Is Treatment of the Intervertebral Disc More Effective at Short-term Than the Nerve Root in Patients With a Neck Hernia?

NCT ID: NCT01797172

Last Updated: 2013-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-07-31

Brief Summary

Pain management in a neck hernia relies initially on rest, physiotherapy, and/or oral medications. Once these treatments have failed, different alternative procedures can be applied to relief pain. Thermal treatment of the intervertebral disc (Percutaneous Cervical Nucleoplasty; PCN) is the most often applied technique on the neck with a low risk of thermal damage. A variety of published studies have demonstrated this treatment to be both safe and effective. However, treatment of the nerve root (Pulsed Radio Frequency; PRF) is also a popular type of pain treatment. The application of PRF is also a safe and useful intervention for neck pain. Although these treatment types are described in the literature, the available evidence for efficacy is not sufficient to allow definitive conclusions on the optimal therapy to be made. The purpose of this study is to investigate which technique is the most effective in terms of pain relief on short term in patients with contained cervical disc herniation: PCN or PRF?

Conditions

Contained Cervical Disc Herniation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Percutaneous Cervical Nucleoplasty

Percutaneous Cervical Nucleoplasty

Group Type: EXPERIMENTAL

Percutaneous Cervical Nucleoplasty

Intervention Type: PROCEDURE

Cervical nucleoplasty is a method of percutaneous disc decompression using a 19 Gauge Trocar 3 inch spine needle (ArthroCare Co., Sunnyvale, CA, USA) which is brought to the annulus fibrosis of the herniated disc. If in the correct position, the stylet is withdrawn and the Perc DC SpineWand (ArthroCare Co., Sunnyvale, CA, USA) is introduced. The procedure relies on so-called Coblation technology which involves removing a portion of the nucleus tissue by using radio frequency energy. More specific, it results in ablation of a portion of nucleus tissue, not with heat, but with a low-temperature (typically 40-70° C) plasma field of ionized particles.

Pulsed Radio Frequency

Pulsed Radio Frequency treatment

Group Type: ACTIVE_COMPARATOR

Pulsed Radio Frequency

Intervention Type: PROCEDURE

Pulsed Radio Frequency involves placement of a needle close to the to-be-treated nerve or dorsal root ganglion (DRG). The position is checked radiographically and by motor and sensory nerve stimulation. When the needle has been placed correctly an electrode is introduced, which conducts short bursts of radio frequency energy to nervous tissue. It is known as a non- or minimally neurodestructive technique, alternative to radio frequency heat lesions using so-called thermocoagulation. No nerve damage takes places as the temperature of the tip of the needle does not exceed 42°C. This is achieved by relatively long pauses between pulses which allow generated heat to dissipate and prevent the development of any thermal lesion.

Interventions

Percutaneous Cervical Nucleoplasty

Cervical nucleoplasty is a method of percutaneous disc decompression using a 19 Gauge Trocar 3 inch spine needle (ArthroCare Co., Sunnyvale, CA, USA) which is brought to the annulus fibrosis of the herniated disc. If in the correct position, the stylet is withdrawn and the Perc DC SpineWand (ArthroCare Co., Sunnyvale, CA, USA) is introduced. The procedure relies on so-called Coblation technology which involves removing a portion of the nucleus tissue by using radio frequency energy. More specific, it results in ablation of a portion of nucleus tissue, not with heat, but with a low-temperature (typically 40-70° C) plasma field of ionized particles.

Intervention Type: PROCEDURE

Pulsed Radio Frequency

Pulsed Radio Frequency involves placement of a needle close to the to-be-treated nerve or dorsal root ganglion (DRG). The position is checked radiographically and by motor and sensory nerve stimulation. When the needle has been placed correctly an electrode is introduced, which conducts short bursts of radio frequency energy to nervous tissue. It is known as a non- or minimally neurodestructive technique, alternative to radio frequency heat lesions using so-called thermocoagulation. No nerve damage takes places as the temperature of the tip of the needle does not exceed 42°C. This is achieved by relatively long pauses between pulses which allow generated heat to dissipate and prevent the development of any thermal lesion.

Intervention Type: PROCEDURE

Other Intervention Names

CoBlation technology; ArthroCare

Eligibility Criteria

Inclusion Criteria

• Patients are legally competent and able to understand the nature, scope and aim of the clinical investigation and have given written informed consent to participate;
• Patients of either sex and of all races have been diagnosed with radiographically confirmed contained cervical disc herniation on MRI at one level;
• Patients received a diagnostic block;
• Patients failed conservative therapy during at least six weeks;
• Patients have complaints of radicular pain with or without neck pain, corresponding the herniated level;
• Patients score >=50 mm on 100 mm Visual Analogue Scale for pain (VAS-100 mm);
• Patients are able and willing to return for follow-up evaluations;
• Patients have a stable drug regime.

Exclusion Criteria

• Patients have contraindications for intervention with PCN or PRF;
• Patients have been diagnosed with an extruded or sequestered disc fragment, spondylolisthesis, vertebral fracture or spinal stenosis;
• Patients have been diagnosed with uncovertebral or facet arthrosis;
• Patients underwent previous surgery or received any type of infiltrations at the indicated cervical level;
• Patients diagnosed with a contained cervical disc herniation >1/3 spinal canal;
• Patients with radiographically confirmed loss of >30% of disc height compared to adjacent level;
• Patients with evidence of severe disc degeneration;
• Patients suffer from uncontrolled psychological disorders;
• Patients suffer from unstable medical condition.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Willy Halim

OTHER

Sponsor Role: lead

Responsible Party

Willy Halim

MD, FIPP

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Willy Halim, MD, FIPP

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia and Pain Management, St. Anna Hospital, Geldrop, The Netherlands

Locations

Department of Anesthesia and Pain Management; St. Anna Hospital

Geldrop, North Brabant, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Jorgen Wullems, MSc

Role: CONTACT

j.wullems@st-anna.nl

0031402864524

Other Identifiers

NL39783.015.12

Identifier Type: -

Identifier Source: org_study_id