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

Primary Purpose

Neck Pain, Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
radiofrequency treatment
sham neurotomy
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring radiofrequency

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Pain Clinic, University Hospital of Trondheim

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

radiofrequency neurotomy

sham controls

Arm Description

Radiofrequency-neurotomy of the medial branch at 80 degr. C for 70 seconds, after diagnostic blocks

Radiofrequency-neurotomy of the medial branch at 37 degr. C needle temperature for 70 seconds, after diagnostic blocks

Outcomes

Primary Outcome Measures

reduction in self-reported pain intensity
Numerig rating scale 1 to 10

Secondary Outcome Measures

Full Information

First Posted
May 21, 2007
Last Updated
August 17, 2017
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT00476684
Brief Title
The Effect of Radiofrequency-treatment on Patients With Facet-joint Pain in Cervical- and Lumbar-columna
Official Title
The Effect of Radiofrequency-treatment on Patients With Facet-joint Pain in Cervical- and Lumbar-columna
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 2004 (Actual)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Low Back Pain
Keywords
radiofrequency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
radiofrequency neurotomy
Arm Type
Experimental
Arm Description
Radiofrequency-neurotomy of the medial branch at 80 degr. C for 70 seconds, after diagnostic blocks
Arm Title
sham controls
Arm Type
Sham Comparator
Arm Description
Radiofrequency-neurotomy of the medial branch at 37 degr. C needle temperature for 70 seconds, after diagnostic blocks
Intervention Type
Procedure
Intervention Name(s)
radiofrequency treatment
Intervention Description
Radiofrequency-neurotomy of the medial branch at 80 degr. C needle temperature for 70 seconds, after diagnostic blocks
Intervention Type
Procedure
Intervention Name(s)
sham neurotomy
Intervention Description
Radiofrequency-neurotomy of the medial branch at 37 degr. C needle temperature for 70 seconds, after diagnostic blocks
Primary Outcome Measure Information:
Title
reduction in self-reported pain intensity
Description
Numerig rating scale 1 to 10
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petter C. Borchgrevink, prof. PhD MD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tarjei Rygnestad, Prof. PhD MD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Pain Clinic, University Hospital of Trondheim
City
Trondheim
ZIP/Postal Code
7006
Country
Norway

12. IPD Sharing Statement

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

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