Botulinum Toxin-A as a Treatment for Chronic Muscle-Related Pain in Adults With Spastic Cerebral Palsy: a Randomized Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Dysport®
- Conditions
- Pain
- Sponsor
- Kristina Tedroff
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- Pain intensity
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
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.
Investigators
Kristina Tedroff
MD, PhD. Associate Professor. Senior Consultant Physician.
Karolinska Institutet
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
- •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.
Arms & Interventions
Botulinum toxin-A (Dysport®)
Intramuscular injections of Botulinum toxin-A in spastic muscles with regional muscle-related pain
Intervention: Dysport®
Normal saline
Intramuscular injections of normal saline solution in spastic muscles with regional muscle-related pain
Intervention: Normal saline
Outcomes
Primary Outcomes
Pain intensity
Time Frame: 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 Outcomes
- Pain interference(Six weeks after treatment)
- Use of other analgesic treatment(Six weeks after treatment)