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

NCT ID: NCT00476684

Last Updated: 2017-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neck Pain Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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radiofrequency neurotomy

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

Group Type EXPERIMENTAL

radiofrequency treatment

Intervention Type PROCEDURE

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

sham controls

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

Group Type SHAM_COMPARATOR

sham neurotomy

Intervention Type PROCEDURE

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

Interventions

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radiofrequency treatment

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

Intervention Type PROCEDURE

sham neurotomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Petter C. Borchgrevink, prof. PhD MD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Tarjei Rygnestad, Prof. PhD MD

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

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Pain Clinic, University Hospital of Trondheim

Trondheim, , Norway

Site Status

Countries

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Norway

Other Identifiers

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023-04REK

Identifier Type: -

Identifier Source: org_study_id

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