Percutaneous Cervical Nucleoplasty vs. Pulsed Radio Frequency in patients with contained cervical disc herniation; a double-blind randomized clinical trial

Percutaneous Cervical Nucleoplasty vs. Pulsed Radio Frequency in patients with contained cervical disc herniation; a double-blind randomized clinical trial - Percutaneous Cervical Nucleoplasty vs. Pulsed Radio Frequency

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37639

Enrollment

Registered

2012-05-31

Start date

2012-10-19

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Hernia Nuclei Pulposi and disc herniation

Interventions

Included patients will be randomized into either of two study groups, receiving cervical nucleoplasty or PRF.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Diagnosed with radiographically confirmed contained cervical disc herniation on MRI at one level - Received a diagnostic block - Failed conservative therapy during at least six weeks - Radicular pain with or without neck pain, corresponding to herniated level - VAS-100 mm pain score at least 50 mm or higher - Patients have a stable drug regime

Exclusion criteria

Exclusion criteria: - Contraindication for intervention with nucleoplasty or pulsed radio frequency - Sequestered or extruded disc fragment, spondylolisthesis, vertebral fracture or spinal stenosis - Uncovertebral or facet arthrosis - Previous surgery or any type of infiltrations at the indicated cervical level - Contained cervical disc herniation >1/3 spinal canal - Radiographically confirmed loss of >30% disc height compared to adjacent cervical level - Severe disc degeneration - Unstable medical condition

Design outcomes

Primary

Measure	Time frame
The main study parameter to measure efficacy of both treatments is pain. Pain is measured using a 100 mm Visual Analogue Scale (VAS-100 mm) and a Verbal Rating Scale using 5 categories (VRS-5).	—

Secondary

Measure	Time frame
Secondary endpoints will include: - The Short Form 12-item questionnaire for general health (SF-12); - The Neck Disability Index (NDI) for neck functioning during ADL; - The Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV) for assessing a number of dimensions of chronic pain experience, including pain intensity, emotional distress, cognitive and functional adaptation, and social support; - Changes in limitations in sports and work, including return to work-rate; - Recording of (serious) adverse events ((S)AEs) to investigate the safety of both treatments, focusing on the number and percentage of (S)AEs. Also the intensity of treatment related adverse events will be reported; - Patients study diary for cost-effectiveness evaluation, including use of (escape) medication and physician visit(s); - Difference in patients drug regime before and after treatment; - Patient satisfaction with treatment (result) measured dichotomously via a question and continuously via VAS-100 mm.	—

Measure

Time frame

Secondary endpoints will include: - The Short Form 12-item questionnaire for general health (SF-12); - The Neck Disability Index (NDI) for neck functioning during ADL; - The Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV) for assessing a number of dimensions of chronic pain experience, including pain intensity, emotional distress, cognitive and functional adaptation, and social support; - Changes in limitations in sports and work, including return to work-rate; - Recording of (serious) adverse events ((S)AEs) to investigate the safety of both treatments, focusing on the number and percentage of (S)AEs. Also the intensity of treatment related adverse events will be reported; - Patient*s study diary for cost-effectiveness evaluation, including use of (escape) medication and physician visit(s); - Difference in patient*s drug regime before and after treatment; - Patient satisfaction with treatment (result) measured dichotomously via a question and continuously via VAS-100 mm.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)