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Percutaneous plasma discectomy study

Cervical radicular pain: a randomised controlled trial comparing percutaneous plasma discectomy and anterior cervical discectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12201401
Enrollment
150
Registered
2012-04-26
Start date
2012-04-01
Completion date
Unknown
Last updated
2017-02-06

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

Conditions

Cervical radicular pain of the lower cervical spine (C4-C7) Musculoskeletal Diseases Radiculopathy

Interventions

Technique anterior cervical discectomy This operation will be performed by a neurosurgeon according to the standard guidelines of the Dutch Neurosurgeons Association Technique percutaneous plasma di

Sponsors

Erasmus Medical Centre (Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Radicular pain of the lower cervical spine (C4 ? C7) 2. Complaints of radicular pain [Visual Analogue Scale (VAS) (0-100) at least 50] as a result of a contained soft disc hernia 3. With or without neck pain 4. Without improvement in at least 8 weeks of conservative therapy

Exclusion criteria

Exclusion criteria: 1. Age below 18 and above 65 years 2. Pregnancy 3. Anticoagulant drug therapy and/or disturbed coagulation 4. Infections/ tumours 5. Previous spinal surgery in cervical region 6. Extruded disc fragment; bony spurs; calcified disc 7. Herniation > 5 mm 8. Disc: maximal 50% loss of height 9. Neurodegenerative diseases, including lesions of the spinal cord 10. Lack of cooperation of the patient 11. Patients who are not able to complete the questionnaires, according to the referring doctor 12. Drugs/medication/ alcohol addiction 13. Serious psychopathology

Design outcomes

Primary

MeasureTime frame
Intensity of the pain, measured with a Visual analogue scale (VAS). The VAS is measured in millimetres (0-100, no pain ? most intensive pain). Measured pre and post intervention.

Secondary

MeasureTime frame
1. Patient satisfaction/global perceived effect (online questionnaire) 2. Functional status (Muscle strength (MicroFet 2 Dynamometer), Physical activity (Upper Limb Activity Monitor), Sensibility (Quantitative Sensory Testing and DNIC) and online questionnaires) 3. Health-related quality of life (online questionnaire) 4. Morbidity (online questionnaire) 5. Complications (online questionnaire) 6. Medical costs (The cost analysis will be performed from a societal viewpoint in collaboration with the Institute for Medical Technology Assessment of the Erasmus University. Three categories of costs are distinguished: 6.1. Direct costs within the healthcare 6.2. Direct costs outside the healthcare system 6.3. Indirect costs outside the healthcare Measured pre and post intervention

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026