AI CuratorAI-generated

Research summary · 6 d ago

AI summary · not yet reviewedSubjects not reportedNot reportedTrial registry record – peer review not applicable

Investigational Device Study in People with Multiple Sclerosis

A study investigating the device FlowOx 2.0 aims to see how intermittent negative pressure impacts spasticity and pain in people with multiple sclerosis over 4 weeks. It involved 58 subjects and included both a FlowOx 2.0 intervention and a comparator with reduced pressure. Results are expected after a 6-month follow-up, but actual findings are not yet available.

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 may provide insights into non-pharmaceutical approaches for managing spasticity in MS, which is a significant symptom affecting quality of life.

What this does not prove

Results have not been posted, so conclusions about efficacy or safety cannot yet be drawn. Since it's a planned study, outcomes remain unknown.

Next milestone

No next milestone was established from the available source.

Study facts

Study design: Not reported
Participants / samples: 58 · 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

Trial registrationPerformance and Long-term Safety of FlowOx2.0™, Multiple Sclerosis, Spasticity and Pain ↗

Supporting passages (11)

sample size"count": 58

sample size basis"type": "ACTUAL"

randomized"allocation": "NA"

controlled"interventionModel": "SINGLE_GROUP"

regulatory approval"isFdaRegulatedDrug": false

intervention"FlowOx 2.0"

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 up"timeFrame": "6 months"

findings"briefSummary": "This study is based on 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) (NCT05562453).

limitationsNo results are posted.

AI assessment, not yet reviewed by a person · version 1 · Community votes are separate from evidence review.