Condition category
Musculoskeletal Diseases
Date applied
10/04/2012
Date assigned
26/04/2012
Last edited
11/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cervical radiculopathy (CR) is a common disorder of the nervous system characterized by dysfunction of a cervical spinal nerve, the roots of the nerve or both. When conservative treatment fails, surgical treatment is considered. However, it is associated with serious complications and a prolonged period of recovery. Currently, there is a trend in spinal surgery toward less invasive techniques. Nucleoplasty is the newest minimally invasive procedure for percutaneous disc decompression. To our knowledge, no studies have compared the relative harms and benefits of the treatments cervical percutaneous plasma discectomy and anterior cervical discectomy. Since the complications of open nucleotomy include a small risk of local inflammation, local pain and a longer period of recovery, it would be considered an important improvement if the same advantages of open nucleotomy could be achieved with percutaneous plasma discectomy as it is much less invasive. The aim of this study is to compare the clinical effects and cost-effectiveness of these two treatments in a group of patients with cervical radicular pain.

Who can participate?
Patients aged between 18 and 65 with cervical radicular pain with an indication for surgery, who did not improve in at least 2 months of conventional treatment.

What does the study involve? Participants will be randomly allocated to undergo either percutaneous plasma discectomy or anterior cervical discectomy. Tests and questionnaires will be used to perform a complete assessment of pain and functioning at the beginning of the study and after 3 and 12 months.

What are the possible benefits and risks of participating?
The two treatments are standard procedures in the participating treatment centres, so the patients will undergo no additional treatment and will not be exposed to any additional risks by participating in the study. The burden associated with participation is that participants will have to fill out a number of online questionnaires and will have to make three clinic visits to undergo additional tests.

Where is the study run from?
The study will include patients from the Erasmus Medical Centre in Rotterdam, the Sint Franciscus Gasthuis Rotterdam and the Albert Schweitzer Ziekenhuis in Dordrecht.

When is the study starting and how long is it expected to run for?
The study will be open to enrol participants between April 2012 and April 2015. Assessments will continue for one year following the intervention.

Who is funding the study?
Erasmus Medical Center, Rotterdam, Netherlands.

Who is the main contact?
Prof. F.J.P.M. Huygen
f.huygen@erasmusmc.nl  

Trial website

Contact information

Type

Scientific

Primary contact

Dr F.J.P.M. Huygen

ORCID ID

Contact details

Erasmus Medical Center
University of Rotterdam
Centrumlocatie
T.A.V. Centrum voor Pijngeneeskunde
Gravendijkwal 230
Rotterdam
3015 CE
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NL32745.078.10

Study information

Scientific title

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

Acronym

Study hypothesis

Current hypothesis as of 11/12/2013:
1. Percutaneous plasma discectomy is more effective than anterior cervical discectomy on pain, patient satisfaction/global perceived effect, functional status and health-related quality of life in patients with cervical radicular pain caused by a contained soft disc herniation.
2. Percutaneous plasma discectomy leads to less morbidity, complications and medical costs compared to anterior cervical discectomy in patients with cervical radicular pain caused by a contained soft disc herniation.

Previous hypothesis:
1. Percutaneous plasma discectomy is more effective than anterior cervical discectomy and conservative treatment on pain, patient satisfaction / global perceived effect, functional status and health-related quality of life in patients with cervical radicular pain caused by a contained soft disc herniation.
2. Percutaneous plasma discectomy leads to less morbidity, complications and medical costs compared to anterior cervical discectomy in patients with cervical radicular pain caused by a contained soft disc herniation.

