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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02434549
• Date of registration: 30/04/2015
• Prospective Registration: Yes
• Primary sponsor: Kristina Tedroff
• Public title: Botulinum Toxin-A as a Treatment for Chronic Muscle-Related Pain in Adults With Spastic Cerebral Palsy: a Randomized Controlled Trial BATCP
• Scientific title: Botulinum Toxin-A as a Treatment for Chronic Muscle-Related Pain in Adults With Spastic Cerebral Palsy: a Randomized Controlled Trial
• Date of first enrolment: August 2015
• Target sample size: 16
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02434549
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Sweden

Contacts

• Name: Kristina Tedroff, MD, PhD
• Affiliation: Associate Professor, Department of Women's and Children's Health, Karolinska Institutet. Senior Consultant Physician, Astrid Lindgren's Children's Hospital, Stockholm, Sweden.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pain

Cerebral Palsy, Spastic

Intervention(s)

Drug: Normal saline

Drug: Dysport®

Primary Outcome(s)

Pain intensity [Time Frame: Six weeks after treatment]

Secondary Outcome(s)

Use of other analgesic treatment [Time Frame: Six weeks after treatment]

Pain interference [Time Frame: Six weeks after treatment]

Secondary ID(s)

BATCP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Danderyd Hospital

Karolinska University Hospital