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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:
ClinicalTrials.gov Identifier:
NCT00476684
First Posted: May 22, 2007
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  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
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Radiofrequency-treatment on Patients With Facet-joint Pain in Cervical- and Lumbar-columna

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 ]
    Numerig rating scale 1 to 10


Enrollment: 28
Actual 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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00476684     History of Changes
Other Study ID Numbers: 023-04REK
First Submitted: May 21, 2007
First Posted: May 22, 2007
Last Update Posted: August 22, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
radiofrequency

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