(Cost)effectiveness of a personalized multimodal physical therapy program compared to surgery in patients with cervical radiculopathy: a randomized non-inferiority trial
- Conditions
- Cervical radiculopathyneck herniation10041543
- Registration Number
- NL-OMON56220
- Lead Sponsor
- Vrije Universiteit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 126
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.
myelopathy, motor deficits measured by Medical Research
Council (MRC) scale for muscle strength<=3, previous neck surgery, psychiatric
disorders, systemic disease (e.g. rheumatoid arthritis), malignancies or
pregnancy. In case of myelopathy or MRC strength<=3, surgery will immediately be
preferred instead of a conservative policy due to the risk of permanent
disability.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome for non-inferiority is disability over a 12-month period. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are arm and neck pain intensity, self-perceived recovery,<br /><br>fear of movement, treatment adherence, health-related quality of life,<br /><br>patient-specific activities, patient-acceptable symptom state, return-to-work,<br /><br>medication use, costs, percentages cross-overs, (re)surgeries, and<br /><br>complications. Additionally, transcriptomics of peripheral immune cells will be<br /><br>performed at baseline and 6 months follow up to compare gene expression<br /><br>profiles between patients who recover and those who do not.</p><br>