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The Effect of Radiofrequency-treatment on Patients With Facet-joint Pain in Cervical- and Lumbar-columna

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00476684
First received: May 21, 2007
Last updated: March 6, 2012
Last verified: March 2012
History of Changes
  Purpose

There is conflicting evidence on whether radio-frequency neurotomy of the medial branch has a significant effect on pain in patients with chronic unilateral facet joint neck and back pain.

We will evaluate radiofrequency treatment on medial-branch of the ramus dorsalis as an effective pain treatment for patients with chronic pain originated from facet-joints in cervical and lumbar columna.


Condition Intervention
Neck Pain
Low Back Pain
 Procedure: radiofrequency treatment
Procedure: sham neurotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Radiofrequency-treatment on Patients With Facet-joint Pain in Cervical- and Lumbar-columna

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • reduction in self-reported pain intensity [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    Numerig rating scale 1 to 10


Enrollment: 28
Study Start Date: August 2004
Study Completion Date: May 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: radiofrequency neurotomy
Radiofrequency-neurotomy of the medial branch at 80 degr. C for 70 seconds, after diagnostic blocks
 Procedure: radiofrequency treatment
Radiofrequency-neurotomy of the medial branch at 80 degr. C needle temperature for 70 seconds, after diagnostic blocks
Sham Comparator: sham controls
Radiofrequency-neurotomy of the medial branch at 37 degr. C needle temperature for 70 seconds, after diagnostic blocks
 Procedure: sham neurotomy
Radiofrequency-neurotomy of the medial branch at 37 degr. C needle temperature for 70 seconds, after diagnostic blocks

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • one-sided neck and low back chronic pain
  • pain durability of at least 1 year

Exclusion Criteria:

  • other somatic or psychiatric disorders
  • pregnancy
  • stated co-morbidity
  • anaesthetics intolerance
  • no effect of diagnostic blockades (one or two)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476684

Locations
Norway
Pain Clinic, University Hospital of Trondheim
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Petter C. Borchgrevink, prof. PhD MD Norwegian University of Science and Technology
Study Director: Tarjei Rygnestad, Prof. PhD MD Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00476684     History of Changes
Other Study ID Numbers: 023-04REK
Study First Received: May 21, 2007
Last Updated: March 6, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
radiofrequency

Additional relevant MeSH terms:
Back Pain
Neck Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013