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

Willy Halim

Status: Unknown

Conditions: Contained Cervical Disc Herniation

Treatments: Procedure: Percutaneous Cervical Nucleoplasty; Procedure: Pulsed Radio Frequency

Study type: Interventional

Funder types: Other

Identifiers

NCT01797172

NL39783.015.12

Details and patient eligibility

About

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?

Enrollment: 38 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Percutaneous Cervical Nucleoplasty

Experimental group

Description:

Percutaneous Cervical Nucleoplasty

Treatment:

Procedure: Percutaneous Cervical Nucleoplasty

Pulsed Radio Frequency

Active Comparator group

Description:

Pulsed Radio Frequency treatment

Treatment:

Procedure: Pulsed Radio Frequency