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(Cost)effectiveness of a personalized multimodal physical therapy program compared to surgery in patients with cervical radiculopathy: a randomized non-inferiority trial

(Cost)effectiveness of a personalized multimodal physical therapy program compared to surgery in patients with cervical radiculopathy: a randomized non-inferiority trial - MOVE-IT:

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56220
Enrollment
126
Registered
2023-11-13
Start date
2024-05-16
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical radiculopathy neck herniation

Interventions

Intervention: A personalized multimodal physical therapy program consisting of neuromobilizations, cervical mobilizations, exercise, pain education, behavioral therapy depending on the clinical find

Sponsors

Vrije Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with CR with an indication for surgery and no contra-indication for conservative management are eligible to participate. CR is diagnosed when the patient*s clinical presentation corresponds to relevant Magnetic Resonance Imaging (MRI) findings. An e-consult between the patients and the neurosurgeon will take place to verify the indication for surgery. Further inclusion criteria: Age >=18, at least 8 weeks of unilateral arm pain and/or paraesthesia, with arm pain intensity and/or paraesthesia intensity Numeric Pain Rating Scale (NPRS) >=4/10, sensory deficits, motor deficits and/or reduced reflexes.

Exclusion criteria

Exclusion criteria: Exclusion criteria: myelopathy, motor deficits measured by Medical Research Council (MRC) scale for muscle strength

Design outcomes

Primary

MeasureTime frame
Primary outcome for non-inferiority is disability over a 12-month period.

Secondary

MeasureTime frame
Secondary outcomes are arm and neck pain intensity, self-perceived recovery, fear of movement, treatment adherence, health-related quality of life, patient-specific activities, patient-acceptable symptom state, return-to-work, pressure, heat, cold tests (QST measurements), medication use, costs, percentages cross-overs, (re)surgeries, and complications. Additionally, transcriptomics of peripheral immune cells will be performed at baseline and 6 months follow up to compare gene expression profiles between patients who recover and those who do not.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)