Updated 11/12/2013: Unfortunately, we had problems with the inclusion of our plasma discectomy study, therefore we decided to drop the conservative care intervention. Eligible patients indicated that they didn’t want to participate in this study, because they had already had conservative care. Because of the pain and the endurance of complaints they didn’t want to be randomised in a conservative care intervention again. Through an amendment we adjusted our research protocol. The medical ethical committee of the Erasmus Medical Center approved our amendment on 10/10/2013. The reference number of this approved amendment is NL32745 078 V11_METC191658. The following changes were made to the trial record as a result (other changes are indicated in the corresponding fields):

1. The scientific title was changed from 'Cervical radicular pain: a randomised controlled trial comparing percutaneous plasma discectomy, anterior cervical discectomy and conservative treatment' to 'Cervical radicular pain: a randomised controlled trial comparing percutaneous plasma discectomy and anterior cervical discectomy'

2. The study design was changed from 'Multicenter randomised controlled parallel-group study with three groups' to 'Multicenter randomised controlled parallel-group study with two groups'

Ethics approval

Erasmus Medical Centre Internal Ethics Board, 07/12/2010, ref: MEC-2010-277
Added 11/12/2013: amendment approved by the medical ethical committee of the Erasmus Medical Centre, 10/10/2013, ref: NL32745 078 V11_METC191658

Study design

Multicenter randomised controlled parallel-group study with two groups

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Intervention

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 discectomy
1. Review the ArthroCare Perc-DC SpineWand Instructions for Use, ArthroCare System 2000 Controller User’s Manual and brochures prior to using the device.
2. The same physician will perform all study-related procedures.
3. The nucleoplasty procedure will be performed using a C-arm fluoroscope with image intensification.
4. 30 minutes pre-operative prophylaxis is intravenous given with 2 grams Kefsol.
5. Use an anterior-lateral discography approach and target the center of the disc during insertion of the access needle.
6. Confirm proper placement using AP and Lateral views
7. Re-position the green marker on the needle shaft down to skin level
8. Withdraw the stylet from the needle and insert the Perc-DC Wand under fluoroscopic guidance.
9. Using fluoroscopy, monitor the deployment of the Wand beyond the tip of the needle and secure the luer-lock onto the needle hub.
10. Confirm position of the Wand tip using AP and Lateral views.
11. Connect the Wand Cable to the Patient Cable. Align the dot at the base of each connector and directly insert the male into the female connector.
12. Secure the sterile cable onto the sterile field.
13. Verify proper placement of the tip of the Wand.
14. Set the Controller at Set Point 2 or 3 and depress Coag on the Foot Pedal for one-half second. If stimulation (movement) is observed, STOP, and reposition the Wand tip.
15. While holding the needle hub securely with one hand, grasp the Perc-DC Flange with the other hand. Depress Ablation on the Foot Pedal for 3 to 5 seconds while rotating the Flange 360 degrees in a back-and-forth motion.
16. To perform an additional ablation, retract the needle with the secured Wand 2 mm, using fluoroscopic guidance to confirm correct Wand deployment. Confirm new position of Wand tip using AP and Lateral views. Repeat steps 15 and 16.
17. After the Coblation Zone has been created, withdraw the Wand with the needle from the patient.
18. Clean the skin following standard procedure, and place a sterile dressing over the needle puncture site.
19. Apply a soft cervical neck brace immediately after the procedure for 48 hours.
20. The operated level, location of entry, and evaluation of the portal(s) will be documented.

Escape medication
Pain medication according to the WHO guideline.

On 11/12/2013 the following study arm was removed from this field as a result of a protocol amendment:
Conservative care
The conservative care will be performed by local physiotherapists in accordance with the guidelines of the Dutch Physiotherapy Association.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

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

Overall trial start date

01/04/2012

Overall trial end date

01/04/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant 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

Recruitment start date

01/04/2012

Recruitment end date

01/04/2015

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Center
Rotterdam
3015 CE
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (Netherlands)

Sponsor details

c/o Dr. J.G. Groeneweg
University of Rotterdam
Centrumlocatie
T.A.V. Centrum voor Pijngeneeskunde
Gravendijkwal 230
Rotterdam
3015 CE
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Erasmus Medical Centre (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes