Evidence map›Paper›PMID 40675989›Full record

Observational studySpinal cord series and cases2025

The effects of nabiximols (Sativex®) on spasticity and non-motor symptoms in chronic spinal cord injury (SCI): a longitudinal prospective study.

Fernando Martins Braga, Sergiu Albu, Cecilia Mariño Fernández, Virginia Martínez Santana, Jesús Benito-Penalva, Joan Vidal Samsó

Abstract readObservational Study
In one paragraph

Observational study in Spinal cord series and cases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Fernando Martins BragaFundació Institut Guttmann, Institut Universitari de Neurorehabilitació, Barcelona, Catalonia, Spain. fmartins@guttmann.com.ORCID 0009-0002-8355-4457
Sergiu AlbuFundació Institut Guttmann, Institut Universitari de Neurorehabilitació, Barcelona, Catalonia, Spain.ORCID 0000-0001-8310-4208
Cecilia Mariño FernándezFundació Institut Guttmann, Institut Universitari de Neurorehabilitació, Barcelona, Catalonia, Spain.
Virginia Martínez SantanaFundació Institut Guttmann, Institut Universitari de Neurorehabilitació, Barcelona, Catalonia, Spain.
Jesús Benito-PenalvaFundació Institut Guttmann, Institut Universitari de Neurorehabilitació, Barcelona, Catalonia, Spain.ORCID 0000-0003-1232-1808
Joan Vidal SamsóFundació Institut Guttmann, Institut Universitari de Neurorehabilitació, Barcelona, Catalonia, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

designObservational, longitudinal, prospective study.

objectivesThis study aimed to evaluate the effects of Nabiximols (Sativex®) on spasticity in chronic spinal cord injury (SCI) individuals refractory to conventional therapy. Secondary objectives included assessing its impact on functional independence, neuropathic pain, sleep quality, and depression.

settingInstitute Guttmann, a neurorehabilitation hospital in Badalona, Catalonia (Spain).

methodsAdult participants ( >18 years) with chronic SCI ( >6 months) and moderate to severe spasticity refractory to conventional treatments were recruited. All participants underwent baseline assessments and were followed up at one and two months after initiating treatment with nabiximols oromucosal spray, with individualised dose adjustments on a weekly basis. Assessed variables included spasticity, functional independence, neuropathic pain, sleep quality, depression, quality of life, and Patient Global Impression of Improvement (PGI-I).

resultsStatistically significant improvements in spasticity were observed after one month (VAS decrease of 30%, p < 0.001; MAS decrease of 60%, p = 0.001) and two months (VAS decrease of 30%, p < 0.001; MAS decrease of 52%, p = 0.011) of treatment. A positive PGI-I was reported in 67% of participants. However, no significant changes were noted in spasms frequency, functional independence, neuropathic pain, or sleep quality. No significant differences in spasticity change or non-motor symptoms were found between participants with complete and incomplete SCI.

conclusionsNabiximols may effectively reduce spasticity in individuals with SCI resistant to conventional therapies. Given the significant impact of spasticity associated with SCI, it could be considered a viable add-on therapy for this population. TRIAL REGISTRY: This clinical trial is registered in the EudraCT database under the identifier 2022-001777-31. SPONSORSHIP: Almirall, S.A., Barcelona, Catalonia (Spain).

Indexed as

CannabidiolDronabinolMuscle SpasticityPlant ExtractsSpinal Cord InjuriesAdultAgedChronic DiseaseDrug CombinationsFemaleHumansLongitudinal StudiesMaleMiddle AgedNeuralgiaProspective StudiesCannabidiolDronabinolDrug CombinationsnabiximolsPlant Extracts

Identifiers

PMID40675989
PMCPMC12271395

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.