The Effect of Cannabis-Based Medicine on Neuropathic Pain and Spasticity in Patients with Multiple Sclerosis and Spinal Cord Injury: Study Protocol of a National Multicenter Double-Blinded, Placebo-Controlled Trial Article Swipe
Julie Schjødtz Hansen
,
Rikke Middelhede Hansen
,
Thor Petersen
,
Stefan Gustavsen
,
Annette Oturai
,
Finn Sellebjerg
,
Eva Aggerholm Sædder
,
Helge Kasch
,
Peter Vestergaard Rasmussen
,
Nanna Brix Finnerup
,
Kristina Bacher Svendsen
·
YOU?
·
· 2021
· Open Access
·
· DOI: https://doi.org/10.3390/brainsci11091212
YOU?
·
· 2021
· Open Access
·
· DOI: https://doi.org/10.3390/brainsci11091212
Disease or acquired damage to the central nervous system frequently causes disabling spasticity and central neuropathic pain (NP), both of which are frequent in multiple sclerosis (MS) and spinal cord injury (SCI). Patients with MS and SCI often request treatment with cannabis-based medicine (CBM). However, knowledge about effects, side effects, choice of active cannabinoids (Δ9-tetrahydrocannabinol (THC), cannabidiol (CBD) alone or in combination), and doses of CBM remains limited. Using a double-blind, parallel design in a national multicenter cohort, this study examines the effect of CBM on spasticity and NP. Patients are randomized to treatment with capsules containing either THC, CBD, THC and CBD, or placebo. Primary endpoints are patient-reported pain and spasticity on a numerical rating scale. Other endpoints include quality of life and sleep, depression and anxiety, and relief of pain and spasticity. Side-effects of CBM are described. In a sub-study, the pharmacodynamics (PD) and pharmacokinetics (PK) of oral capsule CBM are examined. We expect that the study will contribute to the literature by providing information on the effects and side-effects of CBD, THC, and the combination of the two for central neuropathic pain and spasticity. Furthermore, we will describe the PD/PK of THC and CBD in a patient population.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.3390/brainsci11091212
- https://www.mdpi.com/2076-3425/11/9/1212/pdf?version=1631686069
- OA Status
- gold
- Cited By
- 12
- References
- 60
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W3199390884
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
-
https://openalex.org/W3199390884Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.3390/brainsci11091212Digital Object Identifier
- Title
-
The Effect of Cannabis-Based Medicine on Neuropathic Pain and Spasticity in Patients with Multiple Sclerosis and Spinal Cord Injury: Study Protocol of a National Multicenter Double-Blinded, Placebo-Controlled TrialWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2021Year of publication
- Publication date
-
2021-09-14Full publication date if available
- Authors
-
Julie Schjødtz Hansen, Rikke Middelhede Hansen, Thor Petersen, Stefan Gustavsen, Annette Oturai, Finn Sellebjerg, Eva Aggerholm Sædder, Helge Kasch, Peter Vestergaard Rasmussen, Nanna Brix Finnerup, Kristina Bacher SvendsenList of authors in order
- Landing page
-
https://doi.org/10.3390/brainsci11091212Publisher landing page
- PDF URL
-
https://www.mdpi.com/2076-3425/11/9/1212/pdf?version=1631686069Direct link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
-
https://www.mdpi.com/2076-3425/11/9/1212/pdf?version=1631686069Direct OA link when available
- Concepts
-
Medicine, Spasticity, Multiple sclerosis, Neuropathic pain, Spinal cord injury, Placebo, Spinal cord, Clinical trial, Physical therapy, Anesthesia, Physical medicine and rehabilitation, Internal medicine, Alternative medicine, Psychiatry, PathologyTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
12Total citation count in OpenAlex
- Citations by year (recent)
-
2025: 3, 2024: 1, 2023: 6, 2022: 1, 2021: 1Per-year citation counts (last 5 years)
- References (count)
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60Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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