Botulinum Toxin-A as a Treatment for Chronic Muscle-Related Pain in Adults With Spastic Cerebral Palsy: a Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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Botulinum Toxin-A as a Treatment for Chronic Muscle-Related Pain in Adults With Spastic Cerebral Palsy: a Randomized Controlled Trial

Conditions
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Pain, Cerebral Palsy, Spastic

Intervention / Treatment
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* Drug: Dysport®
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Botulinum toxin-A (Dysport®)<br>Intramuscular injections of Botulinum toxin-A in spastic muscles with regional muscle-related pain | Drug: Dysport®<br>* Intramuscular injections in spastic muscle with regional muscle-related pain<br>* Other names: AbobotulinumtoxinA;|
| Placebo Comparator: Normal saline<br>Intramuscular injections of normal saline solution in spastic muscles with regional muscle-related pain | Drug: Normal saline<br>* Intramuscular injections in spastic muscle with regional muscle-related pain<br>* Other names: Physiological saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | 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. | Six weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of other analgesic 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. | Six weeks after treatment | 
| Pain interference | 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. | Six weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Controlled Trial, Placebo Controlled, Double Blinded, Botulinum Toxin Type A, Adults, Pain, Spasticity, Cerebral Palsy, Spastic, Dysport