RFD Versus Cervical Medial Branch Blocks in Chronic Degenerative Neck Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Maastricht University Medical Center
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01743326
First received: November 21, 2012
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

Rationale: the facet joints are an important pain generator in chronic neck pain. The beneficial effect of radio frequency treatment (RFD) of the cervical facet joints has been described in a Randomized Clinical Trial (RCT) in patients with Whiplash Associated Disorders. In patients with degenerative neck complaints a positive effect has been described in observational studies. Given this positive effect performing a RCT of RFD in this patient population is indicated.

Objective: to evaluate the effect of Radio Frequency treatment in patients with chronic degenerative neck pain.

Study design: prospective, randomized, double blinded clinical trial. Study population: patients older than 25 years, referred to the University Pain Center of Maastricht and the Pain Center of Amphia hospital Breda, with chronic axial neck pain.

Intervention: patients with at least 3 months of neck pain without radiation to the arm (only radiation beyond the shoulder) will be randomized in 2 groups. The first group (RFD + local anesthesia-group=intervention group) will receive RF treatment adjacent to the medial branch innervating the cervical facet joints after the application of bupivacaine 0.5 ml (0.25%). The second group (local anesthesia-group=control group) will only receive the application of 0.5 ml bupivacaine (0.25%) adjacent to the medial branch. The only difference between the two groups is the RF-denervation of the medial branches.

Main study parameters/endpoints: the primary research question is to evaluate the extent of pain reduction induced by RF treatment (RFD + local anesthesia-group=intervention group) compared with the local anesthesia-group(control group.

Following evaluation tools are used : Numeric Rating Scale (NRS), Patient global Impression of Change on a 7 point Likert Scale (PGIC), consumption of pain medication (MQS), Patient Specific Functional Scale, Quality of life scale (RAND 36), Hospital Anxiety and Depression scale (HADS), and Neck Disability Index (NDI, Dutch version).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients in the RFD + Local Anesthesia-group and Local Anesthesia-group will undergo a physical examination before and 6 weeks after the intervention, by an independent third party, this will be repeated at 3 and 6 months if abnormalities are observed. At each of these time points the patients will receive questionnaires to fill out. A puncture of a blood vessel is possible, diagnosed by injection of contrast, for which repositioning of the needle is needed. Should accidental intravascular injection of local anesthetic occur, the dose used is low and reports show that intravascular injection of bupivacaine 2,5 mg does not pose clinical problems. The dura can be punctured; as a consequence contrast will flow in the cerebrospinal fluid. The procedure will be stopped and repeated after a few days. In theory a lesion of the nerve root is possible, but the needles are designed to avoid this, this complication has not been seen since more than 10 years. Up till now, a transient pain is occasionally described after the RF treatment. No hypesthesia or motor complications were reported. Since the risks of RF treatment are reported low and more related to needle placement there is no difference in risk and burden between the two treatment groups.


Condition Intervention
Facet Joint Arthritis
Pain
Radiofrequency Denervation
Procedure: Radio Frequency Denervation
Procedure: Local Anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Percutaneous Radiofrequency Denervation of the Cervical Facet Joints Compared With Cervical Medial Branch Block of the Facet Joints for Patients With Chronic Degenerative Neck Pain : A Prospective Randomized Clinical Study

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Mean pain intensity measured on a 11-point Numeric Rating Scale (NRS). [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change according to a 7-point Likert scale (PGIC). [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Changes in use of pain medication according to the Medication Quantification Scale (MQS). [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Changes in the Neck Disability Index scale (NDI). [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in quality of life and differences between groups by means of RAND 36. [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Improvement in functionality measured by the Patient Specific Functional Scale. [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Change in physical/neurological examination parameters. [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Change in employment status. [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: November 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RFD-group
Radio Frequency Denervation
Procedure: Radio Frequency Denervation Procedure: Local Anesthesia
Active Comparator: Local Anesthesia-group
Local Anesthesia-group
Procedure: Local Anesthesia

  Eligibility

Ages Eligible for Study:   25 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient's age > 25 year
  • Signs of degeneration on lateral X-ray
  • Cervical facets to be treated between C2 and C7
  • Pain for at least 3 months and conservative treatment medication (=paracetamol, Non-Steroidal anti-inflammatory Drugs (NSAID) and/or physical therapy) prior to referral to the pain clinic
  • Neck pain on a Numeric Rating Scale ≥ 5

Exclusion Criteria:

  • Radiation beyond the shoulder/radicular pain
  • Shoulder pain/pathology
  • The complaints are directly related to traumatic event e.g. Whiplash (WAD)
  • Patient is pregnant, or pregnancy is suspected
  • Patient has a cardiac pacemaker, automatic defibrillator or any leads in the neck area
  • Allergy to contrast media or drugs to be used in the procedure
  • History of anterior fusion at the cervical level to be treated
  • Patient is simultaneously participating in another device or drug study related to cervical pain.
  • Patient has a spinal fracture, tumor or infection.
  • Patient has a central cord lesion in the cervical spine
  • Neurologic deficit
  • Evidence of disc herniation (extruded, sequestered on MRI imaging)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743326

Contacts
Contact: Maarten van Eerd, MD +31 43 3875606 mveerd@gmail.com
Contact: Nelleke de Meij, MSc +31 43 3872335 p.de.meij@mum.nl

Locations
Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Limburg, Netherlands
Contact: Maarten van Eerd, MD    +31 43 3875606    mveerd@gmail.com   
Contact: Nelleke de Meij, MSc    +31 43 3872335    p.de.meij@mumc.nl   
Principal Investigator: Maarten v Kleef, Prf. MD         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Maarten van Kleef, Prf. MD Maastricht University Medical Centre
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01743326     History of Changes
Other Study ID Numbers: METC 12-2-031
Study First Received: November 21, 2012
Last Updated: December 13, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Zygapophyseal Joint

Additional relevant MeSH terms:
Arthritis
Neck Pain
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014