Chronic Pain, Life Style Factors and Quality of Life

January 24, 2017 updated by: Tarja Heiskanen, Helsinki University Central Hospital
Chronic pain, life style factors and quality of life (KROKIETA) is a multicenter study that aims to analyze life style factors, socioeconomic and psychometric properties, metabolic problems, drug use, quality of life and biochemical variables in chronic non-cancer pain patients. The life style factors will be compared to those of normal population. At baseline, the study patients fill in questionnaires (A-E), the patients´ weight, length, waist and blood pressure are measured, pain-related factors are recorded and blood samples taken. Changes in the quality of life of the study patients will be evaluated by questionnaires during follow-up at 2 years and 5 years.

Study Overview

Status

Completed

Conditions

Detailed Description

Chronic pain co-occurs with risk factors for cardiovascular diseases, depression, smoking and sleep problems. Nutrition and low physical activity may predispose to chronic pain. To gain information on the life style factors of adult chronic pain patients referred to university hospital or central hospital pain clinics in Finland, 477 patients have been recruited to the study. The patients fill in questionnaires on sociodemographic factors, pain, medication, use of health services, physical activity, smoking, use of alcohol or other substances, sleep, quality of life, nutrition and psychological factors at their first visit to the pain clinic. Height, weight, waist circumference, blood pressure and pulse are measured by the study nurse. A blood sample for analysis of blood sugar, cholesterol (total, LDL, HDL), triglycerides, HbA1c and sensitive C-reactive protein (CRP) is taken. The pain clinician records the pain diagnosis, medication and other methods of pain management chosen. The patients will be sent follow-up questionnaires at 2 years and 5 years after baseline.

Study Type

Observational

Enrollment (Actual)

477

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult, Finnish-speaking patients, aged 18-75 years, referred to a pain clinic for multidisciplinary pain treatment.

Description

Inclusion Criteria:

  • age 18 to 75 years
  • chronic non-cancer pain
  • Finnish-speaking
  • referred to a multidisciplinary pain management center

Exclusion Criteria:

  • inability to fill in questionnaires in Finnish
  • cancer pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
chronic pain patients
Finnish speaking, adult chronic pain patients, aged 18 - 75 years, referred to pain clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of quality of life as assessed by 15 Dimensions questionnaire between baseline and 2 years
Time Frame: 2 years
Baseline and 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Eija Kalso, Professor, Helsinki University Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 2, 2017

First Submitted That Met QC Criteria

January 19, 2017

First Posted (Estimate)

January 23, 2017

Study Record Updates

Last Update Posted (Estimate)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 24, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KROKIETA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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