxin Type A, Adults, Pain, Spasticity, Cerebral Palsy, Spastic, Dysport
Brief summary
The purpose of this double-blinded, placebo-controlled study is to test if treatment with Botulinum toxin-A is effective in reducing chronic muscle-related pain in adults with spastic cerebral palsy.
Interventions
DRUGDysport®
Intramuscular injections in spastic muscle with regional muscle-related pain
DRUGNormal saline
Intramuscular injections in spastic muscle with regional muscle-related pain
Sponsors
Danderyd Hospital
Karolinska University Hospital
Kristina Tedroff
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * Spastic Cerebral Palsy. * Chronic pain, related to spastic muscle. Chronic pain defined as: 1)Recurring regional pain for at least three months AND 2)Pain intensity on average for the last 24 hours ≥3 on Numerical Rating Scale. * Signed Informed consent.
Exclusion criteria
* Allergy/hypersensitivity to Dysport® or any of its components. * Pregnancy. * Women who breastfeed their children. * Treatment with Botulinum toxin-A within the last five months. * If there has been dose changes in any muscle-tone altering medication within two weeks of Visit 1. * A clear degenerative cause behind the pain as elucidated by the clinical examination (e.g. history of osteoarthritis). * Intellectual disability and/or communication impairment that disable the individual from answering the questionnaires and giving informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Six weeks after treatment | Proportion of responders derived as reduction of intensity of pain of ≥2 points on the Numerical Rating Scale (NRS) at Visit 3 (six weeks after treatment) compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of other analgesic treatment | Six weeks after treatment | Categories of change in the use of analgesic treatments, derived as Increase, No change, or Decrease at Visit 3 (six weeks after treatment), compared to baseline. |
| Pain interference | Six weeks after treatment | Proportion of responders derived as a reduction in mean interference score of ≥1 on the Brief Pain Inventory (BPI-SF) at Visit 3 (six weeks after treatment) compared to baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Spasticity | Six weeks after treatment | Proportion of responders at Visit 3 (six weeks after treatment) derived as achieving reduction of spasticity of \>1 scale steps on the Modified Ashworth Scale (MAS) |
| HRQoL (Health-Related Quality of Life) | Six weeks after treatment | Mean change at Visit 3 (six weeks after treatment) compared to baseline in the Short Form 36 v2 Health-related Quality of Life questionnaire (SF-36v2) |
| Adverse Events | Six weeks after treatment | Frequency of adverse events |
| Range of Motion | Six weeks after treatment | Proportion of responders at Visit 3 (six weeks after treatment) derived as improvement in passive joint range of motion (ROM) ≥ 10 degrees. |
| Global Impression of Change | Six weeks after treatment | Proportion of responders at Visit 3 (six weeks after treatment) in the Global Impression of Change Scale (PGIC) derived as at least Minimally improved. |
| Fatigue Severity Scale | Six weeks after treatment | Proportion of responders at Visit 3 (six weeks after treatment) in the Fatigue Severity Scale (FSS) derived as a reduction in mean score of ≥1 point. |
Countries
Sweden
Outcome results
None listed