The Effect of Radiofrequency-treatment on Patients With Facet-joint Pain in Cervical- and Lumbar-columna
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 21, 2007
CompletedFirst Posted
Study publicly available on registry
May 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedAugust 22, 2017
August 1, 2017
5.8 years
May 21, 2007
August 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
reduction in self-reported pain intensity
Numerig rating scale 1 to 10
up to 1 year
Study Arms (2)
radiofrequency neurotomy
EXPERIMENTALRadiofrequency-neurotomy of the medial branch at 80 degr. C for 70 seconds, after diagnostic blocks
sham controls
SHAM COMPARATORRadiofrequency-neurotomy of the medial branch at 37 degr. C needle temperature for 70 seconds, after diagnostic blocks
Interventions
Radiofrequency-neurotomy of the medial branch at 80 degr. C needle temperature for 70 seconds, after diagnostic blocks
Radiofrequency-neurotomy of the medial branch at 37 degr. C needle temperature for 70 seconds, after diagnostic blocks
Eligibility Criteria
You may qualify if:
- one-sided neck and low back chronic pain
- pain durability of at least 1 year
You may not qualify if:
- other somatic or psychiatric disorders
- pregnancy
- stated co-morbidity
- anaesthetics intolerance
- no effect of diagnostic blockades (one or two)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pain Clinic, University Hospital of Trondheim
Trondheim, 7006, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2007
First Posted
May 22, 2007
Study Start
August 1, 2004
Primary Completion
May 1, 2010
Study Completion
May 1, 2011
Last Updated
August 22, 2017
Record last verified: 2017-08