NCT01835704

Brief Summary

To establish the cost per QALY (Quality Adjusted life Years) gained all patients that are referred to a specialized interventional pain clinic are assessed by Euroqol EQ-5D to measure the health-related quality of life at the first visit and then during the following year. Quality of life is calculated from EQ-5D by using hte TTO-validated UK-value set. With this and calculations of the cost we will be able to calculate the cost per QALY-gained which makes it possible to compare interventional pain managment to other treatments for pain patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,540

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2013

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2019

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

11.1 years

First QC Date

April 17, 2013

Last Update Submit

February 16, 2019

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • Quality Adjusted Life gained

    QALY is calculated from the EQ-5D value using the TTO-validated UK value set accoring to ordinary health-economic evaluations.

    1 year

Secondary Outcomes (1)

  • Cost per QALY gained

    1 year

Study Arms (2)

Chronic pain associated to facet-joints

Patients where the pain can be localized to the facet joints.

Other: Radio-frequency dennervation of facet joint

Chronic pain of other origin

Patients with pain that can not be localized to facet joints.

Other: Diagnostic nerve-blocks performed under direct x-ray vision

Interventions

Radio-frequency dennervation of facet jointOTHER
Chronic pain associated to facet-joints
Diagnostic nerve-blocks performed under direct x-ray visionOTHER
Chronic pain of other origin

Eligibility Criteria

Age15 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with pain of more then 6 months duration

You may qualify if:

  • All patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Smärtkliniken i Umeå

Umeå, 90325, Sweden

Location

Related Publications (1)

  • Hambraeus J, Pulkki-Brannstrom AM, Lindholm L. Cost-effectiveness of Radiofrequency Denervation for Zygapophyseal Joint Pain. Pain Physician. 2021 Dec;24(8):E1205-E1218.

    PMID: 34793647DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Johan Hambraeus, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2013

First Posted

April 19, 2013

Study Start

January 1, 2008

Primary Completion

February 3, 2019

Study Completion

February 3, 2019

Last Updated

February 19, 2019

Record last verified: 2019-02

Locations

SE(1)