Percutaneous plasma discectomy study

Not Applicable

Completed

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

Registration Number: ISRCTN12201401

Lead Sponsor: Erasmus Medical Centre (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 150

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Patient satisfaction/global perceived effect (online questionnaire)<br>2. Functional status (Muscle strength (MicroFet 2 Dynamometer), Physical activity (Upper Limb Activity Monitor), Sensibility (Quantitative Sensory Testing and DNIC) and online questionnaires)<br>3. Health-related quality of life (online questionnaire)<br>4. Morbidity (online questionnaire)<br>5. Complications (online questionnaire)<br>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: <br>6.1. Direct costs within the healthcare<br>6.2. Direct costs outside the healthcare system<br>6.3. Indirect costs outside the healthcare<br><br>Measured pre and post intervention