AI CuratorAI-generated
Research summary · AI summary · not yet reviewedHuman studyInterventionalTrial registry record – peer review not applicable
Interventional Study of FlowOx 2.0 in People with Multiple Sclerosis
The study is designed to assess the effects of intermittent negative pressure treatment (using FlowOx 2.0) on spasticity in people with multiple sclerosis (pwMS) over six months. Involving 56 participants, it includes a comparison of the actual device and a sham treatment in a randomized and controlled setup.
- Tags
- #MSResearch
- Most relevant to
- —
- Source
- Read original source
This plain-English summary was written by AI from a trial registry record and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
- Human efficacy
- Not yet assessed
- Mechanism
- Not yet assessed
- Evidence strength
- Not yet assessed
- Outcome
- Not yet assessed
Why it matters
This research could reveal new treatment options for managing spasticity in pwMS, potentially improving their quality of life.
What this does not prove
No results from the study are posted yet, and the planned enrolment and endpoints do not indicate findings.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 56 · Actual
- Randomised
- Yes
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- No
- Research areas
- Not classified
Original sources
Supporting passages (13)
study design"studyType": "INTERVENTIONAL"
subjectsEfficacy and Safety of Intermittent Negative Pressure Treatment on Spasticity and Spasticity-Related Symptoms in Patients with Multiple Sclerosis: A Two-Arm Randomized Trial.
sample size"count": 56
sample size basis"type": "ACTUAL"
randomized"allocation": "RANDOMIZED"
controlled"interventionModelDescription": "Randomized, controlled, parallel design"
regulatory approval"isFdaRegulatedDrug": false
intervention"description": "The investigational device (FlowOx2.0) is composed of a Pressure Chamber and a Control Unit (and disposable parts).
comparatorFlowOx2.0™ generating -40 mmHg is the investigational device, and FlowOx2.0™ generating -10 mmHg, is the comparator device.
primary endpoint"measure": "Change in self-reported spasticity using Numeric Rating Scale (NRS)"
follow upThis part is an open investigation in which all randomized subjects that have completed the main part are offered to continue for an additional 6 months using the active device (INP pulses of - 40 mmHg)."
findings"briefSummary": "The study is a 4-week double-blind, randomized, controlled, parallel design investigation to investigate the impact of intermittent negative pressure on spasticity and pain in people with multiple sclerosis (pwMS).
limitationsNo results are posted. Planned enrolment and endpoints are not findings.
AI assessment, not yet reviewed by a person · version 1 · Community votes are separate from evidence review.