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

May 21, 2007
March 6, 2012
August 2004
May 2010   (final data collection date for primary outcome measure)
reduction in self-reported pain intensity [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
Numerig rating scale 1 to 10
Not Provided
Complete list of historical versions of study NCT00476684 on ClinicalTrials.gov Archive Site
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The Effect of Radiofrequency-treatment on Patients With Facet-joint Pain in Cervical- and Lumbar-columna
The Effect of Radiofrequency-treatment on Patients With Facet-joint Pain in Cervical- and Lumbar-columna

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.

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Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Neck Pain
  • Low Back Pain
  • Procedure: radiofrequency treatment
    Radiofrequency-neurotomy of the medial branch at 80 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
  • Experimental: radiofrequency neurotomy
    Radiofrequency-neurotomy of the medial branch at 80 degr. C for 70 seconds, after diagnostic blocks
    Intervention: Procedure: radiofrequency treatment
  • Sham Comparator: sham controls
    Radiofrequency-neurotomy of the medial branch at 37 degr. C needle temperature for 70 seconds, after diagnostic blocks
    Intervention: Procedure: sham neurotomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
May 2011
May 2010   (final data collection date for primary outcome measure)

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)
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00476684
023-04REK
No
Norwegian University of Science and Technology
Norwegian University of Science and Technology
Not Provided
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
Norwegian University of Science and Technology
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP