Clinical trial NCT02434549: Botulinum Toxin-A as a Treatment for Chronic Muscle-Related Pain in Adults With Spastic Cerebral Palsy: a Randomized Controlled Trial
Official title: Botulinum Toxin-A as a Treatment for Chronic Muscle-Related Pain in Adults With Spastic Cerebral Palsy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pain
Cerebral Palsy, Spastic
Keywords: Randomized Controlled Trial
Placebo Controlled
Double Blinded
Botulinum Toxin Type A
Adults
Pain
Spasticity
Cerebral Palsy, Spastic
Dysport
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Danderyd Hospital
name: Karolinska University Hospital
First posted: 2015-05-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain intensity
timeFrame: Six weeks after treatment
Secondary outcomes:
measure: Use of other analgesic treatment
timeFrame: Six weeks after treatment
measure: Pain interference
timeFrame: Six weeks after treatment
Other outcomes:
measure: HRQoL (Health-Related Quality of Life)
timeFrame: Six weeks after treatment
measure: Global Impression of Change
timeFrame: Six weeks after treatment
measure: Fatigue Severity Scale
timeFrame: Six weeks after treatment
measure: Spasticity
timeFrame: Six weeks after treatment
measure: Range of Motion
timeFrame: Six weeks after treatment
measure: Adverse Events
timeFrame: Six weeks after treatment
Locations:
city: Danderyd
country: Sweden
facility: Department of Rehabilitation Medicine at Danderyd Hospital AB
city: Stockholm
country: Sweden
facility: Astrid Lindgren's Children's Hospital at Karolinska University Hospital
Study officials:
affiliation: Associate Professor, Department of Women's and Children's Health, Karolinska Institutet. Senior Consultant Physician, Astrid Lindgren's Children's Hospital, Stockholm, Sweden.
name: Kristina Tedroff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jacobson D, Lowing K, Kullander K, Rydh BM, Tedroff K. A First Clinical Trial on Botulinum Toxin-A for Chronic Muscle-Related Pain in Cerebral Palsy. Front Neurol. 2021 Aug 16;12:696218. doi: 10.3389/fneur.2021.696218. eCollection 2021.